The Treatment of Depression With Yoga and Walking

NCT02907476 | Completed DMC

• 2 other identifiers: H-346815R01AT007483-05
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Major Depressive Disorder; PTSD; Anxiety

Keywords

Vagal-gamma amino-butyric acid (GABA); Yoga; Walking

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Week-12

• Spielberger State-Trait Anxiety Inventory (STAI)

  Week-12

• Exercise-Induced feeling Inventory (EIFI)

  Week-12

• Pittsburgh Sleep Quality Index (PSQI)

  Week-12

• Positivity Self Test (PST)

  Week-12.

Other Outcomes (1)

• 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).

  Week-12

Study Arms (2)

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.

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.

Behavioral: Walking

Interventions

Iyengar Yoga BEHAVIORAL

Also known as: Yoga

Iyengar Yoga

Walking BEHAVIORAL

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• Partners HealthCare: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Solomon Carter Fuller Building

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

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

Interventions

Yoga; Walking

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; 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

Study Officials

• Chris C Streeter, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: September 20, 2016
• Study Start: January 4, 2017
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)