Social cognitive theory driven yoga intervention as a complementary therapy for clinical depression Manoj Sharma, MBBS, Ph.D. & Ashutosh Atri, MD, MS Session 3075.0, Board 2, Monday, November 9, 2009 at 10:30 AM.

Specific aims To test an innovative social cognitive theory driven six-month yoga-based behavioral intervention as a complementary therapy for clinical depression. To compare the score on Beck Depression Inventory in the innovative yoga-based intervention group (experimental) with the usual and customary therapy group (control) from before the intervention to immediately after the intervention at six months. To compare scores on expectations for yoga, self-efficacy for yoga, self control for yoga in the innovative yoga-based intervention group (experimental) with the usual and customary therapy group (control) from before the intervention to immediately after the intervention at six months.

Depression Findings from the 2006 Behavioral Risk Factor Surveillance System reveal that overall prevalence of current depressive symptoms in general population was 8.7% and lifetime diagnosis of depression was 15.7% making it a very common illness. Women were more likely to be diagnosed with depression (20.2% vs. 8.2%) than were men. Source: Strine TW, Mokdad AH, Balluz LS, Gonzalez O, Crider R, Berry JT, Kroenke K. Depression and anxiety in the United States: findings from the 2006 Behavioral Risk Factor Surveillance System. Psychiatr Serv. 2008;59(12):1383- 90.

Treatment of Depression New and most popular types of antidepressant medications are called Selective Serotonin Reuptake Inhibitors (SSRIs) e.g. fluoxetine (Prozac), citalopram (Celexa), sertraline (Zoloft) Other antidepressants include Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), tricyclics, monoamine oxidase inhibitors (MAOIs) Psychotherapy is also helpful – Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) have been shown to be effective.

Yoga & Depression Yoga is a complementary self-management technique that has been found to be useful but needs further study What is yoga? Origin is Sanskrit word Yog meaning “union” Physiological paradigm: Union of organ systems in the body (homeostasis) Psychological paradigm : Union of consciousness in the mind (balance) Scientific paradigm: Union of body and mind (psychosomatic equilibrium) in the environment

How Yoga Helps in Depression? Stretching of the muscles and breathing exercises release neurotransmitters in the brain that may be beneficial (Physical) Yoga relieves stress (Mental) Improving perspective toward life (Spiritual)

Depression & Yoga: Present Evidence Effects of a yoga program in early breast cancer patients undergoing radiotherapy (Study from India): Significant decreases in anxiety (p < .001), depression (p = .002), perceived stress (p < .001), 6 a.m. salivary cortisol (p = .009), and pooled mean cortisol (p = .03) in the yoga group compared with controls Raghavendra RM, Vadiraja HS, Nagarathna R et al. Effects of a yoga program on cortisol rhythm and mood states in early breast cancer patients undergoing adjuvant radiotherapy: a randomized controlled trial. Integr Cancer Ther. 2009;8(1):37-46.

Depression & Yoga: Present Evidence … 2 Yoga for veterans with chronic low-back pain (Study from United States): Single group pre-test post-test design with 10 week follow-up Significant improvements were found for pain, depression, energy/fatigue, and the Short Form- 12 Mental Health Scale Groessl EJ, Weingart KR, Aschbacher K, Pada L, Baxi S. Yoga for veterans with chronic low-back pain. J Altern Complement Med. 2008;14(9):1123-9.

Depression & Yoga: Present Evidence … 3 Evaluation of yoga for depression and anxiety (Study from Brazil): Quasi experimental design with one month follow-up Significant reductions in scores for anxiety, depression, tension in yoga group, with an increase in well-being as compared to control group Kozasa EH, Santos RF, Rueda AD, et al. Evaluation of Siddha Samadhi Yoga for anxiety and depression symptoms: a preliminary study. Psychol Rep. 2008;103(1):271-4.

Depression & Yoga: Present Evidence … 4 Effects of yoga on depression in older adults (Study from Taiwan): Cluster randomized trial After 6 months of yoga, the sleep quality, depression, and health status of older adults were all improved as compared to control group Chen KM, Chen MH, Chao HC, Hung HM, Lin HS, Li CH. Sleep quality, depression state, and health status of older adults after silver yoga exercises: Cluster randomized trial. Int J Nurs Stud. 2008 Oct 21. PMID: 18947826

Depression & Yoga: Present Evidence … 5 Effects of meditation and yoga on depression (Study from United States): Randomized pilot study compared meditation with yoga (and psychoeducation) vs. group therapy with hypnosis (and psychoeducation) vs. psychoeducation alone At 9-month follow-up significantly more meditation with yoga group participants experienced a remission from depression than did controls Butler LD, Waelde LC, Hastings TA, et al. Meditation with yoga, group therapy with hypnosis, and psychoeducation for long-term depressed mood: a randomized pilot trial. J Clin Psychol. 2008 Jul;64(7):806-20.

Depression & Yoga: Present Evidence … 6 Effects of yoga on depression (Study from United States): Intervention consisted of 20 Iyengar yoga classes 17 participants completed the study and significant reductions were found for depression, anger, anxiety, neurotic symptoms and low frequency heart rate variability Shapiro D, Cook IA, Davydov DM, Ottaviani C, Leuchter AF, Abrams M. Yoga as a Complementary Treatment of Depression: Effects of Traits and Moods on Treatment Outcome. Evid Based Complement Alternat Med 2007;4(4):493-502.

Depression & Yoga: Present Evidence … 7 Effect of yoga on depression (Study from India): 8 week Sahaj yoga intervention in a randomized controlled trial Significantly greater improvement on Hamilton Rating Scale for Depression and Anxiety in yoga group as compared to conventional treatment group Sharma VK, Das S, Mondal S, Goswampi U, Gandhi A. Effect of Sahaj Yoga on depressive disorders. Indian J Physiol Pharmacol. 2005;49(4):462-8.

STAGES of ASTHANGAYOGA Yama: Techniques for successful living in society Niyama: Techniques for managing and purifying self Asaana: Postures Pranayama: Breathing techniques Pratihara: Techniques for developing dispassion toward senses Dharana: Concentration techniques Dhyana: Meditation techniques Samadhi: Ultimate advanced meditation techniques and psychic procedures attained after regular practice for universal consciousness

BASIC COURSE IN KUNDALINI ENERGY YOGA FOR DEPRESSION Duration: Six weeks of initial training followed by six months of regular practice (class meets once a week for about an hour but you must practice everyday with the help of the video) Week 1: Foundations of Yoga & Depression Expectations and expectancies about benefits of yoga Strain relieving asanas (postures) Stress relieving shava asana (corpse pose) Week 2: Continued practice from week 1 building self efficacy Pranayama (breathing) techniques Week 3: Continued practice from weeks 1 & 2 building self-efficacy Initiation in Kundalini dhyana (meditation on pituitary gland)

BASIC COURSE IN KUNDALINI ENERGY YOGA FOR DEPRESSION … 2 Week 4: Continued practice from weeks 1, 2, & 3 building self-efficacy Refined practice of techniques: asanas (postures) pranayama (breathing), and Kundalini dhyana (meditation) Week 5: Continued practice from weeks 1, 2, 3, & 4 building self-efficacy Second stage of Kundalini dhyana (meditation on base of spine) Week 6: Continued practice from weeks 1, 2, 3, 4, & 5 Third stage of Kundalini dhyana (meditation on hypothalamus) Directions for continued practice for at least six months. Class meets every week and practices the above techniques for about an hour.

Design Experimental design Primary independent variable: intervention Second independent variable: time (within-subjects effect) with two levels: (1) start of the intervention; (2) immediately after completion of the intervention at six months Dependent variables for comparisons between experimental and control groups are: (1) Score on Beck Depression Inventory (2) Score on expectations for yoga (3) Score on self-efficacy for yoga (4) Score of self control for yoga

Population and Sampling Included: (1) Adults over 21 years who are competent and give voluntary informed consent; (2) have been diagnosed with moderate or severe depression as evidenced by a score of >15 on Beck’s Depression Inventory; (3) have intent and willingness to completes self report questionnaires at the beginning of the study and at six months; (4) have intent and willingness to participate in weekly yoga sessions for six months to be offered on Friday evenings at University of Cincinnati and continue home-based practice of yoga-related practices, if assigned to the yoga group. Excluded: (1) any overt disorder that limits the participants ability to understand and give informed consent; (2) cases of mild depression as evidenced by a score <14 on Beck’s Depression Inventory (3) any history of myocardial infarction, stroke, or active cancer within the past six months; (4) pregnant women; (5) history of any major surgery or hospitalization within the past six months

Sample size Four levels (2 groups x 2 times) Significance criterion at alpha of 0.05 Desired power at 0.80 An anticipated medium effect size of 0.30, A sample size of 7 per group is estimated -- As such a total of 28 subjects with 14 in each group (experimental and control) would be sufficient for efficacy testing. Since the time interval is six months a possible attrition of about 10-15% in the sample can occur which can be added to the sample. As a result 32 subjects will be recruited with random assignment of 16 subjects each into the yoga-based experimental group and the control group.

Instruments Beck Depression Inventory Twenty-one questions survey completed by patient Answers scored on 0 to 3 scale Minimal: 0 Severe: 3 Scoring: Score <15: Mild Depression Score 15-30: Moderate Depression Score >30: Severe Depression

Instruments …2 Demographic data: Age Gender Education (high school, some college, completed college or professional degree) Race (White, African American, Hispanic American, Indian American, Asian American, and other) Length of depression (in months) Concurrent Medications [SSRI’s (with trade names), SNRI’s (with trade names), Tricyclics (with trade names), MAO inhibitors (with trade names), St. John’s Wort, Others] Concurrent Psychotherapy

Instruments …3 Scale measuring expectations, expectancies, self-efficacy, and self control to perform yoga-related behaviors and past week performance of yoga-related behaviors. The four behaviors are strain relieving low physical impact yogic postures (asana), stress relieving relaxation (shava asana), stress relieving yogic breathing (pranayama), and meditation (dhyana).

Data analysis All data will be analyzed using the Statistical Package for Social Sciences (SPSS), Version 16.0 at the University of Cincinnati. Each of the dependent variable will be tested using the one between-groups and one within-subjects statistical design