Trial Outcomes & Findings for A Randomized Control Trial Treating Depression With Yoga and Coherent Breathing Versus Walking in Veterans (NCT NCT03489122)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Screening, week 4, week 8, week 12

Results posted on

2025-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Iyengar Yoga and Coherent Breathing 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. yoga: 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.	Walking 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. walking: 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.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Control Trial Treating Depression With Yoga and Coherent Breathing Versus Walking in Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39 years n=5 Participants	54 years n=7 Participants	46.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Hamilton Depression Rating Scales	26 units on a scale n=5 Participants	17 units on a scale n=7 Participants	21.5 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Screening, week 4, week 8, week 12

Population: subject was lost to follow up

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.

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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 Screening	27 units on a scale	17 units on a scale
Hamilton Depression Rating Scales Change Week 4	16 units on a scale	5 units on a scale
Hamilton Depression Rating Scales Change Week 8	13 units on a scale	—
Hamilton Depression Rating Scales Change Week 12	16 units on a scale	—

SECONDARY outcome

Timeframe: 12 weeks, up to 22 weeks

Population: Although a contract was in place, no scans were ever performed on the participants and therefore, data were never collected. Additional details regarding why, specifically, scans were ultimately not performed were not provided by the PI who has retired.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Before Scans 1-3, before and after the week 4, 8, and 12 evaluations

Population: this data was not collected

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening and week 12 evaluation

Population: this data was not collected

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, and pre and post the week 4, 8, and 12 evaluations

Population: subject was lost to follow up

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.

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.
State Trait Anxiety Inventory-State (STAI) Pre-Week 4	40 units on a scale	43 units on a scale
State Trait Anxiety Inventory-State (STAI) Screening	46 units on a scale	40 units on a scale
State Trait Anxiety Inventory-State (STAI) Post-Week 4	36 units on a scale	32 units on a scale
State Trait Anxiety Inventory-State (STAI) Pre-Week 8	44 units on a scale	—
State Trait Anxiety Inventory-State (STAI) Post-Week 8	41 units on a scale	—
State Trait Anxiety Inventory-State (STAI) Pre-Week 12	37 units on a scale	—
State Trait Anxiety Inventory-State (STAI) Post-Week 12	45 units on a scale	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, and pre and post the week 4, 8, and 12 evaluations

Population: subject was lost to follow up

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.

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.
Exercise Induced Feeling Inventory (EIFI) Screening	19 units on a scale	16 units on a scale
Exercise Induced Feeling Inventory (EIFI) Pre-Week 4	12 units on a scale	10 units on a scale
Exercise Induced Feeling Inventory (EIFI) Post-Week 4	13 units on a scale	13 units on a scale
Exercise Induced Feeling Inventory (EIFI) Pre-Week 8	22 units on a scale	—
Exercise Induced Feeling Inventory (EIFI) Post-Week 8	25 units on a scale	—
Exercise Induced Feeling Inventory (EIFI) Pre-Week 12	17 units on a scale	—
Exercise Induced Feeling Inventory (EIFI) Post-Week 12	19 units on a scale	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Obtained at screening, and weeks 4, 8, and 12 evaluations.

Population: subject was lost to follow up

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.

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.
Pittsburgh Sleep Quality Inventory Screening	14 units on a scale	14 units on a scale
Pittsburgh Sleep Quality Inventory Week 4	7 units on a scale	6 units on a scale
Pittsburgh Sleep Quality Inventory Week 8	8 units on a scale	—
Pittsburgh Sleep Quality Inventory Week 12	7 units on a scale	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, weeks 4, 8, 12 evaluations

Population: subject was lost to follow up

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

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.
Beck Depression Inventory II (BDI-II) Screening	31 units on a scale	25 units on a scale
Beck Depression Inventory II (BDI-II) Week 4	25 units on a scale	16 units on a scale
Beck Depression Inventory II (BDI-II) Week 8	35 units on a scale	—
Beck Depression Inventory II (BDI-II) Week 12	32 units on a scale	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, and weeks 4, 8, 12 evaluations

Population: subject was lost to follow up

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

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.
Post Traumatic Check List - Civilian (PCL) Screening	44 units on a scale	43 units on a scale
Post Traumatic Check List - Civilian (PCL) Week 4	41 units on a scale	36 units on a scale
Post Traumatic Check List - Civilian (PCL) Week 8	57 units on a scale	—
Post Traumatic Check List - Civilian (PCL) Week 12	55 units on a scale	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12 evaluations.

Population: subject was lost to follow up

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.

Outcome measures

Outcome measures
Measure	Iyengar Yoga and Coherent Breathing n=1 Participants 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. yoga: 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.	Walking n=1 Participants 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. walking: 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.
Brief Pain Inventory (BPI) Week 4	42 units on a scale	0 units on a scale
Brief Pain Inventory (BPI) Week 8	51 units on a scale	—
Brief Pain Inventory (BPI) Week 12	49 units on a scale	—

Adverse Events

Iyengar Yoga and Coherent Breathing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Walking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Administrative Officer/R&D

VA Bedford Healthcare System

Phone: 781-687-2903

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place