The Treatment of Depression With Yoga and Walking
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|ClinicalTrials.gov Identifier: NCT02907476|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression Major Depressive Disorder PTSD Anxiety||Behavioral: Iyengar Yoga Behavioral: Walking||Not Applicable|
Subjects with Major Depressive Disorder (MDD) will be randomized into two treatment groups, a yoga group (YG) and a walking group (WG). After screening and Scan 1, each subject will be randomized to a 12-week yoga or walking intervention consisting of two group sessions and three homework sessions a week.The primary dependent variable will be brain gamma amino-butyric acid (GABA) levels measured using magnetic resonance spectroscopy (MRS) in two regions of interest (ROI)s: the thalamus and the anterior cingulate. GABA levels will be measured three times: Scan 1 prior to randomization, Scan 2 after the 12-week intervention, and immediately after Scan 2, subjects will participate in either the yoga intervention or walking intervention, followed immediately by Scan 3. The secondary dependent variable will be changes in depressive symptoms, mood and anxiety measured by valid and reliable psychological instruments obtained before each scan and at screening, week-4, week-8 and week-12. The third dependent variable will be respiratory sinus arrhythmia (RSA) a component of heart rate variability (HRV) that is an accurately index of vagal influences on the heart. RSA will be measured scan 1, pre and post an intervention session depending on group assignment at week 4, 8 and 12 evaluations, pre and post the yoga or walking intervention between Scan 2 and 3.
Aim 1: To complete 22 subjects in the yoga group and 22 subjects in the walking group for a total of 44 subjects with Major Depressive Disorder (MDD). Completion is defined at a baseline evaluation, a week-4 or week-8 evaluation and a week-12 evaluation with usable thalamic data for Scans 1, 2 and 3.
Aim 2. To measure changes in GABA levels over time using a mixed linear model analogue of repeated measures analysis-of-variance with independent groups in regional GABA levels in MDD subjects assigned to yoga and walking interventions.
Aim 3. To assess changes in psychological measurements and regional GABA levels over the course of the interventions using linear regression.
Aim 4. To assess changes in PNS using Respiratory Sinus Arrhythmia (RSA) over the course of the study using linear regression.
Aim 5. To assess changes in PNS, RSA and regional GABA levels over the course of the study using linear regression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Treatment of Depression With Yoga and Walking|
|Actual Study Start Date :||January 4, 2017|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Iyengar Yoga
Twelve-week Iyengar Yoga protocol with two 90-minute classes per week and three 30-minute homework assignments. Classes consist of approximately 60-minutes of yoga postures, 10-minutes of rest and transition, and 20-minutes of Coherent Breathing at 5 breaths per minute. Homework consist of 15-minutes of yoga postures and 15-minutes of Coherent Breathing. Coherent Breathing is CD guided. Yoga classes are taught by certified Iyengar Yoga instructors.
Behavioral: Iyengar Yoga
Other Name: Yoga
Active Comparator: Walking
Twelve-week walking intervention will consist of two 60-minute group-walking sessions per week and three 15-minute homework walking sessions at 2.5 miles per hour on flat surface. Walking classes are conducted by research staff.
- Brain gamma amino-butyric acid (GABA) levels (change will be measured) [ Time Frame: GABA will be measured three times: 1) during screening (scan 1), 2) within 5 weeks after the 12-week intervention (scan 2), 3) immediately following scan 2, but after a yoga or walking session (scan 3). ]Change in GABA levels will be measured using magnetic resonance spectroscopy (MRS) in two regions of interest (ROI)s: the thalamus and the anterior cingulate.
- Beck Depression Index Inventory (BDI-II) [ Time Frame: Week-12 ]The BDI-II is the primary mood scale outcome measure. It is a self-administered scale used to assess symptoms of depression.
- Spielberger State-Trait Anxiety Inventory (STAI) [ Time Frame: Week-12 ]self-administered scale designed for serial assessment of state and trait anxiety.
- Exercise-Induced feeling Inventory (EIFI) [ Time Frame: Week-12 ]Self-administered instrument used to assess feelings states associated with physical activity.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week-12 ]Self-administered instrument used to assess sleep quality.
- Positivity Self Test (PST) [ Time Frame: Week-12. ]Self-administered instrument used to measure positive and negative feelings.
- Columbia Suicide Safety Rating (C-SSR) [ Time Frame: Week-12 ]Clinician-administered instrument to assess suicide risk.
- PTSD Check List - Civilian (PCL-C) [ Time Frame: Week-12 ]Self-Administered measure of PTSD symptoms.
- Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Week-12 ]Self-Administered instrument used to measure depressive symptoms.
- Heart rate variability (HRV) will be measured by respiratory sinus arrhythmia (RSA), which is an index of vagal influences on the heart. ECG data will be collected to measure RSA using a GGP Biolog IBI monitor (UFI, Morro Bay, CA). [ Time Frame: Week-12 ]ECG data will be collected using three leads with 6 minutes at rest, three minutes of stepping, followed by six minutes of recovery. post a yoga or walking session, week 12 pre and post a yoga or walking session, and pre and post imaging session 2 (within 3 three weeks of week 12).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907476
|United States, Massachusetts|
|Solomon Carter Fuller Building|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Chris C Streeter, MD||Boston University|