An interventional study of yoga and walking in Depressive Disorder, Major and Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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Among 25 studies in Depressive Disorder, Major by VA Office of Research and Development — 7 open to participants now, 7 under way, 1 of them phase 3. Depressive Disorder, Major · VA Office of Research and Development.
Among the 25 studies in Depressive Disorder, Major by VA Office of Research and Development, this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2022, is one of 17 with no phase, and was the 11th registered.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
Browse Depressive Disorder, Major studies →7 of the 25 studies in Depressive Disorder, Major by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 18+
VA Office of Research and Development · Sites in United States
Ages 18–75
VA Office of Research and Development · Sites in United States
Ages 18–60
VA Office of Research and Development · Sites in United States
Ages 18+
VA Office of Research and Development · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 412 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 293 (71%) stop at 75 or younger; 55 take children under 18; 98 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 2 · Phase 4 2
First in 2010; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 80 across 2,532 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 112 across the 24 interventional studies, 0 across the 1 observational. Of the 16 that completed or were terminated, 14 (88%) have results posted.
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VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
2 of the studies in Depressive Disorder, Major by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05553353VA Office of Research and DevelopmentDosing rTMS for Depression Post-SCI | 2027-04-15 |
| NCT05491538VA Office of Research and DevelopmentAcceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness | 2027-11-26 |
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Among the 25 studies in Depressive Disorder, Major by VA Office of Research and Development, from their registry updates:
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The proposed study addresses a gap regarding the need for effective Major Depressive Disorder (MDD) treatments and the 40% of individuals treated with antidepressant medications that do not achieve full remission. This study tests a novel approach for treating MDD in a Randomized Control Trial (RTC) using yoga versus walking interventions to correct an imbalance in the Autonomic Nervous System; an over active Sympathetic Nervous System (fight or flight) an underactive Parasympathetic Nervous System (PNS) (rest, renewal and social engagement) and associated under activity in the neurotransmitter, gamma aminobutyric acid (GABA). This novel approach is complimentary to the use of antidepressant medications that primarily target the monoamine systems. Low activity in the PNS and GABA systems are also found in MDD, PTSD, and Alcohol Use Disorder, disorders representing a high healthcare burden in the Veteran population. This intervention has potential to provide relief for MDD and other disorders relevant the Veteran population
Suspension of all non-essential research due to Corona Virus Disease (COVID)
Overview The study tests the hypothesis that an imbalance in the autonomic nervous system with to much sympathetic tone (Fight or Flight) and to little parasympathetic tone (rest, renewal and social engagement) and associated low activity in the neurotransmitter gamma aminobutyric acid (GABA) is associated with negative emotional states and may be a crucial underlying link between negative emotions and poor health such that the correction of these imbalances will be associated with decreased depressive symptoms in Veterans with Major Depressive Disorder (MDD). Study Design: This is a Phase 2, longitudinal, efficacy, randomized controlled trial. Veterans with MDD will be evaluated for eligibility and randomized to 12-week intervention providing two-sessions per week of either an intervention of yoga and coherent breathing at five breaths per minute or walking at 2.5 miles an hour, such that the groups are matched for metabolic demand, interaction with research staff and group effect. Depression scales will be collected at baseline and weeks 4, 8, and 12. Mood scales and RSA will be collected at baseline and pre and post interventions at weeks 4, 8, and 12. Magnetic resonance spectroscopy (MRS) data for thalamic GABA levels will be collected at baseline (Scan 1), after the 12-week intervention (Scan 2) which is immediately followed by the assigned intervention and Scan 3. The primary outcome measure is depression symptoms assessed using established rating scales. The secondary outcome measure is the thalamic GABA levels. The tertiary outcome measure is Respiratory Sinus Arrhythmia (RSA), a measure of high frequency Heart Rate Variability and a marker of parasympathetic tone. Evaluations are designed to address changes over the course of the study, and acute changes before and after interventions at week 4, 8, and 12 evaluations. Instruments: Depression scales include the Hamilton Rating Scale for Depression-17 (HDRS) and the Beck Depression Inventory II (BDI-II). Mood scales include the Spielberger State -Trait Anxiety Inventory (STAI) and the Exercise -Induced Feeling Inventory (EIFI). Post Traumatic Stress Disorder (PTSD) scales include the Clinician Administered Posttraumatic Stress Scale (CAPS) and the PTSD Check List - Civilian (PCL-C). Inclusion Criteria: The study will include 18 to 65 year old males and females Veterans with a current diagnosis of MDD who have a HDRS scores to 14 at screening. If subjects have been taking a stable dose of antidepressants that target a monoamine system for at least three months with no anticipated changes during the study, they will be allowed to continue their medication. Exclusion Criteria: The following are not allowed: history of psychosis or bipolar illness; history of suicidal ideation with intent in the last year; current mind-body practice (e.g., yoga, Tai Chi, Qigong, breathing practices, or meditation); more than three current criteria for Alcohol or Substance Use Disorder using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; a current Substance Use Disorder, a neurologic or medical condition that could compromise subject safety or the integrity of the study. Blinding: Individuals scoring the depression scales, or analyzing the MRS and RSA data will be blind to group assignment. Hypothesis: I.a: The yoga group but not the walking group will show decreased in depressive symptoms on the HDRS and BDI-II from screening to week 12. 1.b: Subjects who are still depressed at baseline despite treatment with a stable dose (> 3 months) of antidepressants treatment will show decreased depressive symptoms in the yoga but not the walking group. 1.c: If present at baseline, there will be a greater decrease in PTSD symptoms on the CAPS in the yoga compared to the walking group. 2: There will be an increase in GABA levels over the course of the three scans in the yoga but not the walking group. 3: Over the course of the intervention and from pre to post-intervention at weeks 4, 8, and 12 there will be an improvement in the mood scales (STAI and EIFI), and increase in RSA in the yoga but not the walking group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Current mind-body practice defined as more than 6 one-hour sessions in the last 6 months
Has been treated psychotropic medications such as mood stabilizers
Benzodiazepines or pain medication other than Non Steroidal Anti-Inflammatory Drugs (NSAIDS) in the last three months except for procedure related pain management
Anxiety disorders with current symptoms that would impair participation in the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The yoga intervention consists of Iyengar yoga method and coherent breathing sessions for 90 minutes twice a week or a maximum of 24 interventions over the 12 week intervention.
Behavioral: yoga
The walking intervention consists of walking sessions at 2.5 miles an hour on a flat surface for 60 minutes twice a week or a maximum of 24 interventions over the 12 week intervention.
Behavioral: walking
The yoga intervention consists of Iyengar yoga method and coherent breathing sessions for 90 minutes twice a week or a maximum of 24 interventions over the 12 week intervention.
The walking intervention consists of walking sessions at 2.5 miles an hour on a flat surface for 60 minutes twice a week or a maximum of 24 interventions over the 12 week intervention.
Hamilton Depression Rating Scales Change
The Hamilton Depression Rating Scale for Depression is a clinician administered scale used to assess depressive symptoms. A 17-item clinician administered scale. The maximum score being 52. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. A score of 0-7 is generally accepted to be within the normal), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Time frame: Screening, week 4, week 8, week 12
Gamma Amino Butyric Acid (GABA) Change
Magnetic Resonance Spectroscopy (MRS) will be used to measure GAB levels in the left thalamus Scan 1 prior to randomization, Scan 2 after the 12-week intervention, immediately after Scan 2 there will be a yoga or walking intervention determined by group assignment that will be immediately followed by Scan 3. Participation in the study maybe up to 22 weeks due to the need to scan females who are cycling in the first half of their menstrual cycle.
Time frame: 12 weeks, up to 22 weeks
Respiratory Sinus Arrhythmia (RSA)
Electrocardiogram data will be obtained at rest, during a 3 minute aerobic step test and during recovery for RSA analysis at the above times. RSA measures the vagal component of heart rate variability. It is a marker of parasympathetic activity.
Time frame: Before Scans 1-3, before and after the week 4, 8, and 12 evaluations
Clinician Administered Posttraumatic Stress Scale (CAPS)
This is an exploratory measure. Clinician Administered Posttraumatic Stress Scale (CAPS) is a clinician administered interview to diagnose the severity of Post Traumatic Stress Disorder (PTSD). Decreasing CAPS scores are a marker of decreasing PTSD symptoms. CAPS scores of greater than or equal to 20 indicate at least mild PTSD.
Time frame: Screening and week 12 evaluation
State Trait Anxiety Inventory-State (STAI)
The State-Trait Anxiety Inventory (STAI) is a self-administered instrument designed for serial assessment of state anxiety. It has 20 items and is rated on a 4-point scale. Responses for the scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. The range of scores is 20-80 with higher scores indicating higher anxiety.
Time frame: Screening, and pre and post the week 4, 8, and 12 evaluations
Exercise Induced Feeling Inventory (EIFI)
Exercise-Induced Feeling Inventory (EIFI) is a self-administered instrument designed to assess four distinct feeling states associated with bouts of physical activity. It consists of 12 items that capture 4 distinct feeling states: Revitalization, Tranquility, Positive Engagement, and Physical Exhaustion. Improvements are associated with increased scores on Revitalization, Tranquility, Positive Engagement, and decreased scores on Physical Exhaustion. All items are scored on a 5-point scale anchored from 0 (do not feel) to 4 (feel very strongly). The range of scores is 0-48 with higher scores on the EFI total and subscales indicate more positive mood states, except on the Physical Exhaustion subscale where high scores indicate greater physical exhaustion.
Time frame: Screening, and pre and post the week 4, 8, and 12 evaluations
Pittsburgh Sleep Quality Inventory
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI consists of 24 questions or items measuring seven dimensions from 0 (best) to 3 (worst): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep.
Time frame: Obtained at screening, and weeks 4, 8, and 12 evaluations.
Beck Depression Inventory II (BDI-II)
Beck Depression Inventory (BDI-II) is a 21-item self-administered instrument designed for the assessment of depressive symptoms, with higher scores reflecting greater severity. The items are scored on a 4-point scale where answers are assigned a point value from zero to three. Minimal Depression: Zero - 13; Mild Depression: 14 - 19; Moderate Depression: 20 - 28; Severe Depression: 29 - 63
Time frame: Screening, weeks 4, 8, 12 evaluations
Post Traumatic Check List - Civilian (PCL)
PTSD Check List - Civilian (PCL-5) is a 20-item self-administered scale and is rated on a 5-point scale (0="Not at all" to 4= "Extremely") corresponding to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for PTSD. Because not all Veterans have combat experience and not all trauma is from a military experience, the civilian version of the PCL will be used. A total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items
Time frame: Screening, and weeks 4, 8, 12 evaluations
Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI) consists of 9 items rated on an eleven point Likert Scale of pain intensity (0-10) will be used to assess pain over the last 24 hours. The range of scores is 0-90 with higher total scores indicate greater severity and impact of pain.
Time frame: Weeks 4, 8, 12 evaluations.
| Milestone | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
The Hamilton Depression Rating Scale for Depression is a clinician administered scale used to assess depressive symptoms. A 17-item clinician administered scale. The maximum score being 52. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. A score of 0-7 is generally accepted to be within the normal), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Screening | 27 | 17 |
| Week 4 | 16 | 5 |
| Week 8 | 13 | — |
| Week 12 | 16 | — |
Magnetic Resonance Spectroscopy (MRS) will be used to measure GAB levels in the left thalamus Scan 1 prior to randomization, Scan 2 after the 12-week intervention, immediately after Scan 2 there will be a yoga or walking intervention determined by group assignment that will be immediately followed by Scan 3. Participation in the study maybe up to 22 weeks due to the need to scan females who are cycling in the first half of their menstrual cycle.
No measurements were reported for this outcome.
Electrocardiogram data will be obtained at rest, during a 3 minute aerobic step test and during recovery for RSA analysis at the above times. RSA measures the vagal component of heart rate variability. It is a marker of parasympathetic activity.
No measurements were reported for this outcome.
This is an exploratory measure. Clinician Administered Posttraumatic Stress Scale (CAPS) is a clinician administered interview to diagnose the severity of Post Traumatic Stress Disorder (PTSD). Decreasing CAPS scores are a marker of decreasing PTSD symptoms. CAPS scores of greater than or equal to 20 indicate at least mild PTSD.
No measurements were reported for this outcome.
The State-Trait Anxiety Inventory (STAI) is a self-administered instrument designed for serial assessment of state anxiety. It has 20 items and is rated on a 4-point scale. Responses for the scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. The range of scores is 20-80 with higher scores indicating higher anxiety.
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Screening | 46 | 40 |
| Pre-Week 4 | 40 | 43 |
| Post-Week 4 | 36 | 32 |
| Pre-Week 8 | 44 | — |
| Post-Week 8 | 41 | — |
| Pre-Week 12 | 37 | — |
| Post-Week 12 | 45 | — |
Exercise-Induced Feeling Inventory (EIFI) is a self-administered instrument designed to assess four distinct feeling states associated with bouts of physical activity. It consists of 12 items that capture 4 distinct feeling states: Revitalization, Tranquility, Positive Engagement, and Physical Exhaustion. Improvements are associated with increased scores on Revitalization, Tranquility, Positive Engagement, and decreased scores on Physical Exhaustion. All items are scored on a 5-point scale anchored from 0 (do not feel) to 4 (feel very strongly). The range of scores is 0-48 with higher scores on the EFI total and subscales indicate more positive mood states, except on the Physical Exhaustion subscale where high scores indicate greater physical exhaustion.
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Screening | 19 | 16 |
| Pre-Week 4 | 12 | 10 |
| Post-Week 4 | 13 | 13 |
| Pre-Week 8 | 22 | — |
| Post-Week 8 | 25 | — |
| Pre-Week 12 | 17 | — |
| Post-Week 12 | 19 | — |
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI consists of 24 questions or items measuring seven dimensions from 0 (best) to 3 (worst): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep.
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Screening | 14 | 14 |
| Week 4 | 7 | 6 |
| Week 8 | 8 | — |
| Week 12 | 7 | — |
Beck Depression Inventory (BDI-II) is a 21-item self-administered instrument designed for the assessment of depressive symptoms, with higher scores reflecting greater severity. The items are scored on a 4-point scale where answers are assigned a point value from zero to three. Minimal Depression: Zero - 13; Mild Depression: 14 - 19; Moderate Depression: 20 - 28; Severe Depression: 29 - 63
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Screening | 31 | 25 |
| Week 4 | 25 | 16 |
| Week 8 | 35 | — |
| Week 12 | 32 | — |
PTSD Check List - Civilian (PCL-5) is a 20-item self-administered scale and is rated on a 5-point scale (0="Not at all" to 4= "Extremely") corresponding to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for PTSD. Because not all Veterans have combat experience and not all trauma is from a military experience, the civilian version of the PCL will be used. A total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Screening | 44 | 43 |
| Week 4 | 41 | 36 |
| Week 8 | 57 | — |
| Week 12 | 55 | — |
Brief Pain Inventory (BPI) consists of 9 items rated on an eleven point Likert Scale of pain intensity (0-10) will be used to assess pain over the last 24 hours. The range of scores is 0-90 with higher total scores indicate greater severity and impact of pain.
| units on a scale | Iyengar Yoga and Coherent Breathing | Walking |
|---|---|---|
| Week 4 | 42 | 0 |
| Week 8 | 51 | — |
| Week 12 | 49 | — |
Collected over While participants were to be screened weekly for Adverse Events (to include the 12-week intervention and follow-up calls at 2 and 6 months post-intervention) they were actually monitored/assessed for a shorter duration of time. The participant in the yoga arm was followed weekly throughout the 12-week intervention, and the participant in the walking arm was followed weekly for 7 weeks until lost to follow-up due to their personal scheduling constraints.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iyengar Yoga and Coherent Breathing | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Walking | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
study was terminated due to extremely low enrollment
| Age, Categorical(Participants) | Iyengar Yoga and Coherent Breathing | Walking | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Iyengar Yoga and Coherent Breathing | Walking | Total |
|---|---|---|---|
| Mean | 39 (39 to 39) | 54 (54 to 54) | 46.5 (39 to 54) |
| Sex: Female, Male(Participants) | Iyengar Yoga and Coherent Breathing | Walking | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Iyengar Yoga and Coherent Breathing | Walking | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Iyengar Yoga and Coherent Breathing | Walking | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
| Hamilton Depression Rating Scales(units on a scale) | Iyengar Yoga and Coherent Breathing | Walking | Total |
|---|---|---|---|
| Mean | 26 (26 to 26) | 17 (17 to 17) | 21.5 (17 to 26) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Mechanisms for public access to final data sets underlying publications from this research: A limited Dataset (LDS) will be created and shard pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient form identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the data set.
Time frame: Final data sets will be available electronically after publication of the hypotheses or 5 years after protocol completion.
Access criteria: Data will be provided to qualified researchers after the written request of their data use plan is approved in writing by the Bedford VA research office. Original research team members are allowed to review potential publications to assure final data set use is consistent with collection circumstances. Member that review potential publications will be included as authors.
Ran from Jan 2022 to primary completion in Jun 2022, 5 months.
Results were first posted in May 2025, 2 years 10 months after primary completion.
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