Treating major depression with yoga: A prospective, randomized, controlled pilot trial

Sudha Prathikanti1*, Renee Rivera2, Ashly Cochran3, Jose Gabriel Tungol4,

Nima Fayazmanesh5, Eva Weinmann6

1 Department of Psychiatry, School of Medicine, University of California San Francisco, San Francisco,California, United States of America, 2 Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, California, United States of America, 3 Department of Psychiatry, Weill Cornell Medicine, Cornell University, New York, New York, United States of America, 4 Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America, 5 Department of Psychiatry, Veterans Affairs Long Beach Healthcare System, Long Beach, California, United States of America, 6 Fuss Ueber Kopf Yoga Studio, Svastha Yoga Therapy Program, Stuttgart, Germany

Introduction

6) disturbance of appetite,

7) disturbance of sleep,

8) disturbance of energy,

9) impaired concentration

Major depression Symptoms

1)depressed mood,

2)loss of interest in previously

pleasurable activities,

3)feelings of inappropriate guilt or

worthlessness,

4)recurrent thoughts of death or

suicide,

5)Psychomotor slowing or agitation,

Conventional care for Depression

• Only 28% to 46% remission-one course of therapy

• 3 to 4 successive therapeutic trials- two third achieve full remission

• Treatment cost, stigma, intolerance of medications-persisting issues

• Need for novel, efficacious, safe, well accepted, easily accessible and tolerable interventions

Yoga for Depression

• Depression-most commonly self treated with Yoga

• 24 RCTs of Yoga for depression in 2015 against 5 in 2005

• 3 RCTs have used Yoga as mono therapy-all in India

• Reasonable evidence –Yoga as add-on to conventional intervention or mono therapy

• Many RCTs have methodological problems

Aim & Hypothesis

• To investigate potential mood benefits of hatha yoga as mono-therapy for mild-to-moderate major depression in a non-hospitalized, metropolitan U.S. population sample

• 8 week hatha yoga program would reduce depression severity and increase self efficacy & self esteem relative to attention control intervention in mild to moderate major depression

Methods

Inclusion criteria

• 18 years of age or older

• all genders & all ethnicities

• Mild/moderate Major depression ( BDI 14-19 or 20-28)

Exclusion criteria

• Other treatments

• Severe Depression (BDI >28)

• Suicidal attempts/ideation, psychosis, seizure disorder

• Pregnancy

• Other medical or psychiatric symptoms which might interfere & MMSE <24

Study Design- RCT

Recruitment process

• Ads posted throughout San Francisco, including libraries, community centers, shopping areas, online classifieds, and UCSF outpatient clinics and clinical trials websites

• PI screened participants

• Study coordinator not involved in assessment/delivery of intervention managed treatment allocation

• Statistician handled randomization & intervention assignment

• Block randomization with varying block size

• Stratified by Depression severity

Intervention

• Interviewed Yoga practitioners(n=15) & finalize yoga sequence

• PI pilot tested a yoga sequence in an open label trial

• Experimental intervention-90 minutes hatha yoga sequence with asana, pranayama & deep relaxation

• Control intervention- 90 min education module on Yoga theme

• Both intervention at Osher centre for integrative medicine twice weekly for 8 weeks

Assessments

S.no Tool baseline 2weeks 4weeks 6weeks 8weeks

1 Socio demography

+ - - - -

2 MINI + - - - -

3 MMSE + - - - -

4 BDI + + + + +

5 GSES + + + + +

6 RSES + + + + +

Results

BDI scores-across time and group

BDI, GSES & RSES Scores-GLS regression

Effect Size-Primary & Secondary outcome measures

• 9 of 15 completers in the yoga group achieved remission (60% remission) • 1 of 10 completers in the control group achieved remission (10% remission) • The difference in these remission rates was statistically significant

(Fisher’s Exact Test p-value = 0.018)

Analysis of remission

Discussion

• Robust study design & analysis

• Yoga as monotherapy in major depression

• First trial outside India with Yoga as monotherapy in major depression

• Generic yoga module

• Small sample size

• Self reported outcome measure

• Optimal yoga dose for mood effect?

• Durability of the yoga intervention effect?

Logic of using Regression for testing difference in means

Refer the example data analyzed by t test and correlation with same result-next two slides

Thank You