search
Back to results

The Treatment of Depression With Yoga and Walking

Primary Purpose

Depression, Major Depressive Disorder, PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iyengar Yoga
Walking
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Vagal-gamma amino-butyric acid (GABA), Yoga, Walking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is fluent in English.
  • Subject understands the risks and benefits of the study as listed in the Post Consent Quiz.
  • Females agree to use an acceptable form of birth control.
  • Female had a negative pregnancy test or serum progesterone <= 0.30 ng/ml consistent with the non-luteal phase of the cycle prior to Scan 1.
  • Subject meets criteria for Diagnosis of Major Depressive Disorder on the SCID.
  • Subject had BDI-II score of at least 14 during screening.
  • Subjects who are prescribed a stable dose of antidepressants at least three months with no anticipated changes in their medications for the course of the study (i.e. 3 months after enrollment).
  • Subject who have been in a stable form of psychotherapy for three months with no anticipated changes in their psychotherapy for the course of the study (i.e. 3 months after enrollment).
  • Subject had given contact information.
  • Subject weighs up to 300 lbs at the discretion of the PI.
  • Subject has completed all required screening instruments and evaluations.

Exclusion Criteria:

  • Subject has a history of psychosis.
  • Subject has a history of bipolar illness.
  • Subject has a history of suicidal ideation with intent in the last year according to the Columbia Suicide Safety Rating (C-SSR) scale.
  • Subject has a history of suicide attempt with attempt to injure in the last year according to the C-SSR.
  • Subject who wishes to be treated for MDD with a new treatment during the study such as pharmacotherapy, or somatic therapy or psychotherapy.
  • Subject has a contraindication to magnetic resonance evaluation (e.g. pregnancy, a cardiac pacemaker, ferrous implant including shrapnel, or intrauterine devices (IUDs) with copper, claustrophobia that would prevent scanning, some tattoos with black ink on the head including permanent eyeliner).
  • Subject has a current mind-body practice (e.g., Tai Chi, Qigong, breathing practices, meditation) defined as more than 6 one-hour sessions in the last 6 months.
  • Subject has a current prayer practice > 2 hours a week (prayer group does not count, only prayer practice).
  • Subject participates in physical exercise >5 hours/week that is equivalent to or greater than 6 metabolic equivalents (METs) in intensity.
  • Subject has been treated with mood stabilizers in the last three months (e.g., Topiramate, Valproic Acid, or Lithium).
  • Subject has been treated with medications known to influence the GABA system in the last three months (e.g., anti-anxiety agents such as benzodiazepines, some sleeping aids such as Ambien, or sedative hypnotics).
  • Subject uses nicotine regularly in the last three months.
  • Subject has a neurologic condition that would in the opinion of the PI would affect the results of the magnetic resonance spectroscopy (MRS) scans.
  • Subject has a medical condition that could compromise subject safety or the integrity of the study.
  • Subject has a history of having more than 5 alcoholic drinks on 3 or more occasions in the prior three months.
  • Subject in the opinion of the PI would not be expected to complete the study including scheduling related issues, whose safety would be jeopardized by participation or who would jeopardize the study protocol.
  • Subject has an Axis-I diagnosis, other than depression that in the opinion of the PI would interfere with the subject's participation in this study.

Sites / Locations

  • Solomon Carter Fuller Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iyengar Yoga

Walking

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Brain gamma amino-butyric acid (GABA) levels (change will be measured)
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.

Secondary Outcome Measures

Beck Depression Index Inventory (BDI-II)
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)
self-administered scale designed for serial assessment of state and trait anxiety.
Exercise-Induced feeling Inventory (EIFI)
Self-administered instrument used to assess feelings states associated with physical activity.
Pittsburgh Sleep Quality Index (PSQI)
Self-administered instrument used to assess sleep quality.
Positivity Self Test (PST)
Self-administered instrument used to measure positive and negative feelings.
Columbia Suicide Safety Rating (C-SSR)
Clinician-administered instrument to assess suicide risk.
PTSD Check List - Civilian (PCL-C)
Self-Administered measure of PTSD symptoms.
Patient Health Questionnaire 9 (PHQ-9)
Self-Administered instrument used to measure depressive symptoms.

Full Information

First Posted
June 2, 2016
Last Updated
October 3, 2019
Sponsor
Boston University
Collaborators
Partners HealthCare, National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02907476
Brief Title
The Treatment of Depression With Yoga and Walking
Official Title
The Treatment of Depression With Yoga and Walking
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Partners HealthCare, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled trial is designed to test the Vagal-gamma amino-butyric acid (GABA) Hypothesis that one of the mechanisms by which yoga-based practices improve mood and decrease anxiety is by correcting an autonomic system (ANS) imbalance with too much activity in the sympathetic nervous system (SNS) and too little activity in the parasympathetic nervous system (PNS). This imbalance is associated with under activity in the GABA system. It is hypothesized that yoga-based practices increase activity in the PNS by increasing respiratory sinus arrhythmia (RSA), which is associated with increased activity in the GABA system and decreased depressive and anxiety symptoms.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder, PTSD, Anxiety
Keywords
Vagal-gamma amino-butyric acid (GABA), Yoga, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iyengar Yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
Walking
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Iyengar Yoga
Other Intervention Name(s)
Yoga
Intervention Type
Behavioral
Intervention Name(s)
Walking
Primary Outcome Measure Information:
Title
Brain gamma amino-butyric acid (GABA) levels (change will be measured)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Beck Depression Index Inventory (BDI-II)
Description
The BDI-II is the primary mood scale outcome measure. It is a self-administered scale used to assess symptoms of depression.
Time Frame
Week-12
Title
Spielberger State-Trait Anxiety Inventory (STAI)
Description
self-administered scale designed for serial assessment of state and trait anxiety.
Time Frame
Week-12
Title
Exercise-Induced feeling Inventory (EIFI)
Description
Self-administered instrument used to assess feelings states associated with physical activity.
Time Frame
Week-12
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self-administered instrument used to assess sleep quality.
Time Frame
Week-12
Title
Positivity Self Test (PST)
Description
Self-administered instrument used to measure positive and negative feelings.
Time Frame
Week-12.
Title
Columbia Suicide Safety Rating (C-SSR)
Description
Clinician-administered instrument to assess suicide risk.
Time Frame
Week-12
Title
PTSD Check List - Civilian (PCL-C)
Description
Self-Administered measure of PTSD symptoms.
Time Frame
Week-12
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
Self-Administered instrument used to measure depressive symptoms.
Time Frame
Week-12
Other Pre-specified Outcome Measures:
Title
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).
Description
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).
Time Frame
Week-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is fluent in English. Subject understands the risks and benefits of the study as listed in the Post Consent Quiz. Females agree to use an acceptable form of birth control. Female had a negative pregnancy test or serum progesterone <= 0.30 ng/ml consistent with the non-luteal phase of the cycle prior to Scan 1. Subject meets criteria for Diagnosis of Major Depressive Disorder on the SCID. Subject had BDI-II score of at least 14 during screening. Subjects who are prescribed a stable dose of antidepressants at least three months with no anticipated changes in their medications for the course of the study (i.e. 3 months after enrollment). Subject who have been in a stable form of psychotherapy for three months with no anticipated changes in their psychotherapy for the course of the study (i.e. 3 months after enrollment). Subject had given contact information. Subject weighs up to 300 lbs at the discretion of the PI. Subject has completed all required screening instruments and evaluations. Exclusion Criteria: Subject has a history of psychosis. Subject has a history of bipolar illness. Subject has a history of suicidal ideation with intent in the last year according to the Columbia Suicide Safety Rating (C-SSR) scale. Subject has a history of suicide attempt with attempt to injure in the last year according to the C-SSR. Subject who wishes to be treated for MDD with a new treatment during the study such as pharmacotherapy, or somatic therapy or psychotherapy. Subject has a contraindication to magnetic resonance evaluation (e.g. pregnancy, a cardiac pacemaker, ferrous implant including shrapnel, or intrauterine devices (IUDs) with copper, claustrophobia that would prevent scanning, some tattoos with black ink on the head including permanent eyeliner). Subject has a current mind-body practice (e.g., Tai Chi, Qigong, breathing practices, meditation) defined as more than 6 one-hour sessions in the last 6 months. Subject has a current prayer practice > 2 hours a week (prayer group does not count, only prayer practice). Subject participates in physical exercise >5 hours/week that is equivalent to or greater than 6 metabolic equivalents (METs) in intensity. Subject has been treated with mood stabilizers in the last three months (e.g., Topiramate, Valproic Acid, or Lithium). Subject has been treated with medications known to influence the GABA system in the last three months (e.g., anti-anxiety agents such as benzodiazepines, some sleeping aids such as Ambien, or sedative hypnotics). Subject uses nicotine regularly in the last three months. Subject has a neurologic condition that would in the opinion of the PI would affect the results of the magnetic resonance spectroscopy (MRS) scans. Subject has a medical condition that could compromise subject safety or the integrity of the study. Subject has a history of having more than 5 alcoholic drinks on 3 or more occasions in the prior three months. Subject in the opinion of the PI would not be expected to complete the study including scheduling related issues, whose safety would be jeopardized by participation or who would jeopardize the study protocol. Subject has an Axis-I diagnosis, other than depression that in the opinion of the PI would interfere with the subject's participation in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris C Streeter, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solomon Carter Fuller Building
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is a Data Safety Monitoring Plan that includes Independent Monitors with expertise in the areas of Clinical Care, Imaging and Statistics.

Learn more about this trial

The Treatment of Depression With Yoga and Walking

We'll reach out to this number within 24 hrs