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

NCT03489122 | Terminated Results

• 1 other identifier: MHBB-001-17S
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Disorder, Major; Post Traumatic Stress Disorder

Keywords

Depressive Disorder, Major; yoga; breathing exercise; parasympathetic; anxiety; Post Traumatic Stress Disorder; polyvagal

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening, week 4, week 8, week 12

Secondary Outcomes (1)

• Gamma Amino Butyric Acid (GABA) Change

  12 weeks, up to 22 weeks

Other Outcomes (8)

• Respiratory Sinus Arrhythmia (RSA)

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

• Clinician Administered Posttraumatic Stress Scale (CAPS)

  Screening and week 12 evaluation

• State Trait Anxiety Inventory-State (STAI)

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

Study Arms (2)

Iyengar yoga and coherent breathing

EXPERIMENTAL

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

Walking

ACTIVE COMPARATOR

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

Interventions

yoga BEHAVIORAL

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.

Iyengar yoga and coherent breathing

walking BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English
• Understands the risks and benefits of the study as listed in the Post Consent Quiz
• Females must agree to use an acceptable form of birth control \[Human Subjects\]
• Females are not pregnant and do not intend to become pregnant during the study
• Meets criteria for MDD on the Mini-International Neuropsychiatric Interview (MINI)
• Hamilton Rating Scale for Depression (HDRS) scores to 14 at screening
• If subjects have been taking antidepressants that target a monoamine system, the dose has been stable for at least three months with no anticipated changes during the study
• If subjects have been in a stable form of psychotherapy for three months, with no anticipated changes in their psychotherapy during the study (this would exclude time-limited manual-driven therapies such Cognitive Behavioral Therapy)
• Reliable contact information provided
• Has completed all required screening instruments and evaluations

You may not qualify if:

• History of psychosis
• History of bipolar illness
• History of suicidal ideation with intent and or a suicide attempt in the last year
• Desire to be treated for MDD with a new treatment during the study such as pharmacotherapy, somatic therapy or psychotherapy
• Current mind-body practice defined as more than 6 one-hour sessions in the last 6 months
• yoga
• Tai Chi
• Qigong
• breathing practices, or meditation
• Participates in physical exercise \> 5 hours/week that is equivalent to or greater than 6 metabolic equivalents (METs) in intensity
• Has been treated psychotropic medications such as mood stabilizers
• Valproic Acid
• Carbamazepine
• Lithium
• Benzodiazepines or pain medication other than Non Steroidal Anti-Inflammatory Drugs (NSAIDS) in the last three months except for procedure related pain management

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Anxiety Disorders

Interventions

Yoga; Walking

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Limitations and Caveats

COVID forced the study to have virtual interventions which affected enrollment. Early termination leading to only one participant per study arm prevented analysis.

Results Point of Contact

• Title: Administrative Officer/R&D
• Organization: VA Bedford Healthcare System

karen.smith9@va.gov

781-687-2903

Study Officials

• Chris C Streeter, MD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a behavioral intervention such that participants cannot be blinded. Participant questionnaires are fill out by participants without staff involvement. Outcome assessors: Clinicians completing the depression scales will be blinded to group assignment. Individuals analyzing magnetic resonance spectroscopy (MRS) and electrocardiogram (ECG) data will receive blinded data for analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to a Iyengar yoga and coherent breathing or walking intervention. Two interventions a week for 12 weeks are prescribed

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: January 11, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)