Effectiveness of a meditation-based stress management program as an adjunct to pharmacotherapy in patients with anxiety disorder

Journal of Psychosomatic Research 62 (2007) 189 – 195

Effectiveness of a meditation-based stress management program as an adjunct to pharmacotherapy in patients with anxiety disorder Sang Hyuk Leea, Seung Chan Ahnb, Yu Jin Leea, Tae Kyu Choia,4, Ki Hwan Yooka, Shin Young Suha a

Department of Psychiatry, Pochon CHA University College of Medicine, Seongnam, South Korea b Korea Institute of Brain Science, Seoul, South Korea Received 13 June 2006

Abstract Objective: The objective of this study was to examine the effectiveness of a meditation-based stress management program in patients with anxiety disorder. Methods: Patients with anxiety disorder were randomly assigned to an 8-week clinical trial of either a meditation-based stress management program or an anxiety disorder education program. The Hamilton Anxiety Rating Scale (HAM-A), the Hamilton Depression Rating Scale (HAM-D), the State–Trait Anxiety Inventory (STAI), the Beck Depression Inventory, and the Symptom Checklist-90—Revised (SCL-90-R) were used to measure outcome at 0, 2, 4, and 8 weeks of the program. Results: Compared to the education group, the meditation-based stress management group showed significant improvement in scores on all anxiety scales (HAM-A, P=.00; STAI state, P=.00; STAI trait, P=.00; anxiety subscale of SCL-90-R, P=.00)

and in the SCL-90-R hostility subscale ( P=.01). Findings on depression measures were inconsistent, with no significant improvement shown by subjects in the meditation-based stress management group compared to those in the education group. The meditation-based stress management group did not show significant improvement in somatization, obsessive–compulsive symptoms, and interpersonal sensitivity scores, or in the SCL-90-R phobic anxiety subscale compared to the education group. Conclusions: A meditation-based stress management program can be effective in relieving anxiety symptoms in patients with anxiety disorder. However, well-designed, randomized, and controlled trials are needed to scientifically prove the worth of this intervention prior to treatment. D 2007 Elsevier Inc. All rights reserved.

Keywords: Anxiety disorder; Stress management; Meditation

Introduction Meditation includes techniques such as listening to breathing, repeating a mantra, detaching from thought processes, focusing attention, and bringing about a state of self-awareness and inner calmness [1]. In Asia, many forms of meditation have been developed among Taoists, Buddhists, and traditional Chinese medicine practitioners

4 Corresponding author. Department of Psychiatry, Pochon CHA University College of Medicine, Bundang CHA Hospital, 351 Yatap-Dong, Bundang-Gu, Seongnam 463-712, South Korea. Tel.: +82 31 780 5864; fax: +82 31 780 5874. E-mail address: [email protected] (T.K. Choi). 0022-3999/07/$ – see front matter D 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.jpsychores.2006.09.009

throughout history [2]. Meditation has been recently classified as a technique that induces a set of integrated physiological changes, termed relaxation response [3], and is now an accepted and effective complementary treatment for many psychosomatic disorders, such as chronic pain, fibromyalgia, cancer, epilepsy, and psoriasis [4– 8]. Meditation affects the endocrine system by inducing a progressive decrease in serum thyroid-stimulating hormone, growth hormone, and prolactin levels [9], and also acts on the immune system to increase the number of CD3+ lymphocytes and the antibody response to influenza vaccine [10,11]. Group sessions of meditation-based stress management can be effective in teaching people how to take better care of

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S.H. Lee et al. / Journal of Psychosomatic Research 62 (2007) 189 – 195

themselves, live healthier lives, and adapt more effectively to stress. Of a variety of possible meditation programs, the mindfulness-based stress reduction (MBSR) program of Kabat-Zinn [12] is a well-defined, systematic, and patientcentered approach that uses relatively intensive training in mindfulness meditation as the core of the program. Anxiety disorders, such as panic disorder and generalized anxiety disorder, are chronic and recurrent [13]. Patients with anxiety disorder are usually prescribed anxiolytics, unless contraindicated. However, a combination of pharmacotherapy and other kinds of treatment, such as cognitive therapy and cognitive–behavioral therapy, should be considered for these patients to maximize their chance of adapting successfully to social and occupational environments. Miller et al. [14] and Angst and Vollrath [15] showed that the MBSR program could effectively reduce symptoms of anxiety and panic, and could help to maintain these reductions in patients with generalized anxiety disorder, panic disorder, or panic disorder with agoraphobia. MBSR may provide a good candidate program for patients with anxiety disorder who do not want pharmaceutical medication, are pregnant, or want additional treatment. However, this study was limited by the noninclusion of either a randomly selected comparison group to test for placebo effects or a control group to test for concomitant medication effects [14,15]. Therefore, a carefully controlled trial should be implemented before this kind of stress management program is applied to patients with anxiety disorder. We have previously assessed the effectiveness of a newly developed meditation-based stress management program, which uses meditation techniques that are widely practiced among Koreans to improve health, in a preliminary trial on a group of pregnant women [16]. The meditation in this program was not the same as that used in the MBSR regime, although the programs have mindfulness meditation in common. We therefore aimed here to scientifically demonstrate the effectiveness of our group meditation program for stress management in patients with anxiety disorder.

Methods Subjects The study involved 46 patients with anxiety disorder. Subjects were recruited, through advertisement, among patients who were on treatment on an inpatient or an outpatient basis at the Department of Psychiatry, Pochon CHA University College of Medicine from March 2003 to August 2003. Subjects were between 20 and 60 years of age and fulfilled the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for generalized anxiety disorder or panic disorder with or without agoraphobia, as diagnosed by two psychiatrists using the Structured Clinical Interview for DSM-IV Axis I disorders [17,18]. In all subjects, symptoms were not

relieved after more than 6 months of pharmacotherapy. Written informed consent was obtained after a full description of the study had been presented to the subjects. Prior to the study, the subjects were treated with the antidepressant paroxetine (20 mg/day), sertraline (50 –100 mg/day), or fluvoxamine (50–100 mg/day) and with the anxiolytic alprazolam (0.125–0.5 mg/day). Psychiatrists confirmed that acute symptoms in the patients had stabilized and had remained unchanged for the past 2 months. The medications and dosages were not altered during the study. Exclusion criteria included any history of substance abuse or dependency, other psychiatric comorbidities, significant medical problems (such as diabetes mellitus, hypertension, tuberculosis, hepatitis, or pregnancy), and involvement in litigation or compensation. Assessment Subjects were randomly assigned to either the meditation program or the education program. Subjects were contacted on the day before the program started to encourage participation. Three subjects in the meditation group and two subjects in the education group dropped out during the study; thus, data from 21 meditation group subjects and 20 education group subjects were used for the final analysis. Subjects in the meditation group underwent weekly sessions of meditation treatment for 8 weeks, while the education group subjects received weekly sessions of general information on anxiety disorder. Both groups were assessed at baseline (0 week) and at 2, 4, and 8 weeks by self-report measures such as the Beck Depression Inventory (BDI), the State–Trait Anxiety Inventory (STAI), and the Symptom Checklist-90—Revised (SCL-90-R), as well as by a subjectblinded psychiatrist using a clinician-rated scale such as the Hamilton Depression Rating Scale (HAM-D) or the Hamilton Anxiety Rating Scale (HAM-A). Meditation program A psychiatrist and two meditation specialists with 5 years of education and training experience conducted the program. The meditation program consisted of a training program that can be performed by anxious patients, together with the psychiatrist’s complementary instruction on stress management in anxiety disorder (see Appendix A). The training program comprised medication, exercise, stretching, muscle buildup and relaxation, and hypnotic suggestion, with the goal of including it in everyday life through steady practice. At the end of each session, homework and an audio CD were given to participants. Education program The education program consisted of a presentation from the psychiatrist and education about the biological aspects of anxiety disorders, lasting for 1 h, once a week. The education

S.H. Lee et al. / Journal of Psychosomatic Research 62 (2007) 189 – 195

curriculum was as follows: bWhat is anxiety disorder (panic or generalized anxiety disorder)?Q on Weeks 1 and 2; bsymptoms and respiratory physiology of anxiety disorderQ on Weeks 3 and 4, bbiology, anatomy, and pharmacotherapy of anxiety disorderQ on Weeks 5 –7; and bsharing and discussionQ on Week 8. Stress management techniques and behavior therapy for anxiety disorder were not included. Outcome measures HAM-A The HAM-A, which was developed by Hamilton [19], is a semistructured interview comprising 14 items that assess the severity of anxiety symptoms. The scale consists of two factors (general psychological anxiety symptoms and cognitive symptoms) and is rated on a 5-point scale, with 5 being the worst. STAI The STAI, developed by Speilberger et al. [20], assesses state–anxiety and trait–anxiety in a more simplified and objective self-rated scale. The STAI consists of state– anxiety (X1 type) and trait–anxiety (X2 type) questions (20 items each). In this study, we used the STAI as standardized by Kim and Shin [21]. HAM-D The HAM-D is a clinician-rated scale that was developed by Hamilton [22] in 1960 and is one of the most widely used scales for the assessment of depression. The scale assesses the psychopathology and the psychology associated with depressive symptoms and emphasizes somatic symptoms. Of 21 items, the first 17 items assess the severity of depression, and 4 additional items provide information on other symptoms that need special treatment. Higher scores indicate more severe depression. BDI The BDI is a self-rated scale that was developed by Beck et al. [23] to assess the severity of depression. Twenty-one items are rated on a 3-point scale, with the total score obtained from the sum of all items. Lee et al. [24] assessed the validity and the reliability of the version of the scale used here. SCL-90-R The standardized SCL-90-R was administered to assess the severity of psychopathology. The original scale, which was developed by Derogatis [25], was standardized to the version of Kim et al. [26] and could be conveniently rated on an outpatient basis. The scale assesses various symptoms, thereby facilitating the detection of psychopathology. Data analysis Group differences in religion and occupation were analyzed using chi-square test, and group differences in

191

age, duration of pregnancy, education level, income, and baseline variables were analyzed using independent t tests. After the 8-week programs, the blast observation carried forwardQ method was used for intent-to-treat analysis. The effects of both programs were analyzed using repeatedmeasures analysis of variance, whereby two factors were considered to contrast the performance of both groups. These factors were: Time main effect (which indicated whether changes on an outcome variable occurred as a function of time irrespective of the treatment received) and TimeTreatment interaction (which indicated whether subjects in one treatment group changed more than their counterparts in the other group over time). SPSS/PC Version 11.5 was used for statistical analysis.

Results Sociodemographic characteristics There were no significant differences between groups in sociodemographic characteristics such as age, gender, education level, marital status, occupation, religion, and income (Table 1). The baseline scores for each scale were also not significantly different between the two groups. Comparison of anxiety scale scores between the meditation group and the education group Table 2 summarizes the effects of the two 8-week programs on anxiety scores. Statistically significant decreases in anxiety scores over time were revealed for HAM-A ( F = 24, df =3,42, P =.00), STAI-1 ( F=9, df = 3,42, Table 1 Sociodemographic characteristics of patients with anxiety disorder: the meditation-based stress management group versus the education control group

Age (years) (meanFS.D.) Duration of illness (months) (meanFS.D.) Education (years) (meanFS.D.) Income ($10 per month) (meanFS.D.) Sex [n (%)] Male Female Religion declared [n (%)] Employed [n (%)] Married [n (%)]

Meditation group (n=24)

Education group (n=22)

38.6F7.4

v 2 or t

df

P

38.1F9.7

t=0.2

44

.83

12.7F8.0

9.4F4.4

t=-1.3

44

.19

13.0F2.3

13.5F2.4

t=-0.7

44

.50

277.0F59.8

270.4F84.7

t=0.3

44

.75

15 (63) 9 (37) 15 (63)

15 (68) 7 (32) 15 (68)

v 2=0.2

1

.68

v 2=1.2

1

.27

17 (70) 15 (63)

16 (72) 15 (68)

v 2=0.2 v 2=2.3

1 1

.48 .89

S.D.=standard deviation; t=Student’s t test; v 2=chi-square test.

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S.H. Lee et al. / Journal of Psychosomatic Research 62 (2007) 189 – 195

Table 2 Scores on anxiety scales over time of patients with anxiety disorder: the meditation-based stress management program group versus the education control group Baseline

2 weeks

HAM-Aa (meanFS.D.) Meditation group 16.6F1.3 12.2F1.3 Education group 15.9F5.6 16.0F5.2 STAI-1a (meanFS.D.) Meditation group 24.7F14.6 19.1F12.6 Education group 28.6F11.7 27.1F10.6 STAI-2a (meanFS.D.) Meditation group 32.8F10.8 26.2F11.0 Education group 40.3F11.5 37.3F11.1 SCL-90-R anxiety subscalea (meanFS.D.) Meditation group 13.7F8.1 8.1F5.8 Education group 16.3F8.8 16.2F8.4

4 weeks

8 weeks

10.1F1.1 14.6F5.7

8.5F0.9 14.9F5.0

17.8F10.6 27.0F10.7

17.1F1.4 26.7F10.4

24.9F10.6 37.0F11.1

24.1F8.8 36.7F10.9

7.9F5.3 14.7F8.4

7.7F5.7 14.4F8.1

a Significant difference in the rate or in the magnitude of changes between the meditation-based stress management group and the education control group.

Comparison of depression scale scores between the meditation group and the education group The results listed in Table 3 show that the 8-week programs both induced statistically significant decreases in the depression scale scores over time: HAM-D ( F =15, df = 3,42, P =.00), BDI ( F = 8, df = 3,42, P =.00), and SCL-90-R depression subscale ( F = 6, df =3,42, P =.00). Comparative changes in depression scores between the two groups showed different results for different scales. After the TimeTreatment interactions were considered, the meditation group showed a significant improvement in HAM-D scores ( F= 4, df = 3,42, P =.01), but there were no significant differences between groups in BDI ( F=2, df = 3,42, P N.05) or the SCL-90-R depression subscale ( F=2, df = 3,42, P N.05). Fig. 1 shows changes in HAM-D scores over time. Comparison of SCL-90-R subscale scores between the meditation group and the education group

P =.00), STAI-2 ( F =13, df = 3,42, P =.00), and the SCL-90-R anxiety subscale ( F = 7, df = 3,42, P =.00). Compared to subjects in the education group, those in the meditation group showed greater improvement in anxiety scores. Differences between the two groups remained significant even after the TimeTreatment interaction was considered. Fig. 1 shows changes in major anxiety scores over time.

Table 4 lists the effects of the 8-week programs on SCL-90-R subscale scores, excluding the anxiety and depression subscales. Both groups showed statistically significant decreases over time for the somatization subscale ( F = 5, df = 3,42, P =.00), obsessive–compulsive subscale ( F=8, df = 3,42, P =.00), interpersonal sensitivity subscale ( F=8, df = 3,42,

Fig. 1. Anxiety and depression scales showing significant differences in the rate or in the magnitude of changes between the meditation-based stress management group and the education control group.

S.H. Lee et al. / Journal of Psychosomatic Research 62 (2007) 189 – 195 Table 3 Scores on depression scales over time for patients with anxiety disorder: the meditation-based stress management program group versus the education control group Baseline

2 weeks

HAM-Aa (meanFS.D.) Meditation group 13.5F5.9 9.8F5.0 Education group 14.7F5.2 13.6F4.7 BDIb (meanFS.D.) Meditation group 14.2F10.6 8.2F7.2 Education group 16.2F9.7 13.7F5.5 SCL-90-R depression subscaleb (meanFS.D.) Meditation group 15.5F9.8 9.7F7.4 Education group 20.8F14.0 18.9F12.0

4 weeks

8 weeks

8.8F4.7 13.0F4.3

8.1F4.4 12.5F4.7

7.7F6.5 12.5F5.4

6.8F5.4 13.1F6.4

8.9F7.4 18.0F11.5

9.1F6.7 17.1F9.7

a

Significant difference in the rate or in the magnitude of changes between the meditation-based stress management group and the education control group. b No significant difference in the rate or in the magnitude of changes between the meditation-based stress management group and the education control group.

P =.00), phobic anxiety subscale ( F= 6, df = 3,42, P =.00), and hostility subscale ( F= 4, df =3,42, P =.01). According to these results, after consideration of the TimeTreatment interaction, subjects in the meditation group showed more improvement in hostility scores ( F =3, df = 3,42, P =.04), but there were no significant differences in other subscales such as the somatization, obsessive–compulsive, interpersonal sensitivity, and phobic anxiety subscales. Scores for paranoid ideation and psychoticism showed no significant change over time, and there were no significant differences between the two groups.

between the two groups. This suggested that subjectively judged depressive symptoms showed no improvement, while those judged objectively responded favorably. Patients might therefore still be suffering from subjective symptoms of depression, regardless of contradictory objective findings. This particular finding is inconsistent with a previous study that was performed without a control group [13], which argued that meditation significantly improved both HAM-D and BDI scores in patients with anxiety disorders. We can therefore infer the following in our findings. First, there is a possibility that depressive symptom scores do not reveal significant decreases when compared to a control group. Second, the meditation program of this study might differ significantly from that used by Kabat-Zinn et al. [13]. Third, because our program was conducted for only 8 weeks, the effects on depression may not have reached significance compared to the control group. Fourth, the number of study participants was fairly low, possibly resulting in contradictory results. However, considering that the MBSR program of Kabat-Zinn was quite similar to our program in that they both included exercises such as stretching, relaxation, and suggestion, and that both programs were run for 8 weeks, we conclude that the first assumption is the most likely. The meditation group in this study showed SCL-90-R hostility scores that were significantly lower than those of

Table 4 Scores on SCL-90-R subscales over time for patients with anxiety disorder: the meditation-based stress management program group versus the education control group SCL-90-R subscales

Discussion The purpose of this study was to determine whether a stress management program based on meditation — an Oriental mind–body intervention — is more beneficial than educational sessions for patients with anxiety disorders. The findings revealed significant decreases in anxiety scale scores for patients with anxiety disorders undergoing the meditation-based program compared to patients with anxiety disorders undergoing the education program. These results are consistent with previous studies suggesting that meditation can relieve anxiety in patients with anxiety disorders, and they raise the possibility that stress management programs based on meditation could be applied as an adjunct to pharmacotherapy. In this study, meditation, compared to education, appeared to induce significant improvements in anxiety scale and hostility subscale scores, although the other variables assessed did not show similar results. Depression scores showed different results with different scales. According to HAM-D, the meditation group showed significant improvement, but the BDI and SCL-90-R depression subscales showed no significant differences

193

Baseline

2 weeks

Somatizationa (meanFS.D.) Meditation group 12.8F6.6 8.3F5.9 Education group 13.3F6.7 12.5F5.2 Obsessive–compulsivea (meanFS.D.) Meditation group 11.1F6.5 7.8F4.9 Education group 16.4F7.1 14.6F6.8 Interpersonal sensitivitya (meanFS.D.) Meditation group 8.7F11.4 5.7F3.8 Education group 11.4F7.4 10.1F5.9 Hostilityb (meanFS.D.) Meditation group 4.8F3.2 3.2F3.1 Education group 6.5F4.6 5.7F3.8 Phobic anxietya (meanFS.D.) Meditation group 8.2F6.7 5.2F5.2 Education group 6.5F6.1 5.4F5.3 Paranoid ideationa (meanFS.D.) Meditation group 3.9F3.1 2.5F2.6 Education group 5.2F2.8 6.3F8.5 Psychoticisma (meanFS.D.) Meditation group 7.0F6.2 4.7F5.0 Education group 9.1F6.9 7.7F5.1 a

4 weeks

8 weeks

8.4F5.3 12.5F5.2

8.1F5.8 12.1F5.0

8.4F4.9 14.8F6.3

8.0F4.6 14.2F7.1

5.7F3.4 9.8F6.3

5.2F3.4 9.5F6.3

3.8F3.1 5.4F3.9

3.1F3.1 5.2F4.0

5.0F5.2 4.9F4.7

4.8F5.0 4.9F4.3

2.8F2.8 4.4F2.3

2.4F2.3 4.0F2.3

4.7F4.8 7.4F5.4

4.4F4.9 7.3F5.2

No significant difference in the rate or in the magnitude of changes between the meditation-based stress management group and the education control group. b Significant difference in the rate or in the magnitude of changes between the meditation-based stress management group and the education group.

194

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the education group. This result is consistent with the earlier findings of Muskatel et al. [27] in their study of hostility and meditation. Hostility is a characteristic of type A behavior and, considering the close association of this behavior with coronary artery disease [28], this finding should be of significant clinical importance in psychosomatic medicine. Even though the SCL-90-R subscale scores for the somatization, phobic anxiety, obsessive–compulsive, and interpersonal sensitivity subscales decreased significantly over time, the scores for the two groups were not significantly different. It should be noted that phobic anxiety is a particularly important aspect of anxiety disorders such as panic disorder. Meditation has both cognitive and cognitive–behavioral aspects, and many aspects of meditation mirror cognitive– behavioral therapy, including focusing on sensation and thoughts instead of focusing on catastrophic thinking, turning a stressful situation into motive to change behavior, and practicing homework. In this study, most of the patients with panic disorder also had agoraphobia, and since the meditation group showed no significant improvement in phobic symptoms compared to the control group, we can assume that the cognitive approach of the meditation program adopted here was not effective enough. From this finding, we can infer the following assumptions. First, unlike cognitive therapy that focuses on thoughts, particularly on distorted thinking, meditation teaches subjects to leave thoughts as they are, thus not reducing phobic symptoms. Second, the patients might not have experienced true serenity. Third, although the patients reported that they trained themselves as instructed, they might not have worked enough to integrate meditation into their daily lives, thus not having enough effect on phobias. Finally, the duration of the program (8 weeks) and the number of training sessions (60 min weekly) might have been insufficient to produce a beneficial effect on this aspect. The changes in SCL-90-R subscale (paranoid ideation and psychoticism) scores over time were not significant, and changes over time for scale scores were not significantly different between two groups. This suggested that the meditation program used would not be effective in anxiety disorders with paranoid or psychotic symptoms. There are reports of meditation actually causing psychotic symptoms, and meditation is not recommended in anxiety cases with psychotic symptoms [29]. This study had the following limitations. First, the administered medication might have affected the results. However, carrying out an experimental study with little verification, free of pharmacotherapy, would be subject to ethical controversy, and discontinuation of the medications of patients who are stabilized by such medications is problematic. For these reasons, subjects were limited to patients with stabilized symptoms. However, delayed effects of the medication cannot be ruled out. Second, the control group underwent an educational program. A true control

group for the meditation program, which would accurately control for placebo effects, would have been a mimic or a sham program. Finally, there was no follow-up study to assess the long-term effects of the interventions. We observed maintenance of effects in some of the subjects, but objective data collection was not possible.

Conclusions This study suggests that in regard to the reduction of anxiety symptoms and hostility in patients with anxiety disorders, meditation-based stress management programs produce results better than those of education-based stress management programs. However, our findings need to be confirmed in larger study groups and without some of the abovedescribed limitations for meditation to be applicable in the clinical management of these patients.

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Appendix A. Construction of the meditation program First session

Second session

Third session

Fourth session

Fifth session

Sixth session Seventh session

Eighth session

Orientation: introduction to the program Education: philosophy, beliefs, and importance of meditation Stimulation of lower abdomen (Danjeon area) Movement of lower abdomen Movement of upper extremities Repetitive stimulation of the head and upper extremities Stretching of the body Focusing on bodily sensations Relaxation techniques Education: cause and pathophysiology of anxiety disorders Deep meditation Imagination Expansion of consciousness Education: coping strategies in anxiety attack Review: Sessions 2, 3, and 4 Deep meditation and tranquility Education: importance of relaxation techniques and meditation Review: Sessions 2, 3, and 4 Deep meditation and tranquility Education: meditation as part of daily life Review: Sessions 2, 3, and 4 Deep meditation and tranquility Education: review of previous research into Korean meditation Deep meditation and tranquility Discussion and sharing of the program