A controlled evaluation of group cognitive therapy in the treatment of irritable bowel syndrome

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Behaviour Research and Therapy 45 (2007) 633–648 www.elsevier.com/locate/brat

A controlled evaluation of group cognitive therapy in the treatment of irritable bowel syndrome Edward B. Blancharda,, Jeffrey M. Lacknerb, Kathryn Sandersa, Susan Krasnerc, Laurie Keefera, Annette Paynea, Gregory D. Gudleskib, Leonard Katzb, Dianna Rowella, Mark Sykesa, Eric Kuhna, Rebecca Gusmanoa, Ann Marie Carosellab, Rebecca Firthb, Lisa Dulgar-Tullocha a Center for Stress and Anxiety Disorders, University at Albany, Albany, NY 12222, USA Behavioral Medicine Clinic, Department of Medicine, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA c Behavioral Medicine Clinic, Department of Anesthesiology, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA

b

Received 15 July 2005; received in revised form 27 June 2006; accepted 10 July 2006

Abstract We randomized, at two sites, 210 patients with Rome II diagnosed irritable bowel syndrome (IBS), of at least moderate severity, to one of three conditions: group-based cognitive therapy (CT; n ¼ 120), psychoeducational support groups (n ¼ 46) as an active control, or intensive symptom and daily stress monitoring (n ¼ 44). One hundred eighty-eight participants completed the initial treatment. Those in symptom monitoring were then crossed over to CT. For an intent to treat analysis on a composite GI symptom measure derived from daily symptom diaries, both CT and the psychoeducational support groups were significantly more improved than those in the intensive symptom monitoring condition, but the CT and psychoeducational support group did not differ. Among treatment completers on the same composite measure of GI symptoms, again, both CT and psychoeducational support groups were statistically superior to symptom monitoring but did not differ on the symptom composite, or on any other measure. On individual IBS symptoms, both CT and psychoeducational support were statistically superior to symptom monitoring on reductions in abdominal pain and tenderness and for flatulence. Patient global ratings at the end of treatment showed the two active conditions statistically superior to symptom monitoring on change in Bowel Regularity, with CT superior to symptom monitoring on reduction in overall pain and in improvement in sense of well-being. Three-month follow-up data on 175 patients revealed maintenance of significant improvement or continued significant improvement on all IBS symptoms, including the McGill Pain Questionnaire. Group CT and psychoeducational support groups continued not to differ on any measure. We thus conclude that group CT is not superior to an attention placebo control condition. r 2006 Elsevier Ltd. All rights reserved. Keywords: Irritable bowel syndrome; Group cognitive therapy; Psychoeducational support groups; Cognitive therapy for IBS

Corresponding author. Tel.: +1 518 442 4025; fax: +1 518 442 4027.

E-mail address: [email protected] (E.B. Blanchard). 0005-7967/$ - see front matter r 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.brat.2006.07.003

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Introduction Irritable bowel syndrome (IBS) is a common, often disabling, functional disorder of the lower gastrointestinal (GI) tract characterized by abdominal pain or discomfort (e.g., tenderness, bloating) associated with abnormal bowel habit (diarrhea, constipation or both). With a world-wide prevalence of 10–20%, IBS ranks high among reasons for physician visits (Sandler, 1990) and is costly in terms of medical care (Levy et al., 2001) and time lost from work (Hahn, Yan, & Strassels, 1999) and non-monetary costs such as diminished quality of life and activity limitations (Whitehead, Burnett, Cook, & Taub, 1996). At present there is no universally accepted medical treatment for the full range of IBS symptoms. For this reason there is a growing body of research concerning the efficacy of psychological treatments (for a recent comprehensive review see Blanchard, 2005; Blanchard & Scharff, 2002; or Lackner, Mesmer, Morley, Dowzer, & Hamilton, 2004). There are three broad categories of empirically validated psychological treatments: hypnotherapy (initially described by Whorwell, Prior, & Faragher, 1984); brief psychodynamic psychotherapy (initially described by Svedlund, Sjodin, Ottosson, & Dotevall, 1983) and various combinations of cognitive and/or behavioral therapies (collectively referred to as CBT). Because the interpretability of the ‘‘first generation’’ of psychological trials was based on relatively small, randomized controlled trials (RCTs) with methodological shortcomings (Lackner et al., 2004), several largerscale RCTs have been conducted with the goal of establishing more definitively the efficacy of these approaches. These trials have yielded less than overwhelming results. Creed et al. (2003) compared an interpersonally oriented version of brief psychodynamic psychotherapy, administered individually, to the selective serotonin reuptake inhibitor (SSRI), paroxetine and medical treatment as usual (TAU). Results at end of the acute treatment phase showed no differences among the three conditions on the primary outcome variable of pain, measured by visual analog scale, or the physical component score of the SF-36 (Ware, 1993). Paroxetine was superior to TAU on secondary measures of number of days with pain and overall psychological distress as measured by the global severity index of the SCL-90 (Derogatis, 1994). Both treatments were superior to TAU on the SF-36 mental component score. In no instances were there significant differences between psychotherapy and active drug. At a 12-month follow-up, the results showed no differences among the three conditions on any variable except the SF-36 physical component. On this quality of life variable, both active treatments showed greater improvement than TAU. The health care costs for IBS in the year follow-up were significantly less for the psychotherapy condition than for TAU with costs for paroxetine in between, and not different from either of the other two conditions. Drossman et al. (2003), using only female patients, compared an individually administered version of CBT, adapted from a group CBT, initially described by Toner et al. (1998), to an individually administered attention-educational condition. Simultaneously, they compared the tricyclic antidepressant, desipramine, to a medication placebo. Using an idiosyncratic composite score of pain ratings, patient satisfaction with treatment, a quality of life measure and a rating of global well being, a significant advantage for CBT over attention-education condition was found at end of treatment. Further analyses revealed that CBT was superior to the attention-educational condition on patient satisfaction ratings and ratings of global well being, but not the other variables including daily pain ratings. There was no significant difference on the composite score between CBT and desipramine nor were there differences between active drug and placebo. No longerterm follow-up results were provided, nor were data on other individual GI symptoms reported. Boyce, Talley, Balaam, Koloski, and Gruman (2003) compared their version of CBT (previously evaluated only in an uncontrolled trial [Boyce, Gilchrist, Talley, & Rose, 2000]) to relaxation training and to somewhat enhanced routine medical care. Sixty-three percent of patients were evaluated at end of treatment and 49.5% at a 10-month follow-up. Although all 3 groups had improved significantly at the follow-up point, there were no significant differences among the cases assessed in the three conditions in terms of clinical improvement of bowel symptoms at end of treatment or at follow-up. Loss of half of the sample casts doubts on conclusions. Thus, these three recent large-scale RCTs have failed to find differential effects of psychological treatments on GI symptoms. Our own recent efforts on this problem have focused exclusively on a cognitive therapy (CT) approach to the treatment of IBS, rather than to multicomponent CBT ‘‘packages’’. A series of small-scale RCTs of CT have shown good results: Greene and Blanchard (1994) found CT superior to GI symptom monitoring on a

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composite measure of GI symptoms derived from a daily symptom diary. Payne and Blanchard (1995) found the same form of CT (following the earlier treatment manual) significantly superior in GI symptom reduction to psychoeducational support groups that were equally credible to the CT and to symptom monitoring. Finally, Vollmer and Blanchard (1998) found the same CT, administered individually or in small groups, was significantly superior to GI symptom monitoring. These results led to the present RCT in which we sought to address three issues: (1) Given the potential cost savings of group treatment over more labor-intensive individual treatment, we wanted to compare the group version of CT to (a) psychoeducational support groups as a commonly available treatment that controls for attention and group meetings, and (b) to an intensive symptom monitoring condition (participants simultaneously monitored GI symptoms and daily stressors for at least 10 weeks). (2) Our primary focus was on assessing the efficacy of the two psychological treatments for the broad spectrum of GI symptoms of IBS, measured primarily by a daily symptom diary and secondarily by global ratings of improvement from both patients and blinded physician to give values comparable to the other reports described earlier. Because of space limitations, secondary focus on other variables such as level of psychological distress, quality of life and life interference, are outside the scope of this report. (3) To evaluate the generality of the treatment, we added a second site with a strong background in CT approaches to pain but without either research experience with IBS or apparent allegiance to the treatment interventions developed at the University at Albany. In other words, we exported our current group CT and psychoeducational support manuals to determine whether their therapeutic value could be achieved by other trained health professionals at another site without allegiance to the two therapies. Methods Participants Participants were recruited at each of the two academic tertiary care clinic sites, Albany, NY, and Buffalo, NY, primarily through referral of local physicians (e.g., gastroenterologists), local media coverage and community advertising. A total of 1298 consecutive individuals were screened by telephone; 520 reported a pattern (moderate to severe pain with abnormal bowel habits of at least twice weekly) of IBS-like symptoms that warranted assessment to confirm the IBS diagnosis and were given an initial assessment appointment. One hundred and three failed to keep the initial appointment, 84 were found ineligible at this point, whereas 333 participants completed the initial assessment and started the 4-week GI symptom monitoring phase; 58 (17%) dropped out and 38 were taken out for various reasons such as unreliable baseline monitoring (17) or other treatment or disease were uncovered (21) during this phase. In all, 237 participants met Rome II (Thompson et al., 1999) criteria for IBS by history and completed the initial assessment. Because this study was designed to assess efficacy for moderately to severely affected patients, we eliminated 27 patients for whom illness severity could not be confirmed through daily diaries: that is, pain ratings during the 28 days of baseline monitoring occurred so infrequently (i.e. 11 or fewer days) or mean baseline pain rating was so low (0.23 compared to 2.13 for others) during 28 days of baseline monitoring. This left 210 who were randomized to one of the three treatment conditions. Of the 210 who began treatment, 11 dropped out of CT, 6 from the psychoeducational support groups, and 5 from the symptom monitoring wait-list control, for a total dropout rate of 10.4%. Inclusion and exclusion criteria Inclusion criteria required a Rome II (Drossman, Corazziari, Talley, Thompson, & Whitehead, 2000) diagnosis (described in detail in Table 1) that was confirmed by a board certified gastroenterologist who conducted a history, medical examination, and necessary laboratory tests to exclude comorbid organic GI disease that may explain the symptoms (IBD, lactose malabsorption). (These costs were covered by the project.) A minimum age of 18 was also used. Both male and female patients were accepted. Exclusionary criteria included organic GI disease (inflammatory bowel disease or lactose malabsorption syndrome), or very low baseline diary pain ratings (see above), or the presence of a psychotic disorder, or

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Table 1 Rome II criteria for irritable bowel syndrome At least 12 weeks, which need not be consecutive, in the preceding 12 months of 1. Abdominal Discomfort or pain 2. Accompanied by two or more of the following: (a) Relieved by defecation (b) Onset associated with change in stool frequency and/or consistency (c) Onset associated with change in form or appearance of stool Supportive symptoms of the irritable bowel syndrome 1. Fewer than three bowel movements per week 2. More than three bowel movements a day 3. Hard or lumpy stools 4. Loose (mushy) or watery stools 5. Straining during a bowel movement 6. Urgency (having to rush a bowel movement) 7. Feeling of incomplete bowel movement 8. Passing mucus during a bowel movement 9. Abdominal fullness, bloating, or swelling

current severe major depression with moderate to severe suicidal ideation as determined by the SCID (see below). Additional exclusions were for current psychotherapy of any kind or lifetime exposure to CBT. Gastroenterologist’s global ratings The study gastroenterologists made independent ratings of the frequency and severity of overall IBS symptoms, abdominal pain, diarrhea and constipation, and bloating. The overall severity of IBS symptoms (0 ¼ absent, 1 ¼ mild, 2 ¼ moderate, 3 ¼ severe, or 4 ¼ very severe) was rated in a manner comparable to prior IBS research (Drossman & Thompson, 1992) and yielded 3% who were classified as mild, 35% as moderate, 53% as severe, and 9% as very severe. Table 2 shows the demographic and illness data from the 210 randomized to treatment conditions. They are subdivided into those who completed each treatment condition and the 22 treatment dropouts combined. Frequencies from each treatment site are also presented. It had been our intention to randomize patients in the approximate ratio of 2 (CT) to 1 (psychoeducational support) to 1 (symptom monitoring) in order to have sufficient patients based on a priori power calculation for a later study of cognitive processes mediating therapeutic change of CT. A priori power calculations for this study showed a power of 0.85 to detect an effect size of 5% at the p ¼ 0.05 level with the current sample. Randomization was completed at each site by its project coordinator and was based on randomizing groups of available patients to conditions in order to speed entry into the trial. A double coin flip was used: the first coin flip decided between CT and control conditions whereas the second flip assigned groups to wait list or Psychoeducation. A comparison of dropouts to treatment completers revealed a trend (p ¼ 0.057) for dropouts to have had IBS for a significantly shorter period of time (11.2 years versus 17.7 years). There were no between group differences on age, gender, race, IBS subtype, painfree days during baseline, presence of Axis I disorder, or site (Albany versus Buffalo), nor were there any significant differences among the three experimental conditions on any of these variables. Assessment procedures Written informed consent, using protocols approved by the Institutional Review Boards of each site, was obtained at the initial visit. At the initial assessment, a structured interview (Blanchard, 2001) was administered to gather a detailed description of present GI symptoms, their history, and effects on patients’ lives. We also obtained information on current psychosocial functioning and administered structured

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Table 2 Demographic and other characteristics of IBS patients in three treatment conditions and for treatment dropouts Variable

Started treatment Treatment dropouts (%) Completed treatment Albany/buffalo Male/female % Female Mean age (SD) Caucasian/minority % Caucasian Length of illness (SD) Presence of current Axis I disorder (%) Diarrhea predominant (%) Constipation predominant (%) Alternating diarrhea and constipation (%) Painfree days/month

Conditions Cognitive therapy

Psychoeducational support

Symptom monitoring

Treatment dropouts

120 11 (9.2) 109 (90.8) 33/76 24/85 77.1 48.1 (13.7) 100/9 91.7 18.9 (16.1) 82 (75.9) 39 (35.8) 24 (22.0) 46 (42.2) 5.4 (6.5)

46 6 (13.0) 40 (87.0) 18/22 3/37 92.5 51.5 (11.3) 40/0 100 18.2 (14.7) 21 (52.5) 20 (50.0) 8 (20.0) 12 (30.0) 6.2 (6.1)

44 5 (11.4) 39 (88.6) 18/21 7/32 82.1 49.8 (13.0) 38/1 97.4 13.6 (13.2) 26 (66.7) 14 (35.9) 10 (25.6) 15 (38.5) 6.8 (6.0)

— 22 — 13/9 3/19 86.4 45.8 (16.0) 21/1 95.2 11.2 (13.6) 11 (52.4) 8 (36.4) 6 (27.3) 7 (31.8) —

psychiatric interviews, the SCID (First, Spitzer, Gibbon, & Williams, 1996) and SCID-II (First, Spitzer, Gibbon, Williams, & Benjamin, 1996) to make DSM-IV (APA, 1994) diagnoses on Axis I and Axis II (personality disorders). A written summary of this information was prepared and made available to the therapist. The interviews were conducted in part by doctoral level psychologists and in part by advanced doctoral students in clinical psychology who had been trained by the site PIs. Inter-rater agreement on a subsample yielded kappa of 0.65–0.86 for broad categories such as ‘‘any anxiety disorder’’, ‘‘any mood disorder’’, etc. The initial assessment was spread over two clinic visits scheduled 2 weeks apart. Participants also completed a battery of psychological tests whose data are not a part of this report. Finally, the GI symptom diary (Blanchard, 2001) was explained and patients were asked to begin recording with it. Dependent variables: somatic symptoms Because it is somatic symptoms that cause a patient with IBS to seek treatment, and because the recent RCTs have found no differential effect of treatment on these symptoms, the question of whether the active treatment or control conditions yield significant differential reduction in IBS symptoms is our primary focus. In the GI symptom diary, participants rated the severity of each of 8 GI symptoms (abdominal pain, abdominal tenderness, bloating, diarrhea, constipation, flatulence, belching, and nausea) each day on a 0 ¼ absent, 1 ¼ mild, 2 ¼ moderate, 3 ¼ severe, 4 ¼ debilitating scale. Values derived from this diary have been shown to be sensitive to treatment effects described on patients’ global ratings (Meissner, Blanchard, & Malamood, 1997). Patients returned to the clinic after 2 weeks, at which point their understanding and compliance with the symptom monitoring task was assessed and the interview and psychological tests were completed. If the diary was apparently not completed appropriately (e.g. missing days), the patient was asked to start over and monitor for 2 more weeks with a follow-up compliance check scheduled. Patients also completed a daily questionnaire on minor stressful events (Daily Stress Inventory, Brantley & Jones, 1989). Patients also indicated their overall level of pain intensity using the short form of the McGill Pain Questionnaire (Melzack, 1987) before and after treatment. We included secondary measures of somatic symptoms through the use of physician global ratings and patient global ratings (see Section ‘‘Post-treatment assessment’’) in order to have data comparable to that presented in other recent RCTs. Thus, we received independent ratings of IBS symptoms from the study gastroenterologists. These were repeated approximately 2 weeks after treatment with the physicians being unaware of the treatment condition to which patients were allocated.

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Post-treatment assessment Participants were interviewed by independent evaluators approximately 2 weeks after the last treatment session. Changes in global status of GI symptoms, overall functioning and side effects (increase in physical symptoms or psychopathology attributable to treatment condition) were assessed by having patients complete global ratings of IBS symptom changes (where, +100 ¼ completely improved to 100 ¼ completely worse) as well as individual GI symptoms (change in pain and change in bowel habit such as diarrhea and/or constipation). The patient also made ratings of changes in sense of well-being. As described above, participants completed two weeks of daily GI symptom diaries. Participants from the Symptom Monitoring Condition were given appointments to begin treatment with the next available cognitive-therapy group. Participants underwent a brief examination by study gastroenterologists, who remained unaware of treatment condition; at which time the physician ratings of patient symptom severity were repeated. Three-month follow-up assessment At the 3-month point, all of the procedures for the post-treatment assessment, except the patient global ratings and physician global ratings, were completed again. The global ratings were not repeated since they were not a primary endpoint. The group members had a short reunion meeting with the therapist and were reminded to continue to apply the procedures they had learned during the formal phase of treatment. They had been sent 2 weeks of GI Symptom Diaries to complete prior to assessment. Treatment Both treatment conditions were applied in small groups of 3–6 participants for ten weekly 90-min sessions. In Albany, the therapists was either Annette Payne, a very experienced clinical psychologist, who helped to develop the CT protocol and who was responsible for developing the Psychoeducational support protocol, or one of three different post-doctoral fellows who had been trained in the procedures by Dr. Payne. In Buffalo, the majority of groups were run by one of two experienced clinical psychologists, Jeffrey M. Lackner or Susan S. Krasner, both of whom had several years of experience treating chronic pain syndromes with cognitive and behavioral techniques. A post-doctoral fellow treated a portion of the Buffalo patients. Cognitive therapy The CT was manualized and is available in Blanchard (2001). In essence it begins with explaining the possible role of stress in IBS symptoms. Participants are taught to become progressively more astute observers of their cognitions by keeping diaries. The initial focus is on becoming aware of ‘‘self-talk’’ (Meichenbaum, 1977) and learning to alter it. Next, attention is directed to Beck’s (1976) ideas of cognitive fallacies (such as all-or-nothing thinking) and how they are applicable to participants. Next, comes attention to underlying schema and an attempt to change maladaptive core beliefs (e.g., perfectionism) that maintain negative thoughts. The cognitive treatment also placed emphasis on problem solving. Participants kept diaries of selftalk and various encounters with stressful situations as part of their homework along with details of efforts to change or counter cognitions. Psychoeducational support This condition was also manualized and available in Blanchard (2001). A series of educational topics are introduced by the therapist, such as diet and food sensitivities, types of diagnostic tests, experience with physicians, etc. The major emphasis of each session was for members to share their views and experiences in an open and accepting manner while being supportive of other group members. The therapist refrained from expressing direct recommendations on any of the topics or from prescribing behavioral or cognitive changes, and ensured that all group members participated. Symptom and stressful event monitoring In this condition participants were asked to continue monitoring their GI symptoms and minor stressful events on a daily basis for 10 weeks. They were seen once at the mid-point to maintain contact. After the posttreatment assessment they were crossed over to the CT condition as soon as a group was available.

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Treatment integrity and process data collection To monitor implementation of both conditions, facilitate consistency of treatment quality and delivery, and prevent therapist ‘‘drift’’ during the study, a doctoral student in clinical psychology sat in on all groups as an observer (not a co-therapist). This individual was responsible for gathering GI symptom diaries and a set of weekly process measures that are not a part of this report. He or she also recorded whether certain tasks and topics, scheduled for that session by the manual, were completed or not. This was our measure of treatment integrity. There was no evidence of compromised treatment delivery. Data analysis The primary analyses are two-way ANOVAs (Site  Treatment Condition), with follow-up pairwise comparisons of treatment conditions with Bonferroni corrections, on a composite measure of GI symptom reduction. Composition symptom diary measure In accordance with all of our previous treatment studies of IBS, in order to reduce the primary hypothesis testing to a single analysis, and thus reduce the possibility of Type I error, we initially calculated a Composite Primary Symptom Reduction (CPSR) score (Blanchard & Schwarz, 1988), for each participant that served as a global measure of symptom relief in accordance with Rome II guidelines. The CPSR was derived using the following formulas: CPSR ¼

SRS pain and tenderness þ SRS bloating þ SRS diarrhea þ SRS constipation , 4ðor 3; depending upon whether diarrhea or constipation or both were presentÞ

where SRS (symptom reduction score) was calculated for each primary GI symptom using the formula: SRS bloating ¼

Pretreatment average bloating  Posttreatment average bloating , Pretreatment average bloating

etc. This composite score assumes reductions in any primary GI symptom are of equivalent value. It ranges from +1.0 (complete remission) to 1.0 (100% worse) by convention. Individual GI symptoms from daily diary The first set of secondary analyses was on the seven1 GI symptoms assessed by the daily diary and the McGill Pain Questionnaires. We conducted an initial MANOVA across a family of measures (e.g. individual GI symptoms from the daily diary) followed as appropriate by 3-way MANOVAs (Treatment Condition  Site  Pre–Post) on each individual measure. As appropriate, these were followed by ANCOVAs on post-treatment scores with pre-treatment scores as the covariate. These were followed by pairwise comparison of treatment conditions. To balance the large number of analyses with a desire to provide maximum information, we report any analysis which reaches the p ¼ 0.05 level, uncorrected. A similar secondary analysis was calculated on physician global ratings. For patient global ratings at the end of treatment, the secondary analysis was a Site  Treatment Condition ANOVA with follow-up comparisons. All of these analyses were conducted on the treatment completer sample (Table 2). Three-month follow-up analyses For these analyses we have combined the data of those who initially received CT with that of those who received CT as a crossover treatment. Thus, the Treatment Condition variable now has only two levels. Data used in these analyses were repeated measures MANOVAs (Condition  Site  Time of Assessment) on the 7 GI symptoms from the daily diary and the McGill Pain Questionnaire. Global ratings by patients or physicians were not collected. The MANOVA was followed by univariate repeated measure ANOVAs with appropriate follow-up tests on variables for which there was a time effect. 1

Although abdominal pain and abdominal tenderness were monitored separately, the values from these two have, by convention, been combined in all tables and analyses.

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Results As is obvious from the above description, this was a somewhat large study made complex by the variety of dependent variables. Change in the wide array of GI symptoms associated with IBS was our primary focus since the other recent RCTs found little in the way of differential somatic symptom improvement. Pre– post change in gastrointestinal symptoms Table 3 shows the CPSR scores for each treatment condition at each site, both for the intent to treat analyses (upper part of Table 3) and for the treatment completer analyses. They represent our primary variables for hypothesis testing. Intent to treat analysis For the 22 patients who were randomized to a treatment condition (see Table 2) but who failed to complete it, we have calculated CPSR scores based on the last available week of symptom diary data as the postmeasure. These values were subjected to a two-way ANOVA (Site  Treatment Condition) that yielded a main effect of treatment (F [2,201] ¼ 4.46, p ¼ 0.013, Z2 ¼ 0.042) with no effect of site or interaction. Follow-up pairwise comparisons of treatment conditions with Bonferroni correction showed CT (p ¼ 0.034) and Psychoeducational Support (p ¼ 0.003) both significantly more improved than Symptom Monitoring with no difference between CT and Psychoeducational Support. Treatment completer analysis These values from the lower half of Table 3 were also subjected to a two-way ANOVA (Site  Treatment Condition) that yielded a main effect of Treatment (F[2,179] ¼ 4.31, p ¼ 00.029, Z2 ¼ 0.046) with no main effect of Site or interaction. Follow-up pairwise contrasts with Bonferroni correction revealed that the value for CT was of borderline significance compared to Symptom Monitoring (p ¼ 0.05), indicating more GI symptom reduction, as was the value for Psychoeducational Support condition (p ¼ 0.003). Again, CT and Psychoeducational Support did not differ. Pre-treatment expectancy measures We compared the composite measure of pre-treatment expectancy of benefit using an adaptation of the treatment credibility/expectancy questionnaire of Borkovec and Nau (1972) across the 2 treatment conditions (CT and Psychoeducational Support) and across the 2 sites. There was no main effect of treatment condition, Table 3 composite primary symptom reduction scores for each treatment condition at each site: intent to treat and treatment completer Sites

Condition Cognitive therapy

Psychoeducational support

Symptom monitoring

Intent to treat Albany Buffalo Combined

0.090 (0.53) 0.163 (0.40) 0.132 (0.44)a

0.255 (0.32) 0.249 (0.46) 0.246 (0.40)a

0.053 (0.53) 0.001 (0.41) 0.038 (0.45)b

Treatment completer Albany Buffalo Combined

0.091 (0.55) 0.159 (0.41) 0.138 (0.44)a

0.249 (0.36) 0.306 (0.38) 0.280 (0.37)a

0.037 (0.57) 0.107 (0.43) 0.075 (0.49)b

CPSR ¼

SRSðPainÞ þ SRSðBloatingÞ þ SRSðDiarrheaÞ þ SRS ConstipationÞ 3 or 4

Note: Combined values which share a superscript do not differ at p ¼ 0.05 or better.

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site or their interaction. The overall mean values (out of a possible 9) were 7.0 (1.5) for CT and 6.8 (1.8) for the Psychoeducational Support Group, p ¼ 0.410. Thus, the two treatments were both seen as credible treatments. Therapist effects We analyzed CPSR scores for possible differential outcome for different therapists (who had differing levels of experience with CT and treatment of pain). There were no significant effects attributable to therapists. Individual GI symptoms Turning to our first secondary analysis, individual GI symptoms from the daily diary, the mean symptom values for baseline and post-treatment for each treatment at each site are presented in Table 4. There were no significant main effects of site or significant interactions with it. There were significant decreases from pre-treatment to post-treatment for abdominal pain and tenderness (po0.001, Z2 ¼ 0.156), Table 4 Mean patients diary ratings of gastrointestinal symptoms and McGill pain questionnaire rating by treatment condition and by site for pretreatment and post-treatment Symptom

Abdominal pain and tenderness

Site

Albany Buffalo

Bloating

Albany Buffalo

Diarrhea

Albany Buffalo

Constipation

Albany Buffalo

Flatulence

Albany Buffalo

Belching

Albany Buffalo

Nausea

Albany Buffalo

McGill pain questionnaire

Albany Buffalo

Pre–Post

Treatment condition Cognitive therapy

Psychoeducational support

Symptom monitoring

Pre Post Pre Post

2.41 1.61 2.30 1.80

(1.3) (1.4) (1.4) (1.5)

1.85 1.25 2.12 1.52

(1.1) (1.4) (1.1) (1.3)

1.47 1.35 2.34 2.19

(0.6) (1.0) (1.5) (1.5)

Pre Post Pre Post

1.52 1.16 1.30 1.10

(0.8) (0.9) (1.0) (0.9)

1.16 1.05 1.35 0.87

(0.8) (0.9) (0.7) (0.8)

0.84 0.79 1.18 1.13

(0.8) (0.8) (0.7) (0.8)

Pre Post Pre Post

0.63 0.51 0.59 0.41

(0.7) (0.6) (0.6) (0.5)

0.76 0.50 0.71 0.63

(0.7) (0.7) (0.6) (0.6)

0.55 0.59 0.94 0.84

(0.6) (0.7) (0.8) (0.8)

Pre Post Pre Post

0.76 0.62 0.60 0.48

(0.7) (0.7) (0.7) (0.6)

0.60 0.59 0.64 0.30

(0.7) (0.7) (0.7) (0.4)

0.72 0.64 0.52 0.51

(0.8) (0.8) (0.6) (0.6)

Pre Post Pre Post

1.45 1.23 1.16 0.89

(0.7) (0.8) (0.7) (0.7)

1.41 1.06 1.25 1.06

(0.7) (0.6) (0.6) (0.8)

1.06 0.95 1.35 1.46

(0.7) (0.6) (0.5) (0.7)

Pre Post Pre Post

0.89 0.76 0.59 0.48

(0.7) (0.8) (0.7) (0.7)

0.59 0.47 0.48 0.45

(0.7) (0.6) (0.5) (0.6)

0.67 0.59 0.67 0.47

(0.8) (0.7) (0.6) (0.6)

Pre Post Pre Post

0.50 0.25 0.48 0.40

(0.6) (0.4) (0.6) (0.6)

0.41 0.27 0.27 0.25

(0.5) (0.7) (0.3) (0.5)

0.19 0.14 0.34 0.43

(0.3) (0.2) (0.5) (0.6)

Pre Post Pre Post

14.6 13.4 17.0 11.3

(10.0) (10.1) (9.7) (7.7)

11.8 9.5 15.1 10.4

(5.7) (7.3) (9.6) (7.2)

8.7 5.6 13.4 9.3

(5.9) (4.2) (7.2) (7.8)

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bloating (po0.001, Z2 ¼ 0.108), diarrhea (p ¼ 0.004, Z2 ¼ 0.046), constipation (po0.005, Z2 ¼ 0.043), flatulence (po0.001, Z2 ¼ 0.093), belching (p ¼ 0.006, Z2 ¼ 0.044), and nausea (p ¼ 0.048, Z2 ¼ 0.023). There were Pre–Post  Treatment Condition interactions for pain (F[2,179] ¼ 3.98, p ¼ 0.020, Z2 ¼ 0.043), bloating (F[2,179] ¼ 3.35, p ¼ 0.037, Z2 ¼ 0.036) and flatulence (F[2,168] ¼ 3.74, p ¼ 0.026, Z2 ¼ 0.043). The Pre–Post  Treatment Condition interactions were followed up with ANCOVAs on post-test scores with the pre-treatment score as the covariate and then pairwise comparisons. These follow-up analyses revealed significantly greater reductions in pain and tenderness for CT versus Symptom Monitoring (p ¼ 0.035) and Psychoeducational Support versus Symptom Monitoring (p ¼ 0.034), with no difference between the two treatments. A similar pattern emerges for flatulence with both the CT (p ¼ 0.002) and Psychoeducational Support (p ¼ 0.018) showing a greater reduction than Symptom Monitoring. Again, the two treatments did not differ. For bloating there was a trend (p ¼ 0.07) for CT to show a greater reduction than Symptom Monitoring. No other pairwise comparisons approached significance.

McGill Pain Questionnaire (MPQ) A similar 3-way ANOVA on the MPQ likewise yielded only a main effect of Pre–Post (F[1,129] ¼ 12.16, p ¼ 0.001) with no other main effects or interactions. For this measure the mean score decreased from 15.0 to 10.7, across all conditions at both sites.

Patient global ratings In Table 5 are the mean values for the patients’ three end of treatment global ratings on changes in GI symptoms as well as the rating of change in sense of well-being, tabulated by treatment condition at each site. There was a significant overall effect of Treatment Condition (F[2,140] ¼ 5.21, p ¼ 0.007, Z2 ¼ 0.069), Site (F[2,140] ¼ 5.83, p ¼ 0.017, Z2 ¼ 0.040), and a Treatment  Site interaction (F[2,140] ¼ 3.43, p ¼ 0.035, Z2 ¼ 0.047). The follow-up analyses revealed main effects of Treatment Condition for Overall Change in GI Symptoms (p ¼ 0.004, Z2 ¼ 0.066), Change in Pain (p ¼ 0.045, Z2 ¼ 0.037), and Change in Bowel Regularity (p ¼ 0.009, Z2 ¼ 0.064). In all three instances, pairwise comparisons showed significantly greater ratings of change for CT than Symptom Monitoring (overall GI, p ¼ 0.002; pain, p ¼ 0.018; regularity, p ¼ 0.003), with no difference between CT and Psychoeducational Support. For change in regularity, Psychoeducational Support was superior to Symptom Monitoring (p ¼ 0.014). Albany patients had significantly higher ratings overall than Buffalo patients on Change in Pain (p ¼ 0.023, Z2 ¼ 0.032) and Overall Change in GI Symptoms (p ¼ 0.037, Z2 ¼ 0.026).

Table 5 Patient global ratings of change as function of site and treatment condition Variable rated

Site

Treatment condition Cognitive therapy

Psychoeducational support

Symptom monitoring

Overall change in GI symptoms

Albany Buffalo

50.0 (29.9) 53.9 (34.2)

48.8 (50.0) 28.0 (32.0)

38.9 (34.4) 14.6 (37.4)

Overall change in pain

Albany Buffalo

42.9 (33.6) 44.4 (37.1)

38.7 (49.8) 27.3 (33.8)

42.8 (42.2) 5.1 (33.5)

Overall change in bowel regularity

Albany Buffalo

40.3 (34.0) 44.6 (34.9)

57.0 (36.6) 28.9 (35.7)

23.0 (25.1) 9.8 (32.3)

Overall change in sense of well-being

Albany Buffalo

47.2 (35.9) 54.0 (31.1)

63.9 (35.7) 36.4 (35.9)

38.4 (40.8) 22.2 (35.7)

Note: The higher the score, the greater the perceived change.

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Table 6 Physician rating of IBS symptoms before and after treatment for each treatment condition Rating

Time

Treatment condition Cognitive therapy

Psychoeducational support

Symptom monitoring

Overall IBS symptoms

Pre Post

5.8 (1.0) 4.4 (1.4)***

6.0 (1.2) 4.9 (1.5)**

6.0 (1.2) 5.0 (1.8)*

Abdominal pain and tenderness

Pre Post

5.3 (1.6) 4.2 (1.5)***

5.2 (1.8) 4.0 (1.9)**

5.6 (1.0) 4.4 (1.6)**

Diarrhea and/or constipation

Pre Post

5.4 (1.6) 4.4 (1.6)***

6.0 (1.3) 5.0 (1.4)*

5.6 (1.2) 5.1 (1.6)

Bloating

Pre Post

5.0 (1.9) 4.1 (2.1)**

5.0 (2.6) 4.3 (2.3)

4.1 (2.5) 3.7 (2.3)

Note: Within group change is significant at *po0.05, **po0.01, ***po0.001.

Patient global rating of change in sense of well-being The end of treatment rating of change in sense of well-being (Table 5) could be seen as a quality of life measure. Pairwise comparisons showed greater (p ¼ 0.018) change in CT than Symptom Monitoring with Psychoeducational Support between the two and not different from the either other treatment. Physician ratings In Table 6 are the physician ratings of GI symptoms for combined frequency and intensity for patients in each treatment condition. The post-treatment ratings were blinded to treatment condition. There were significant (po0.001) Pre–Post main effects for overall IBS symptoms, abdominal pain, and diarrhea/constipation, but not for bloating. There were no main effects of Treatment Condition, Site, or significant interactions. For information purposes, within group correlated t-tests were calculated on each rating for each treatment. These results are also in Table 6. Cross-over treatment of symptom monitoring controls At the conclusion of 10 weeks of GI symptom and daily stress monitoring, these 39 controls were crossed over to receive CT; 35 completed treatment, whereas 4 declined or dropped out. At the conclusion of the CT, these crossover participants again monitored GI symptoms for 2 weeks and completed the global ratings of change. Data from these participants were analyzed in two ways: first, they were subjected to a one-way ANOVA across the 3 assessments with follow-up tests to determine if their post-CT scores were different from pre- and/or post-symptom monitoring. Second, their post-CT scores were compared to the values from those who received CT initially to see if the two samples could be legitimately merged. There were significant effects of Time of Assessment for diarrhea (Pre-Monitor: 0.74; Post-Monitor: 0.73; Post-treatment: 0.58; F[2,72] ¼ 4.92, p ¼ 0.013), belching (Pre-Monitor: 0.61; Post-Monitor: 0.48; PostTreatment: 0.32; F[2,68] ¼ 9.48, po0.001) and the McGill Pain Questionnaire (Pre-Monitor: 12.7; PostMonitor: 8.6; Post-Treatment: 9.9; F[2,48] ¼ 5.20, p ¼ 0.001). Follow-up comparisons reveal three different patterns of significant (p ¼ 0.05 or better) changes: for belching, there was a significant change from pretreatment to post-symptom monitoring with a further significant change from post-monitoring to post-CT. There was no pre-treatment to post-monitoring change for diarrhea, but significant reduction after treatment with CT. Finally, for the McGill Pain Questionnaire; there was a significant change from pre-treatment to post-monitoring with no further change with active treatment. For the global patient ratings of change, there were significant (p ¼ 0.01 or better) changes from post-monitoring to post-CT for all three ratings of

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IBS-related problems. The post-CT values were not different for these crossover patients from the mean values of those who received CT initially. Three-month follow-up results It is of some interest that we lost only 13 patients of 188 (6.9%) between the end of treatment and 3-month follow-up. One was from Psychoeducational Support and 12 were from CT, including one cross-over patient, and included 10 women and 3 men, of average age 40.9 years who had had IBS for 10.0 years. In Table 7 are the mean values for each treatment condition, as well as for the two treatments combined, at the three assessment points, pre-treatment, post-treatment and 3-month follow-up. Table 7 also includes the McGill Pain Questionnaire for the same points. All eight measures showed significant (p ¼ 0.018 or better) main effects of Time of Assessment with no other main effects or interactions. Two patterns of change emerged. For abdominal pain and tenderness, bloating, and flatulence, there was a significant change from pre-treatment to post-treatment and further significant changes from post-treatment to follow-up. For the other variables, diarrhea, constipation, belching, nausea and McGill Pain Questionnaire, there was also significant improvement from pre-treatment to post-treatment, but the change from post-treatment to follow-up was not significant. There were no instances of differential improvement by one treatment condition or the other, nor any instances of site accounting for significant variance.

Table 7 GI symptom diary and McGill pain questionnaire mean values for each condition at pre-treatment, post-treatment and 3-month follow-up Measure

Overall

Treatment

Time of assessment

p

Condition

Pre-Tx.

Post-Tx.

3-Mo. FU

o0.001

Cognitive therapy Psychoeducational Combined Tx

2.22 (1.40) 2.04 (1.07) 2.18 (1.32)a

1.75 (1.40) 1.42 (1.35) 1.67 (1.39)b

1.47 (1.31) 1.17 (1.27) 1.41c

o0.001

Cognitive therapy Psychoeducational Combined Tx

1.26 (0.91) 1.28 (0.75) 1.27 (0.88)a

1.09 (0.91) 0.95 (0.86) 1.06 (0.90)b

0.90 (0.82) 0.84 (0.87) 0.89c

0.002

Cognitive therapy Psychoeducational Combined Tx

0.62 (0.64) 0.74 (0.65) 0.65 (0.64)a

0.48 (0.55) 0.58 (0.67) 0.50 (0.57)b

0.44 (0.56) 0.62 (0.72) 0.48b

0.001

Cognitive therapy Psychoeducational Combined Tx

0.64 (0.70) 0.64 (0.67) 0.64 (0.69)a

0.56 (0.66) 0.44 (0.58) 0.53 (0.64)b

0.49 (0.67) 0.39 (0.57) 0.46b

o0.001

Cognitive therapy Psychoeducational Combined Tx

1.26 (0.67) 1.34 (0.64) 1.28 (0.66)a

1.05 (0.73) 1.09 (0.72) 1.05 (0.73)b

0.89 (0.69) 0.96 (0.74) 0.90c

0.003

Cognitive therapy Psychoeducational Combined Tx

0.65 (0.67) 0.57 (0.59) 0.63 (0.65)a

0.51 (0.71) 0.50 (0.60) 0.51 (0.69)b

0.45 (0.65) 0.39 (0.44) 0.43b

0.018

Cognitive therapy Psychoeducational Combined Tx

0.44 (0.58) 0.33 (0.40) 0.42 (0.55)a

0.33 (0.50) 0.24 (0.56) 0.31 (0.51)b

0.35 (0.60) 0.15 (0.29) 0.31b

0.003

Cognitive therapy Psychoeducational Combined Tx

16.4 (9.8) 14.0 (8.9) 15.9 (9.6)a

11.8 (8.4) 10.4 (7.1) 11.5 (8.1)b

11.0 (8.6) 11.7 (7.5) 11.2 (8.3)b

Abdominal pain and tenderness

Bloating

Diarrhea

Constipation

Flatulence

Belching

Nausea

McGill Pain Questionnaire

Note: Combined treatment means in a row that share a superscript do not differ at p ¼ 0.05 or better.

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Discussion This is a large and complex set of results, in large part because different methods of assessing outcome yield somewhat different patterns of results, and in part because of the multisymptomatic nature of IBS. Turning first to somatic symptoms, the reason patients seek treatment, on our most conservative and global measure, the CPSR from patient daily GI symptom diaries, the intent to treat analysis showed the group CT was superior to the intensive symptom monitoring but was not different from the Psychoeducational Support groups. Among the treatment completers, the same pattern is found where group CT and Psychoeducational Support are both superior to Symptom Monitoring but group CT is not different from Psychoeducational Support. This pattern of results parallels daily monitoring scores on the individual GI symptoms such as abdominal pain and flatulence, CT and Psychoeducational Support were both superior to Symptom Monitoring. On bloating, there was a trend for CT to be superior to Symptom Monitoring. Group CT was not different than Psychoeducational Support groups on any individual symptom. From these daily symptom based findings we may tentatively conclude three things: (1) systematic psychological treatment in a small group format is reliably superior to enhanced symptom monitoring; (2) the symptomatic effects of group CT are not reliably different than those found in a credible control condition of similar format, Psychoeducational Support groups. This latter finding has at least two explanations: (i) a group form of CT is no more effective than a credible attention placebo control condition or (ii) Psychoeducational Support groups are an active treatment (it is superior to enhanced symptom monitoring) that is equivalent to group CT; (3) There were no differences attributable to treatment site. When we turn to our secondary outcome measures, that is, various global ratings or other global measures which were included to provide information comparable to that reported in recent psychosocial RCTs for IBS, a somewhat different pattern of results emerge. CT is statistically superior to Symptom Monitoring on all three patient global ratings, whereas Psychoeducational Support was superior to Symptom Monitoring only on overall improvement in regularity. There were no differences between CT and Psychoeducational Support. Physician global ratings, completed after treatment in a blind and independent fashion, reveal improvement by about 20–25% for each of the three conditions, but no differential effect among the three conditions. The McGill Pain Questionnaire yielded similar results. Finally, on a post-treatment measure of quality of life, patient ratings of global change in overall well-being, patients in CT demonstrated greater improvement than patients in Symptom Monitoring with those in the Psychoeducational Support condition in between the two other conditions and not different than either of them. These secondary measures lead to a slightly different set of tentative conclusions: (1) Group CT is again not reliably different from the credible control condition of Psychoeducational Support groups; (2) on patient global ratings of symptomatic improvement and quality of life, group CT is superior to intensive symptom monitoring, whereas (2A) Psychoeducational Support groups are not superior to symptom monitoring for the most part; (3) on physician global ratings and McGill Pain Questionnaire, the three conditions all improve with no significant differential effect. It thus seems clear that one can find different patterns of results depending upon the outcome measures used. This adds to the complexity of the field and its treatment outcome literature. It also seems a topic in need of more research. When we crossed over the patients from Symptom Monitoring to CT, they showed significant improvement on some GI symptoms, possibly speaking to the potency of gut-specific CT (as opposed to general stress management approaches) on IBS symptoms. In other words, the CT condition conferred an added therapeutic value over and above that associated with enhanced symptom monitoring alone. Our one previous evaluation of the Psychoeducational Support groups (Payne & Blanchard, 1995) found it significantly less efficacious than individually administered CT. The current lack of difference thus may arise because group administered CT is not as effective as the individually administered version. Certainly, the average CPSR scores from the current study and those studies that used individual CT (Greene & Blanchard, 1994, Payne & Blanchard, 1995, Vollmer & Blanchard, 1998) point in this direction. We thus return to our second conclusion, that group CT and Psychoeducational Support groups yield essentially equivalent outcomes, as they are not statistically different on any variable. There are at least two

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possible reasons for this equivalence. First, the active therapeutic elements in both treatments might be the same. That is, both treatments involved a series of meetings with a small group of individuals with similar problems, facilitated by a warm, supportive leader. Learning that others had similar problems and similar thoughts could be therapeutic. It is also possible that the dissemination of more accurate information regarding IBS, whether through structured, formal cognitive restructuring or through more informal clientdriven channels effectively challenges and disputes negative beliefs that play a strong role in the expression and maintenance of IBS (Drossman, Li, et al., 2000; Drossman, Patrick et al., 2000; Lackner, Quigley, & Blanchard, 2004). An alternative explanation is that each treatment contains unique active therapeutic elements and that they both help IBS patients but by different means. We do not have the data to choose between these alternatives. Comparing our results to those summarized in the Introduction, we found consistent improvement in GI symptoms, especially the symptoms of pain and discomfort. These findings improve upon the findings of Drossman et al.’s (2003) CBT, Creed et al.’s (2003) interpersonal therapy or Boyce et al.’s (2003) CBT. We also found noticeable improvement in global ratings of GI symptoms, whether measured by the patient or the physician, in a pattern that generally paralleled outcome data from the symptom diaries. The 3-month follow-up data are very heartening. There is either stability of initial improvement (e.g. diary ratings of diarrhea and constipation) or additional improvement (e.g. diary ratings of pain and tenderness, and of bloating) on all variables. Limitations Interestingly, we did not achieve the level of GI symptom reduction we had seen in earlier small studies of individually administered CT; we saw only less than half of the composite symptom reduction that we had seen in our prior studies. Thus a clear limitation of the study was our failure to include an individually administered CT condition. The reason for the poorer overall results could be related to the difference in method of delivering the CT (individual CT in earlier studies versus group CT in the current study). The lower level of composite symptom reduction could also be because the current population was noticeably older (49 versus 39) and more chronic (19 years IBS symptoms versus 14 years). We do know from physician ratings that this was overwhelmingly (97%) a moderate to very severely affected population. We did not have pre-treatment physician severity ratings in previous studies, so a comparison is not possible. We had a very small minority population (5%) despite repeated recruitment efforts. This limits generalizability. Unlike other studies that have recruited only female patients, our sample included both male and female sufferers of IBS. While we would have preferred a larger male sub-sample, our data argue against the conventional wisdom that the therapeutic value of the treatments is reserved for female patients only. A further limitation could be the psychometric properties of our primary dependent variable, the CPSR. It is an average of 3 or 4% improvement scores for different symptoms and thus treats percent improvement in each symptom as numerically equivalent. However, this measure has served us well in eight previous studies over 20 years. Moreover, the results it yielded, no difference between CT and Psychoeducational Support with both being superior to Symptom Monitoring, were replicated by individual GI symptoms. Because our primary results are based on patients who completed treatment, our data may paint a biased picture of the clinical efficacy of psychological treatments. As it is, 25% discontinued participation during the initial assessment and 4-week baseline symptom-monitoring phase. Moreover, 10% of those randomized to treatment, who attended at least one group treatment session, dropped out before completing treatment. The dropouts tended to be less chronic and more likely to have an Axis I diagnoses. Our dropout rates, however, are comparable to those of Drossman et al. (2003) and noticeably superior to those of Boyce et al. (2003). Longer-term follow-up is clearly needed as well as evaluation of cost-effectiveness as shown by Creed et al. (2003). Despite these limitations, we are encouraged by the results of a study whose design largely overcomes many of the methodological limitations that have obscured the interpretability of previous psychological trials (see Lackner et al., 2004). Unlike investigators of other recent large-scale RCTs, we were able to demonstrate that psychological interventions not only relieve symptoms of IBS, especially abdominal pain and discomfort, but

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their therapeutic effect is maintained (if not improved upon) at least 3 months post-treatment. Moreover, we were able to successfully export the Albany CT and Psychoeducational Support groups to a second site without allegiance to the featured interventions. Acknowledgements This research was supported by a Grant from NIDDK, DK-54211. Requests for further information may be sent to Dr. Blanchard at 72 Old Route 66, Averill Park, NY 12018. The authors wish to acknowledge the assistance in Albany, of Drs. Janine Walsh, Elizabeth Mundy and Tara Galovski who served as post-doctoral fellows and treated patients in Albany, and of Dr. Howard Malamood and of Albany Gastroenterology Associates who provided pre-treatment examinations of patients. In Buffalo, we acknowledge the valuable contributions of Drs. Sally Norman, Rebecca Gellman and Peter Lance.

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