DepressionNCT02907476
The Treatment of Depression With Yoga and Walking
A study testing Iyengar Yoga and Walking in people with Depression and Major Depressive Disorder, run by Boston University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Major Depressive Disorder, PTSD
- What is being tested?
- Iyengar Yoga and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2017to 2 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Solomon Carter Fuller Building
Boston, Massachusetts, 02118
About this study
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.
Read the 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.
- Conditions
- Depression, Major Depressive Disorder, PTSD, Anxiety
- Being tested
- Iyengar Yoga, Walking
- Keywords
- Vagal-gamma amino-butyric acid (GABA), Yoga, Walking
- Medical subject headings
- Depression, Depressive Disorder, Major, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar YogaBehavioural
Also called Yoga
WalkingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Iyengar Yoga | Experimental | 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. Receives: Behavioral: Iyengar Yoga |
| Walking | Active comparator | 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. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (8)
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.
Measured: Week-12
Spielberger State-Trait Anxiety Inventory (STAI)
self-administered scale designed for serial assessment of state and trait anxiety.
Measured: Week-12
Exercise-Induced feeling Inventory (EIFI)
Self-administered instrument used to assess feelings states associated with physical activity.
Measured: Week-12
Pittsburgh Sleep Quality Index (PSQI)
Self-administered instrument used to assess sleep quality.
Measured: Week-12
Positivity Self Test (PST)
Self-administered instrument used to measure positive and negative feelings.
Measured: Week-12.
Columbia Suicide Safety Rating (C-SSR)
Clinician-administered instrument to assess suicide risk.
Measured: Week-12
PTSD Check List - Civilian (PCL-C)
Self-Administered measure of PTSD symptoms.
Measured: Week-12
Patient Health Questionnaire 9 (PHQ-9)
Self-Administered instrument used to measure depressive symptoms.
Measured: Week-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start4 Jan 2017
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Partners HealthCare, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Chris C Streeter, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907476
- Sponsor's protocol ID
- H-34681
- Other IDs
- 5R01AT007483-05
- Status last verified
- Oct 2019
- First submitted
- 2 Jun 2016
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is a Data Safety Monitoring Plan that includes Independent Monitors with expertise in the areas of Clinical Care, Imaging and Statistics.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Depression With Yoga and Walking
- ClinicalTrials.gov ID
- NCT02907476
- Acronym / sponsor ID
- H-34681
- Conditions
- Depression, Major Depressive Disorder, PTSD, Anxiety
- Keywords
- Vagal-gamma amino-butyric acid (GABA), Yoga, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Partners HealthCare, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iyengar Yoga | Experimental | Behavioral: Iyengar YogaTwelve-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. |
| Walking | Active comparator | Behavioral: WalkingTwelve-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar YogaAlso: Yoga | Behavioural | Iyengar Yoga |
| Walking | Behavioural | Walking |
Primary outcome
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.
8 secondary outcomes
Beck Depression Index Inventory (BDI-II)
Time frame: Week-12
Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Week-12
Exercise-Induced feeling Inventory (EIFI)
Time frame: Week-12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week-12
Positivity Self Test (PST)
Time frame: Week-12.
Columbia Suicide Safety Rating (C-SSR)
Time frame: Week-12
PTSD Check List - Civilian (PCL-C)
Time frame: Week-12
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Week-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Individual participant dataSharing planned: No. There is a Data Safety Monitoring Plan that includes Independent Monitors with expertise in the areas of Clinical Care, Imaging and Statistics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris C Streeter, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga and Walking in people with Depression and Major Depressive Disorder, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.