A randomized-controlled trial of an early minimal cognitive-behavioural therapy for insomnia comorbid with cancer

Behaviour Research and Therapy 67 (2015) 45e54

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A randomized-controlled trial of an early minimal cognitivebehavioural therapy for insomnia comorbid with cancer*
e Savard a, b, *, Hans Ivers a, b, Marie-He
le ne Savard b Lucie Casault a, b, c, Jose School of Psychology, Universit
e Laval, Qu
ebec, Qu
ebec, G1V 0A6, Canada ^te du Palais, Qu
Centre de recherche du CHU de Qu
ebec and Centre de recherche sur le cancer, Universit
e Laval, 11 Co ebec, G1R 2J6, Canada c ^te du Palais, Qu
Centre hospitalier universitaire (CHU) de Qu
ebec, 11, Co ebec, Qu
ebec, G1R 2J6, Canada a

b

a r t i c l e i n f o

a b s t r a c t

Article history: Received 11 July 2014 Received in revised form 13 January 2015 Accepted 23 February 2015 Available online 25 February 2015

Objective: This study aimed to provide preliminary evidence on the efficacy of an early minimal cognitive-behavioural therapy for acute insomnia (mCBT-I) comorbid with cancer. Method: Thirty-eight patients (92% female; Mage 57; all Caucasian) with various types of cancer and having insomnia symptoms for less than 6 months were randomized to a self-administered mCBT-I condition (n ¼ 20; 6 short booklets þ 3 phone consultations with a psychologist, over 6 weeks) or a notreatment condition (n ¼ 18). Measures were completed at pre-treatment and post-treatment, as well as at 3- and 6-month follow-ups. Results: All sleep parameters and the average dosage of hypnotics were significantly improved from preto post-treatment among treated participants, but not in control participants. mCBT-I was also associated with a significantly greater reduction of anxiety and depression symptoms, maladaptive sleep habits, and erroneous beliefs about sleep, as well as with a significantly greater improvement of subjective cognitive functioning. A greater proportion of mCBT-I participants than controls met the criteria for a clinical remission at post-treatment. Therapeutic gains of mCBT-I were well sustained up to 6 months after the intervention. Conclusions: This study supports the efficacy of an early minimal CBT-I to treat acute insomnia comorbid with cancer. © 2015 Elsevier Ltd. All rights reserved.

Keywords: Cancer Insomnia Acute Cognitive-behavioural therapy Early minimal intervention

Insomnia is highly prevalent among individuals with cancer. Rates of insomnia found in cancer patients are two to three times higher than in the general population (Morin, LeBlanc, Daley, Gregoire, & Merette, 2006; Ohayon, 2002). A population-based longitudinal study (n ¼ 991) conducted by our research team showed that as many as 59% of cancer patients report insomnia symptoms during the peri-operative period (Savard, Villa, Ivers, Simard, & Morin, 2009). While the prevalence of insomnia generally declined over time, 36% of patients continued to experience insomnia at the 18-month follow-up (Savard, Ivers, Villa, CapletteGingras, & Morin, 2011). Insomnia, especially when it becomes chronic, is associated with several daytime sequelae, including fatigue (Lichstein, Means,

*
bec and This study was conducted at the Centre de recherche du CHU de Que
Laval Que
bec, Que
bec, Canada. Centre de recherche sur le cancer, Universite ^ te du * Corresponding author. Laval University Cancer Research Center, 11 Co
bec, Que
bec, G1R 2J6, Canada. Palais, Que E-mail address: [email protected] (J. Savard).

http://dx.doi.org/10.1016/j.brat.2015.02.003 0005-7967/© 2015 Elsevier Ltd. All rights reserved.

Noe, & Aguillard, 1997), poor concentration and memory (FortierBrochu, Beaulieu-Bonneau, Ivers, & Morin, 2012), decreased work productivity (Daley, Morin, LeBlanc, Gregoire, & Savard, et al., 2009), and impaired quality of life (Chevalier et al., 1999; Zammit, Weiner, Damato, Sillup, & McMillan, 1999). In the long-term, insomnia may lead to psychological disturbances such as depression, anxiety, and substance use disorders (Breslau, Roth, Rosenthal, & Andreski, 1996; Buysse et al., 2008; Chang, Ford, Mead, Cooper€ jmark & Patrick, & Klag, 1997; Ford & Kamerow, 1989; Jansson-Fro Lindblom, 2008; Morphy, Dunn, Lewis, Boardman, & Croft, 2007; Neckelmann, Mykletun, & Dahl, 2007), and is associated with an increased utilization of health care services and hospitalization
ger, (Daley, Morin, LeBlanc, Gregoire, & Savard, 2009; Le Guilleminault, Bader, Levy, & Paillard, 2002). Despite the significance of their consequences and the fact that they are often a persistent condition in the context of cancer, sleep difficulties are typically overlooked in clinical care. Cognitive-behavioural therapy for insomnia (CBT-I) is now considered the treatment of choice for chronic insomnia with no

46

L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

psychological or medical comorbidity (National Institutes of Health, 2005). One advantage of CBT-I over pharmacotherapy is that it is associated with a larger sustainment of therapeutic gains over time (Morin, Bootzin, et al., 2006; Morin, LeBlanc, et al., 2006). The efficacy of CBT-I for chronic insomnia comorbid with cancer has been supported in several randomized controlled trials (RCT) (Epstein & Dirksen, 2007; Espie et al., 2008; Fiorentino et al., 2009; Garland et al., 2014; Savard, Simard, Ivers, & Morin, 2005). However, a major limitation for the routine implementation of CBT-I in cancer clinics is the scarcity of mental health professionals formally trained in this approach, as well as the costs associated with the treatment sessions. In addition, our experience suggests that the number of CBT-I sessions offered (usually around 6), although not that numerous, is still too demanding for many patients, especially during the active phase of treatment. Thus, a high proportion of cancer patients do not receive any appropriate treatment for their sleep difficulties or are prescribed pharmacotherapy only, which is associated with many side effects, risks, and limitations (Hall, 1998; Morin, 1993, 2001; National Institutes of Health, 2005). Moreover, although it is recommended that individuals limit the duration of their hypnotics use to a period of two to four weeks (National Institutes of Health, 2005), the average duration amounts to several years among cancer patients (Casault, Savard, Ivers, Savard, & Simard, 2012). As an alternative, more minimal forms of CBT-I could be implemented. In the context of insomnia with no comorbidity, minimal therapy (i.e., bibliotherapy, video, television program, web-based therapy) has been found to produce greater effects than a control condition (Currie, Clark, Hodgins, & El-Guebaly, 2004; Espie et al., 2012; Mimeault & Morin, 1999; Morawetz, 1989; Morin, Beaulieu-Bonneau, LeBlanc, & Savard, 2005; Oosterhuis & Klip, 1993; Riedel, Lichstein, & Dwyer, 1995; Ritterband et al., 2009; € m, Pettersson, & Andersson, 2004; van Straten, Cuijpers, Smit, Stro Spermon, & Verbeek, 2009; Vincent & Lewycky, 2009). There is also some evidence suggesting that a self-help CBT-I could be as effective as professionally-administered therapy (Bastien, Morin, Ouellet, Blais, & Bouchard, 2004). However, some research has found that the addition of some form of therapist support improves treatment efficacy (Mimeault & Morin, 1999; Riedel et al., 1995). In the context of cancer, preliminary data (n ¼ 11) have shown that an intervention combining a 60-min video and 6 short booklets was feasible and acceptable by breast cancer patients with insomnia (average insomnia duration: 86 months) (Savard, Villa, Simard, Ivers, & Morin, 2011). These results are consistent with those of Ritterband et al. (2012) in 28 cancer survivors with a diagnosis of chronic insomnia (i.e., 6 months), comparing a web-based CBT-I treatment to a waiting list control condition. The use of minimal interventions would be especially relevant for the management of acute insomnia. CBT-I administered soon following the onset of insomnia symptoms has the potential to prevent sleep difficulties from becoming chronic during the cancer care trajectory. Moreover, an early intervention may help reduce the negative impact of insomnia on patients' quality of life, in addition to limiting its direct and indirect costs. However, the efficacy of such an approach needs to be empirically tested. The main goal of this study was to assess the efficacy of a selfadministered minimal CBT-I (mCBT-I) combining a bibliotherapy with brief phone consultations for the management of acute insomnia comorbid with cancer. Secondary objectives were to assess the effect of this intervention on hypnotic consumption, anxiety, depression, and fatigue symptoms, quality of life, subjective cognitive functioning, maladaptive sleep habits, and erroneous beliefs about sleep. It was expected that, at post-treatment and at the 3- and 6-month follow-ups, participants receiving mCBT-I would show significantly greater improvements in subjective

sleep parameters (sleep diary parameters and ISI score) compared to controls (CTL). It was also expected that treated participants would show a significantly greater reduction of hypnotic consumption, psychological distress, fatigue, maladaptive sleep habits, and erroneous beliefs about sleep, as well as greater increases in quality of life and subjective cognitive functioning. Method Participants Eligibility criteria Inclusion criteria were: (a) a diagnosis of non-metastatic cancer; (b) acute insomnia symptoms (i.e., <6 months) as assessed with the Insomnia Interview Schedule (Morin, 1993); (c) score on the Insomnia Severity Index (ISI; Morin, 1993) of 8 or greater; (d) aged between 18 and 75 years old; and (e) able to readily read and understand French. Exclusion criteria were: (a) regular hypnotic medication usage (i.e., 3 nights per week) for more than 6 months; (b) diagnosed by a physician with or treated for a sleep disorder other than insomnia (e.g., sleep apnea, periodic limb movements); (c) severe cognitive impairments (e.g., Alzheimer's disease) or a comorbid medical condition known to alter sleep (e.g., multiple sclerosis) as noted in the medical chart, observed at recruitment, or reported by the patient; (d) severe psychiatric disorder (e.g., major depressive disorder) as assessed with the Prime-MD (Spitzer et al., 1994); and (e) already involved in a psychotherapy addressing sleep difficulties. Recruitment Most participants were solicited in person between March 2004 and November 2005 at their pre-operative visit to the ambulatory ^tel-Dieu de Que
bec and at the Ho ^ pital du Saintcare unit of L0 Ho
bec). Some other participants were Sacrement (CHU de Que recruited by phone through other studies conducted in our laboratory. The study was approved by the ethics review board of both hospitals and of Laval University. Of the 722 patients approached at the clinics or by phone, 37 refused the screening, and 612 were excluded (see Fig. 1). The main reasons for exclusion were an ISI score <8 (n ¼ 302) and chronic insomnia (i.e., 6 months; n ¼ 187). Of the 73 potentially eligible patients, 27 refused to participate in the study, thus giving a participation rate of 63%. Eight of the 46 patients who accepted to participate in the RCT were excluded following the clinical interview, leaving a total of 38 participants. Three participants in the mCBT-I condition dropped out before completing all pre-treatment measures. Statistical analyses were therefore based on a sample of 35 participants. Three additional participants dropped out of the study at post-treatment and 2 at the 6-month follow-up (3 in the mCBT-I group and 2 in the CTL group). Sample size justification and power analyses Sensitivity power analyses were performed with G*Power 3.1.5 using standard conditions (alpha ¼ 5%, power ¼ 80%), a sample size of 35 participants, 4 time assessments, and an expected dropout rate of 10% per assessment (about 90 df for Time and Group  Time interactions). Under these conditions, an effect size f ¼ 0.21 could be detected (between small ¼ 0.10 and moderate ¼ 0.25; Cohen, 1988). Randomization and allocation concealment The randomization sequence was prepared by a biostatistician using a random permuted-block procedure (SAS 9.3 PROC PLAN) with block sizes varying from 4 to 8 to minimize between-group imbalance during the study. The allocation sequence was

L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

47

18

Fig. 1. Participants' flow chart.

concealed in opaque, sealed envelopes that were numbered in advance and opened sequentially. All research assistants and clinicians were blind to the group allocation sequence.

Study design This study was a 2-group RCT with an allocation ratio of 1:1: (1) mCBT-I (n ¼ 20); and (2) CTL (no CBT-I; n ¼ 18). Participants were assessed at pre- and post-treatment, as well as at 3- and 6-month follow-ups.

Procedure Pre-treatment assessment Consenting and eligible patients were invited to a clinical interview at the research center, conducted by a graduate student in psychology. First, the goals and procedures of the study were explained in detail and participants' written consent was obtained. Then, the Insomnia Interview Schedule (Morin, 1993) was administered in order to screen out patients with a sleep disorder other than insomnia and to gather further information on sleep and hypnotic consumption, as well as the Prime-MD (Spitzer et al., 1994) to screen out patients with severe psychiatric disorders.

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L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

Patients who were still eligible at this point were randomly assigned to either mCBT-I, or to the CTL condition. A battery of questionnaires and a daily sleep diary (14 days) were then completed at home by the participant and mailed back. Minimal CBT-I group The insomnia treatment consisted of a self-help CBT offered in a bibliotherapy format, combined with 3 brief phone consultations. This multimodal approach combined behavioural (i.e., stimulus control therapy, sleep restriction), cognitive (i.e., cognitive restructuring), and educational (i.e., sleep hygiene) strategies that were explained in the patients' booklets. Participants were asked to read one booklet of approximately 10e15 pages each week. They were also asked to complete a quiz after each booklet had been read in order to verify their level of understanding of the information provided. The content of the booklets was divided as follows: (1) basic sleep facts; (2) stimulus control and sleep restriction; (3) hypnotic usage, benefits and risks of chronic use; cessation program for participants wishing to stop their hypnotic medication under the supervision of their pharmacist or physician; (4) cognitive restructuring of dysfunctional beliefs and attitudes about sleep and hypnotic use; (5) sleep hygiene; and (6) progress assessment, learning retention, and relapse prevention. The content of the manual was based on the ones developed by Morin (1993), and Mimeault and Morin (1999) for primary insomnia, and from the ones developed by Quesnel, Savard, Simard, Ivers, and Morin (2003), and Savard, Simard, et al. (2005) for insomnia comorbid with cancer. Participants were instructed to continue completing the daily sleep diary throughout the treatment for clinical purposes. Phone consultations (max. 30 min each; average duration ¼ 22 min) were administered by a psychologist every two weeks for the purpose of maximizing adherence to treatment procedures and providing professional support to participants, for a total of 3 phone calls. During these structured phone interviews, the psychologist verified the responses to the quiz, corrected some misunderstanding, answered participants' questions, and further explained some basic concepts when needed. The clinician also investigated the extent to which participants adhered to the cognitive and behavioural strategies, and provided them with some suggestions to reinforce compliance when appropriate. Control group (CTL) Participants assigned to the CTL condition did not receive any intervention during the 6-week period. Complimentary CBT-I booklets were offered to them once the 6-month follow-up was completed. Post-treatment and follow-up assessments At the end of the 6-week period, as well as 3 and 6 months later, the participants again completed the battery of self-report scales and a daily sleep diary during 14 days. Participants received a monetary compensation of $20.00 CDN after the completion of each assessment. Measures All FrencheCanadian versions of measures used have been empirically validated or developed by the authors of the original version. Insomnia Interview Schedule (IIS; Morin, 1993) The IIS is a semi-structured interview that gathers a wide range of information about the nature and severity of the sleep problem. The IIS also assesses the duration of insomnia, past and current use of sleeping aids (i.e., prescribed and over-the-counter medications,

alcohol), as well as symptoms of other sleep disorders for differential diagnosis. Insomnia Severity Index (ISI; Morin, 1993) The ISI includes seven items which evaluate, for the previous two weeks, the perceived severity of difficulties falling asleep, difficulties maintaining sleep and early morning awakenings, as well as the degree of dissatisfaction with current sleep, the degree to which sleep difficulties interfere with daytime functioning, the degree to which the deterioration of functioning related to the sleep problem is noticeable by others, and the level of distress or worry caused by the sleep difficulties (rated on a scale from ‘0’ [not at all] to ‘4’ [very much]). The ISI was empirically validated among cancer patients (Savard, Savard, Simard, & Ivers, 2005). A score of 8 or greater is used to detect clinically significant insomnia. Sleep diary The following variables were derived from the sleep diary: sleep onset latency (SOL; time from lights out to sleep onset), number of awakenings, wake after sleep onset (WASO), total wake time (TWT; the sum of all awakenings, from lights out until the last awakening), total sleep time (TST), sleep efficiency (SE; total sleep time divided by total time in bed), and hypnotic usage. Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) This is a 14-item questionnaire divided into two sub-scales: depression (HADS-D: 7 items) and anxiety (HADS-A: 7 items) and rated on a scale from ‘0’ to ‘3’. The HADS contains no somatic items that may be confounded with symptoms of the physical illness (Roth et al., 1998; Savard, Laberge, Gauthier, Ivers, & Bergeron, 1998). Multidimensional Fatigue Inventory (MFI; Smets, Garssen, Bonke, & De Haes, 1995) This questionnaire has been developed to assess fatigue among
linas, Simard, cancer patients. The French-Canadian (Fillion, Ge Savard, & Gagnon, 2003), short form used in this study contains 15 items (rated on a scale from ‘0’ to ‘4’). The global score of fatigue, obtained by averaging all subscales (general and physical fatigue, reduction in activity, reduction in motivation, and mental fatigue), was used. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QOL; Aaronson et al., 1993) Only the cognitive (2 items ranging from ‘1’ [not at all] to ‘4’ [very much]) and global (3 items, ranging from ‘1’ [very bad] to ‘7’ [excellent]) scales were used in this study. Dysfunctional Beliefs and Attitudes about Sleep Scale e Brief version (DBAS; Morin, 1994; Morin, Valli eres, & Ivers, 2007) We used a short form (13 items) of this questionnaire. It evaluates the most common dysfunctional beliefs and attitudes about sleep using a visual analogue scale ranging from ‘0’ (completely disagree) to ‘10’ (completely agree). Four theoretical factors are evaluated: perceived consequences of insomnia, worry/helplessness about insomnia, sleep expectations, and medication. The DBAS has an acceptable internal reliability (Cronbach's alpha ¼ .72; Espie, Inglis, Harvey, & Tessier, 2000) and is sensitive to therapeutic changes (Morin, Blais, & Savard, 2002). Sleep Behaviours Questionnaire (SBQ) The SBQ is an adaptation of the Sleep Behaviour Self-Rating Scale (Kazarian, Howe, & Csapo, 1979). It assesses the frequency of maladaptive sleep habits (e.g., “I spend a lot of time lying awake in bed

L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

at night”) during the previous two weeks using 14 questions on a scale ranging from ‘0’ (never) to ‘4’ (very often). Treatment Perception Questionnaire (TPQ) This 16-item questionnaire was developed by our team to assess participants' satisfaction with the content of the minimal treatment (9 items), the psychologist (4 items), and the treatment format (e.g., schedule and telephone consultations; 3 items). The TPQ was administered at post-treatment only. Demographic and medical data Demographic data included age, marital status, level of education, socioeconomic status, tobacco, alcohol and caffeine consumption, physical activity, time since cancer diagnosis, cancer type and treatments received, presence of comorbid psychological or medical conditions, menopausal status, and medication use. Statistical analyses Data were entered and verified independently by two research assistants. Examination of missing data, outliers and distributions

49

was performed using standard procedures (Tabachnick & Fidell, 2006). No missing data was imputed. Analyses for the main hypotheses were performed using an intent-to-treat approach, including data from all randomized patients who completed at least the baseline assessment. All analyses were conducted using the SAS 9.3 software (SAS Institute, Cary, NC, USA) and the alpha level was set at 5%, two-tailed. Based on the suggestions of Frigon and Laurencelle (1993), only variables showing a moderate association (Pearson r  .30; Cohen, 1988) with at least 50% of dependent variables were controlled for in the analysis. No variable met this criterion among the ones studied (age, gender, menopausal status, tobacco, alcohol and caffeine consumption, physical activity, comorbid medical or psychiatric illness [past or present], past sleep difficulties, stressful life events [assessed with the List of Threatening Experiences questionnaire (Brugha, Bebbington, Tennant, & Hurry, 1985)], time since cancer diagnosis, type of cancer and treatments received [past and ongoing]). In order to assess changes on study variables within and between conditions, 2 (Groups: mCBT-I vs. CTL) X 4 (Time: pre- and post-treatment, 3-month, and 6-month follow-up) split-plot linear

Table 1 Participants' characteristics at baseline (N ¼ 38). Variable Age e mean (SD) Gender e n (%) Women Men Marital Status e n (%) Married/Cohabiting Single Separated/divorced Widowed Education e n (%) High-school or lower College or university Current occupation e n (%) Work (full or part-time) Retired Other Time since cancer diagnosis (month) e mean (SD) Cancer type e n (%) Breast Colorectal Other (lung, prostate, bowel, tongue, vulva) Currently receiving cancer treatment e n (%) Adjuvant treatments receiveda e n (%) Radiation therapy Chemotherapy Hormone therapy Medical comorbidity e n (%) Psychological comorbidity e n (%) Mood disorder Anxiety disorder Adjustment disorder Past psychiatric disorder e n (%) Insomnia duration (month) e mean (SD) Past insomnia syndrome e n (%) Current hypnotic medication useb e n (%) Medication dose mg/day (lorazepam equivalent)c e mean (SD) Sleep variablesb e mean (SD) ISI score Sleep latency (min) Total wake time (min) Total sleep time (min) Sleep efficiency (%)

mCBT-I (n ¼ 20) 56.9 (10.8)

Statistic t or c2

p

56.9 (10.0)

0.01

.99

CTL (n ¼ 18)

Total (N ¼ 38)

57.0 (9.4)

19 (95.0) 1 (5.0)

16 (88.9) 2 (11.1)

35 (92.1) 3 (7.9)

0.49

.49

13 2 3 2

10 3 4 1

23 5 7 3

(60.5) (13.2) (18.4) (7.9)

0.96

.81

13 (34.2) 25 (65.8)

0.63

.43

(65.0) (10.0) (15.0) (10.0)

8 (40.0) 12 (60.0)

(55.6) (16.7) (22.2) (5.6)

5 (27.8) 13 (72.2)

4 9 7 23.5

(20.0) (45.0) (35.0) (28.9)

4 9 5 19.1

(22.2) (50.0) (27.8) (25.8)

8 18 12 21.4

(21.1) (47.3) (31.6) (27.2)

0.23

.89

0.50

.62

16 1 3 12

(80.0) (5.0) (15.0) (60.0)

14 2 2 13

(77.8) (11.1) (11.1) (72.2)

30 3 5 25

(78.9) (7.9) (13.2) (65.8)

0.56

.75

0.63

.43

14 11 9 12

(70.0) (55.0) (45.0) (60.0)

11 11 5 9

(61.1) (61.1) (27.8) (50.0)

25 22 14 21

(65.8) (57.9) (36.8) (55.3)

0.33 0.15 1.21 0.38

.56 .70 .27 .54

2 1 4 10 3.9 4 4 1.3

(10.0) (5.0) (20.0) (50.0) (1.4) (23.5) (23.5) (0.5)

1 2 4 11 4.0 7 8 1.2

(5.6) (11.1) (22.2) (61.1) (1.3) (38.9) (44.4) (0.6)

3 3 8 21 3.9 11 12 1.2

(7.9) (7.9) (21.1) (55.3) (1.3) (31.4) (34.3) (0.6)

0.26 0.49 0.03 0.47 0.03 0.96 1.70 0.08

.61 .49 .87 .49 .97 .33 .19 .94

12.1 27.4 115.5 413.4 78.5

(4.0) (20.7) (71.6) (73.6) (11.8)

12.1 32.5 111.5 418.9 78.9

(5.4) (30.6) (42.5) (62.0) (8.5)

12.1 30.0 113.5 416.2 78.7

(4.7) (26.0) (57.6) (66.9) (10.0)

0.03 0.57 0.21 0.24 0.10

.97 .57 .84 .81 .92

Note. mCBT-I ¼ minimal cognitive-behavioural therapy for insomnia. a Sum of percentages is greater than 100% because some patients have received more than one adjuvant treatment. b Only for participants with baseline data (N ¼ 35). c Only for medication users (n ¼ 12).

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L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

(for continuous outcomes: subjective sleep variables, frequency of hypnotic use and dosage, psychological distress, quality of life and beliefs about sleep) and generalized (for binary outcomes: hypnotic use [yes/no]) mixed model analyses were completed to test Group, Time, and Interaction effects (SAS Institute, 2006). Simple effects (Kirk, 1995) were conducted to test temporal changes between preand post-treatment, and between the post-treatment and followup (using the average of 3- and 6-month follow-ups measures). To control for alpha error inflation, only four comparisons were made and the corrected alpha level was set at .15/4 ¼ .038, according to the simultaneous test procedure (Kirk, 1995). Effect sizes (d) (Cohen, 1988) were calculated from simple effects for continuous outcomes using the root mean square error of the model as an estimate of error variance (Bird, 2002), while odds ratios were reported as estimates of effect sizes for binary outcomes. To assess whether participants who received mCBT-I showed greater rates of clinically significant sleep improvement than CTL, two indicators were compared between groups and time using generalized mixed models: (1) sleep efficiency  85%; and (2) ISI total score < 8. A sleep efficiency of 85% or greater is typically used to discriminate between insomniacs and good sleepers (Morin, 1993). An ISI <8 has been shown to be a reliable indicator of the absence of clinically significant insomnia symptoms among inres, & Morin, dividuals with and without cancer (Bastien, Vallie 2001; Savard, Savard, et al., 2005).

F(3,90) ¼ 1.97, p ¼ .12, SOL, F(3,90) ¼ 2.62, p ¼ .06, and WASO, F(3,90) ¼ 1.01, p ¼ .39. Simple effects revealed that mCBT-I was associated with significant sleep improvements from pre- to posttreatment on all sleep variables (ds ranging from 0.46 to 1.32), whereas no significant time effect was found among CTL (see Table 2). There were no significant changes from the posttreatment to the follow-up phase in both groups. However, effect sizes suggest a slight improvement among CTL on the ISI total score (d ¼ 0.31), TWT (d ¼ 0.29), and WASO (d ¼ 0.30).

Treatment effects on hypnotic consumption No significant Group  Time interactions were found on the frequency (nights per week) of hypnotic consumption, F(3,90) ¼ 1.18, p ¼ .32, average dosage (mg/day, in lorazepam equivalent (Bezchilibnyk-Butler & Jeffries, 2004)), F(3,90) ¼ 0.90, p ¼ .45, as well as the proportion of users, F(3,90) ¼ 1.12, p ¼ .35 (see Table 3). However, a priori comparisons revealed a significant reduction in hypnotic dosage between pre- and post-treatment among mCBT-I participants only (d ¼ 0.40). There were no significant changes between the post-treatment and the follow-up for all hypnotic-related variables in both groups.

Treatment effects on secondary outcomes Results Participants' characteristics Table 1 presents the main demographic and medical characteristics of the sample (N ¼ 38). All participants were FrenchCanadian and Caucasian. The mean age of the participants was 57 years (range ¼ 33e75 yrs), and they were for the most part women (92.1%), treated for breast cancer (78.9%). The average duration of sleep difficulties was 3.9 months (range ¼ 1e6 months). No statistical differences were found between the two groups on any demographic, medical, and sleep variables. An important betweengroup difference was nonetheless found on the frequency of hypnotic use (twice as many CTL participants used hypnotic medication [8 vs. 4]). Treatment effects on sleep measures Significant Group  Time interactions were obtained on the ISI total score, F(3,94) ¼ 6.39, p < .001 (Fig. 2), SE, F(3,90) ¼ 3.86, p ¼ .01, and TWT, F(3,90) ¼ 3.53, p ¼ .02, but not on TST,

Significant Group  Time interactions were obtained on the HADS subscales of anxiety, F(3,94) ¼ 3.71, p ¼ .01, and depression, F(3,94) ¼ 2.65, p ¼ .05, the cognitive subscale of the EORTC-QOL, F(3,94) ¼ 3.16, p ¼ .03, the SBQ, F(3,94) ¼ 4.99, p ¼ .003, and the DBAS, F(3,94) ¼ 6.02, p < .001 (see Table 4). No significant interactions were found for fatigue, F(3,94) ¼ 2.12, p ¼ .10, and global quality of life, F(3,94) ¼ 1.21, p ¼ .31. A priori comparisons revealed a significant improvement on all measures among mCBT-I participants from pre- to post-treatment (ds ranging from 0.56 to 1.12), as well as a significant improvement among CTL on HADS-D scores (d ¼ 0.49) and the MFI score (d ¼ 0.50). At follow-up, there was a significant time effect on the HADS-D subscale in the mCBT-I condition (d ¼ 0.34). Specifically, an increase was observed at the 3-month follow-up, followed by a decrease 3 months later. Also, a significant improvement on the cognitive subscale of the EORTC-QOL was found among CTL (d ¼ 0.61). A significant time effect was also found in the mCBT-I group between post-treatment and follow-up, suggesting a recrudescence in maladaptive sleep habits (3-month ¼ 1.21; 6-month ¼ 1.39, compared to 1.14 at post-treatment), t(94) ¼ 3.28, p ¼ .001, but without reaching the level observed at pre-treatment (1.51).

Clinical significance

Fig. 2. ISI total scores by group and time assessment.

Table 5 shows that, after controlling for baseline values, there were significantly more mCBT-I participants reaching a sleep efficiency level 85% at post-treatment as compared with CTL (94% vs. 53%), F(1,90) ¼ 6.27, p ¼ .01. Odds ratios to reach a sleep efficiency level 85% at post-treatment (compared to baseline) were 5.8 times larger in mCBT-I than CTL (OR ¼ 42.9 vs. 7.4). In addition, there were significantly more mCBT-I participants having an ISI score <8 at post-treatment as compared to CTL participants (83% vs. 23%), F(1,94) ¼ 8.93, p ¼ .004. Odds ratios to report an ISI score <8 at post-treatment (compared to baseline) were 34 times larger in mCBT-I than CTL (OR ¼ 39.2 vs. 1.1). No significant time effects were found between the post-treatment and follow-up on any criterion in both conditions.

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Table 2 Mean scores (standard error) obtained on sleep variables by each group at each time assessment, and time effects obtained. Variable

ISI total score mCBT-I CTL SOL (min) mCBT-I CTL WASO (min) mCBT-I CTL TWT (min) mCBT-I CTL TST (min) mCBT-I CTL SE (%) mCBT-I CTL

Pre-treatment

Post-treatment

Pre to post

Mean (SE)

Mean (SE)

t (df ¼ 94)

d (95% CI)

12.06 (0.95) 12.11 (1.24)

5.32 (0.71) 11.31 (1.30)

6.84*** 0.66 NS

1.26 (1.62, 0.89) 0.15 (0.60, 0.30)

27.45 (4.87) 32.50 (7.00)

17.24 (3.08) 31.19 (4.85)

2.77** 0.33 NS

41.64 (10.87) 45.17 (6.21)

18.01 (2.84) 39.36 (8.96)

115.54 (16.85) 111.48 (9.74)

3-month FU

6-month FU

Post to FUa

Mean (SE)

Mean (SE)

t (df ¼ 94)

d (95% CI)

7.06 (1.46) 9.67 (1.46)

5.43 (0.96) 9.67 (1.55)

1.01 NS 1.33 NS

0.17 (0.17, 0.51) 0.31 (0.76, 0.15)

0.46 (0.78,-0.13) 0.06 (0.41, 0.30)

14.84 (2.29) 32.61 (7.35)

17.50 (3.16) 24.41 (5.67)

0.66 NS 0.63 NS

0.05 (0.19, 0.10) 0.12 (0.50, 0.26)

2.21* 0.68 NS

0.86 (1.63, 0.09) 0.21 (0.83, 0.40)

18.62 (2.90) 34.05 (6.57)

17.08 (2.66) 28.12 (4.78)

0.05 NS 1.28 NS

0.01 (0.22, 0.21) 0.30 (0.77, 0.17)

52.85 (5.85) 100.39 (13.40)

4.40*** 0.96 NS

1.32 (1.92, 0.73) 0.23 (0.72, 0.25)

53.29 (5.85) 93.27 (13.43)

52.22 (6.59) 80.14 (10.84)

0.02 NS 1.61 NS

0.00 (0.24, 0.24) 0.29 (0.64, 0.07)

413.44 (17.31) 418.87 (14.20)

461.78 (10.05) 438.87 (15.45)

3.45*** 1.34 NS

0.77 (0.33, 1.22) 0.31 (0.15, 0.77)

456.47 (10.07) 412.31 (20.25)

465.27 (11.33) 451.47 (14.53)

0.13 NS 0.43 NS

0.01 (0.24, 0.21) 0.10 (0.58, 0.37)

78.53 (2.77) 78.86 (1.94)

89.72 (1.15) 81.49 (2.33)

5.15*** 1.24 NS

1.25 (0.76, 1.73) 0.29 (0.18, 0.76)

89.48 (1.20) 81.27 (2.95)

89.83 (1.25) 84.74 (2.14)

0.06 NS 0.89 NS

0.01 (0.25, 0.24) 0.17 (0.21, 0.55)

FU ¼ follow-up; NS ¼ not significant; ISI ¼ Insomnia Severity Index; mCBT-I ¼ minimal cognitive-behavioural therapy for insomnia; CTL ¼ control; SOL ¼ sleeponset latency; WASO ¼ wake after sleep onset; EMA ¼ early morning awakening; TWT ¼ total wake time; TST ¼ total sleep time; SE ¼ sleep efficiency. Effect size: d ¼ 0.20 ¼ small effect; d ¼ 0.50 ¼ moderate effect; d ¼ .80 ¼ large effect (Cohen, 1988). *p < .05, **p < .01, ***p < .001. a Post-treatment vs. 3- and 6-month follow-up (averaged).

Table 3 Average consumption (standard error) of self-reported hypnotic medication at each time assessment, and time effects obtained. Variable

3-month FU

6-month FU

Post to FUa

Mean (SE)

Mean (SE)

t (df ¼ 94)

d (95% CI)

1.68 (0.71) 1.50 (0.65)

1.14 NS 0.27 NS

0.16 (0.11, 0.42) 0.03 (0.25, 0.19)

0.22 (0.13) 0.30 (0.13)

0.18 (0.09) 0.14 (0.08)

1.54 NS 0.62 NS

22.11 (10.25) 29.93 (10.77)

29.69 (11.41) 27.78 (10.56)

1.50 NS 0.13 NS

0.22 0.13 OR 1.95 0.94

Pre-treatment

Post-treatment

Pre to post

Mean (SE)

Mean (SE)

t (df ¼ 94)

d (95% CI)

1.44 NS 0.96 NS

0.04 (0.09, 0.01) 0.15 (0.47, 0.16)

1.55 (0.69) 1.26 (0.60)

2.20* 1.70 NS

0.40 0.36 OR 0.58 0.54

Night per week mCBT-I 1.29 (0.64) 1.18 (0.63) CTL 1.89 (0.66) 1.46 (0.63) Dosage in lorazepam equivalent (mg/day)b mCBT-I 0.29 (0.14) 0.09 (0.06) CTL 0.47 (0.17) 0.29 (0.14) Proportion of users mCBT-I 23.53 (10.29) 15.05 (8.40) CTL 44.44 (11.71) 30.07 (11.13)

1.36 NS 1.19 NS

(0.76, 0.04) (0.78, 0.06) (95% CI) (0.26, 1.29) (0.19, 1.52)

(0.06, 0.50) (0.55, 0.29) (95% CI) (0.80, 4.76) (0.37, 2.39)

FU ¼ follow-up; OR ¼ odds ratio; NS ¼ not significant; mCBT-I ¼ minimal cognitive-behavioural therapy for insomnia; CTL ¼ control. Effect size: d ¼ .20 ¼ small effect; d ¼ .50 ¼ moderate effect; d ¼ .80 ¼ large effect (Cohen, 1988). *p < .05. a Post-treatment vs. 3- and 6-month follow-up (averaged). b Only molecules that can be converted into lorazepam equivalent were used.

Intervention findings Based on answers to the TPQ, mCBT-I participants read 97.5% of the booklets on average, and 91.2% of the participants completed the quiz at the end of each booklet. The percentage of correct answers among all respondents was 87.6%. The level of satisfaction was rated at 4.6 on average with regard to the content of the intervention (which corresponds to “a lot”), and 4.7 on average for the psychologist (which corresponds to “enormously”). Discussion This study aimed to assess the efficacy of a minimal CBT intervention to treat acute insomnia comorbid with cancer. As expected, the results showed significantly greater improvements for several subjective sleep parameters at post-treatment among individuals who received the intervention as compared to control participants. All pre- to post-treatment time effects were significant among participants who received mCBT-I, while none was significant among CTL. Also, a significantly larger proportion of mCBT-I participants than controls reached an ISI score <8 and a sleep efficiency 85%, which is indicative of clinically significant improvements. No

differences in sleep variables were observed between posttreatment and follow-up, suggesting that therapeutic gains were well sustained up to 6 months after the intervention. Also, although we found no significant effect of the intervention on the frequency of hypnotic consumption or proportion of users, a significant decrease in hypnotic dosage was observed between pre- and posttreatment among mCBT-I participants only. Finally, mCBT-I was associated with a greater decrease in anxiety and depressive symptoms, maladaptive sleep habits, and erroneous beliefs about sleep, as well as with a greater improvement in subjective cognitive functioning, as compared with untreated participants. Overall, these results indicate that a minimal form of CBT-I is efficacious to treat acute insomnia among cancer patients. These results are consistent with those of Jansson and Linton (2005), who also found an early CBT intervention to be efficacious for individuals with no cancer reporting insomnia for 3e12 months. Our results go a step further by showing that acute insomnia can be successfully treated using a minimal, self-administered intervention. Minimal treatments are appealing, given their potential for increased accessibility, their lower cost, and reduced burden for the patients.

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L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

Table 4 Mean scores (standard error) obtained on secondary variables by each group at each time assessment and time effects obtained. Variable

3-month FU

6-month FU

Post to FUa

Mean (SE)

Mean (SE)

t (df ¼ 94)

Pre-treatment

Post-treatment

Pre to post

Mean (SE)

Mean (SE)

t (df ¼ 94)

d (95% CI)

5.42 (0.80) 5.40 (0.92)

3.98*** 1.18 NS

0.60 (0.90,-0.30) 0.22 (0.59, 0.15)

6.76 (0.92) 5.56 (0.95)

5.12 (0.68) 5.56 (1.09)

1.08 NS 0.29 NS

2.01 (0.44) 4.48 (0.98)

3.43*** 3.34***

0.77 (1.22,-0.32) 0.49 (0.78,-0.20)

3.71 (0.83) 3.94 (0.93)

2.88 (0.62) 4.28 (0.98)

2.50* 0.67 NS

0.34 (0.07, 0.61) 0.10 (0.39, 0.19)

1.36 (0.14) 1.54 (0.15)

2.42* 2.18*

0.56 (1.02,-0.10) 0.50 (0.96,-0.05)

1.41 (0.15) 1.37 (0.13)

1.37 (0.12) 1.57 (0.16)

0.58 NS 0.63 NS

0.06 (0.13, 0.24) 0.11 (0.47, 0.25)

73.55 (3.79) 60.99 (6.47)

3.25*** 0.86 NS

0.67 (0.26, 1.08) 0.27 (0.36, 0.91)

70.59 (4.40) 70.06 (3.76)

70.61 (3.18) 62.04 (5.04)

1.33 NS 1.17 NS

0.14 (0.35, 0.07) 0.24 (0.17, 0.65)

86.57 (3.23) 72.18 (5.58)

2.65** 0.62 NS

0.57 (0.14, 1.00) 0.16 (0.68, 0.36)

82.35 (3.79) 83.33 (4.90)

83.82 (3.70) 82.41 (3.81)

1.16 NS 2.69**

0.20 (0.54, 0.14) 0.61 (0.16, 1.06)

2.68 (0.26) 4.45 (0.37)

5.39*** 1.24 NS

1.12 (1.53,-0.70) 0.18 (0.46, 0.11)

2.99 (0.39) 4.34 (0.37)

3.23 (0.46) 4.32 (0.32)

1.60 NS 0.86 NS

0.27 (0.07, 0.61) 0.08 (0.25, 0.10)

1.14 (0.09) 1.75 (0.08)

5.47*** 1.14 NS

0.89 (1.22,-0.57) 0.25 (0.70, 0.19)

1.21 (0.13) 1.63 (0.08)

1.39 (0.13) 1.65 (0.09)

3.28*** 1.84 NS

0.38 (0.15, 0.61) 0.26 (0.54, 0.02)

HADS-A mCBT-I 7.82 (0.78) CTL 6.28 (1.14) HADS-D mCBT-I 4.94 (0.94) CTL 6.33 (1.08) MFI mCBT-I 1.71 (0.14) CTL 1.86 (0.17) EORTC-QOL e global mCBT-I 59.48 (4.52) CTL 55.25 (6.64) EORTC-QOL e cognitive mCBT-I 76.47 (3.12) CTL 75.00 (4.19) DBAS mCBT-I 4.45 (0.32) CTL 4.74 (0.44) SBQ mCBT-I 1.51 (0.09) CTL 1.86 (0.08)

d (95% CI) 0.13 (0.11, 0.37) 0.04 (0.23, 0.31)

FU ¼ follow-up; NS ¼ not significant; mCBT-I ¼ minimal cognitive-behavioural therapy for insomnia; CTL ¼ control; HADS-A ¼ anxiety subscale of the Hospital Anxiety and Depression Scale; HADS-D ¼ depression subscale of the Hospital Anxiety and Depression Scale; MFI ¼ Multidimensional Fatigue Inventory; EORTC-QOL ¼ European Organisation for Research and Treatment of Cancer e Quality of Life; DBAS ¼ Dysfunctional Beliefs about Sleep scale; SBQ ¼ Sleep Behaviour Questionnaire. Effect size: d ¼ .20 ¼ small effect; d ¼ .50 ¼ moderate effect; d ¼ .80 ¼ large effect (Cohen, 1988). *p < .05, **p < .01, ***p < .001. a Post-treatment vs. 3- and 6-month follow-up (averaged).

Table 5 Percentage (standard error) of patients meeting remission criteria at each time assessment, and time effects obtained. Remission criterion

3-month FU

6-month FU

Post to FUa

OR (95% CI)

% (SE)

% (SE)

t (df ¼ 90)

OR (95% CI)

3.73*** 3.16**

42.89 (5.80, 317, 21) 7.36 (2.10, 25.78)

96.8 (5.5) 49.7 (12.4)

90.8 (13.2) 63.4 (13.0)

0.10 NS 0.38 NS

1.17 (0.05, 27.57) 1.17 (0.51, 2.70)

4.43*** 0.20 NS

39.21 (7.56, 203.23) 1.14 (0.31, 4.17)

73.2 (12.0) 38.6 (12.7)

75.2 (11.5) 44.8 (13.9)

0.66 NS 1.62 NS

0.58 (0.11, 3.01) 2.39 (0.82, 6.95)

Pre-treatment

Post-treatment

Pre to post

% (SE)

% (SE)

t (df ¼ 90)

93.7 (5.3) 52.8 (13.0) 83.2 (9.5) 23.0 (11.0)

Sleep efficiency  85% mCBT-I 25.8 (8.8) CTL 13.2 (5.7) ISI total score < 8 mCBT-I 11.2 (6.1)b CTL 20.8 (8.1)b

Note. All percentages are controlled for baseline values. FU ¼ follow-up; OR ¼ odds ratio; NS ¼ not significant; mCBT-I ¼ minimal cognitive-behavioural therapy for insomnia; CTL ¼ control; ISI ¼ Insomnia Severity Index. **p < .01, ***p < .001. a Post-treatment vs. 3- and 6-month follow-up (averaged). b Some participants showed spontaneous remission between recruitment and completion of pre-treatment measures.

The present results suggest that a CBT-I in a bibliotherapy format combined with brief phone consultations could be implemented in cancer clinics, and be proposed to the patient as soon as an insomnia complaint is reported. Following a stepped care approach, which has been proposed as an ideal delivery model for insomnia treatment (Espie, 2009), patients for whom a minimal treatment is insufficient to achieve a clinical remission could then receive a more intense form of treatment (i.e., professionallyadministered CBT-I). However, studies are needed to assess the feasibility and utility of such an approach. The intervention tested in this study included some therapeutic contact through brief phone consultations. Further studies are needed in order to assess whether the addition of this therapeutic ingredient is a critical aspect of the efficacy of this intervention among cancer patients with acute insomnia. Data from the general population suggest that it would indeed provide significant benefits for the treatment of chronic insomnia and other psychological disorders (Mimeault & Morin, 1999; Riedel et al., 1995; Vincent & Holmqvist, 2010).

Results on secondary outcomes were also very encouraging. Other positive outcomes associated with this treatment included a decrease in depressive and anxiety symptoms. Previous studies conducted among individuals with cancer obtained similar results (Espie et al., 2008; Quesnel et al., 2003; Savard et al., 2005). Interestingly, an improvement in subjective cognitive functioning from pre- to post-treatment was found, replicating Quesnel et al.'s results (Quesnel et al., 2003) and suggesting that CBT-I may help to reverse this deleterious effect of insomnia (Caplette-Gingras, Savard, Savard, & Ivers, 2013). A greater decrease in dysfunctional beliefs about sleep and of maladaptive sleep behaviours was also observed among CBT-I participants, similar to individuals treated for insomnia without a comorbid condition (Espie et al., 2000; Jansson & Linton, 2005; Morin et al., 2002) and among breast cancer patients (Tremblay, Savard, & Ivers, 2009). It is also noteworthy that sleep improvements were well sustained at follow-up despite a slight decrease in the level of compliance with behavioural strategies among CBT-I participants. Given that dysfunctional beliefs about sleep and poor sleep habits are believed to play an important role in the maintenance of insomnia over time (Morin,

L. Casault et al. / Behaviour Research and Therapy 67 (2015) 45e54

1993), an early effect on these factors may be instrumental in preventing insomnia from becoming chronic. Contrary to what was expected, the intervention had no significant effect on hypnotic usage, with the exception of a modest but significant decrease in dosage (from 0.29 to 0.09 in lorazepam equivalent). Yet, other studies on the efficacy of CBT-I for insomnia comorbid with cancer have reported significant reductions in the consumption of hypnotics, in spite of the fact that no specific recommendation was formulated in this regard (Quesnel et al., 2003; Savard, Simard, et al., 2005). Our non-significant results may be attributable in part to the fact that fewer participants in the mCBT-I group were taking medication at baseline (n ¼ 4) as compared to control participants (n ¼ 8). Besides, given that regular users (3 nights/week) were excluded, hypnotic consumption was fairly low at study entry, thus leaving smaller room for improvement. The lack of a significant treatment effect on fatigue may appear surprising but is consistent with other studies (Berger et al., 2009; Savard, Simard, et al., 2005). Whether this is due to the lack of sensitivity to change of some fatigue measures (MFI) or indicates that fatigue and insomnia occur independently remains to be clarified. Strengths of this study include the recruitment of patients presenting with various degrees of psychological symptoms and hypnotic consumption, which increases the generalization of the results. On the other hand, the sample was small and comprised a very large proportion of women (92%) with a breast cancer diagnosis (79%), hence the efficacy of this intervention among individuals with various types of cancer remains unknown. Also, the findings' generalization is limited by a relatively low proportion of patients eligible for the study in the first place. Indeed, a large number of patients had too low an ISI score (n ¼ 302) or had chronic insomnia (n ¼ 187) at screening. Nonetheless, the sample size, although modest, yielded enough power to detect between-group differences as several large effect sizes were obtained. Indeed, although the duration and severity of symptoms was lower among our participants as compared to what is usually observed in chronic insomnia studies, the magnitude of treatment effects was similar to other, more intensive treatment modalities (individual or group therapy). In sum, these results highlight the importance of early screening and treatment of insomnia symptoms during the cancer care trajectory in order to decrease the risk that sleep difficulties become chronic and the negative consequences associated with it. Further studies should assess the efficacy of minimal interventions among larger samples and their cost-effectiveness as compared with standard CBT-I. Acknowledgements This research was funded by salary support awards from the Canadian Institutes of Health Research, held by the first and second authors, and by a research scientist award from the Fonds de la
du Que
bec held by the second author. We recherche en sante sincerely thank the patients for their participation in this study and Fred Sengmueller for revising the manuscript. We would also like to acknowledge the contribution of Nathalie Gagnon, Catherine
verine Hervouet, Julie Maheux, Gonthier, Jean-Philippe Gouin, Se

bastien Simard, Elaine
riault, and Sylvie Perron, Julie Roy, Se The
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