Comparing Behavior Therapy and Yoga for Treating Depression Among Adults

NCT05546697 | Active Not Recruiting DMC

• 1 other identifier: 2022P001701
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

Brief Summary

This is a parallel group study design. The investigators propose to compare an online, synchronous group-based yoga intervention developed for individuals with depression to an online, synchronous individualized, evidence-based behavioral therapy for depression, or Brief Behavioral Activation Treatment for Depression (BA). This study is a multi-site randomized trial of adults with clinically significant depressive symptoms. Participants (N=518) will be randomized in an equal allocation ratio (i.e., 1:1) across two intervention groups: yoga and BA. Interventions will be provided over a 12-week period and assessments will occur at baseline (week 0), week 6, week 12, week 18, and week 24.

Conditions

Depression

Keywords

Yoga-based Intervention; Behavioral Activation

Outcome Measures

Primary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  Week: 0

• Patient Health Questionnaire-9 (PHQ-9)

  It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  Week: 6

• Patient Health Questionnaire-9 (PHQ-9)

  It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  Week:12

• Patient Health Questionnaire-9 (PHQ-9)

  It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  Week:18

• Patient Health Questionnaire-9 (PHQ-9)

  It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  Week: 24

Secondary Outcomes (3)

• World Health Organization-5 Well-Being Index (WHO-5)

  Week: 0, 6, 12, 18, 24

• PROMIS-29 Anxiety Subscale

  Week: 0, 6, 12, 18, 24

• PROMIS-29 Sleep Subscale

  Week: 0, 6, 12, 18, 24

Other Outcomes (4)

• PROMIS Anger

  Week: 0, 6, 12, 18, 24

• PROMIS-29 Physical Functioning Subscale

  Week: 0, 6, 12, 18, 24

• PROMIS-29 Social Functioning Subscale

  Week: 0, 6, 12, 18, 24

Study Arms (2)

Yoga-based Intervention

ACTIVE COMPARATOR

Yoga classes will be gentle and physically accessible for people who are naïve to yoga. Teachers will frequently guide participants to focus on their breathing and coordinate movements with breath. Teachers will offer variations on the postures and encourage participants to choose variations that provide some challenge but do not cause strain or pain. Classes will be 1 hour long and include a brief sitting meditation, warm-ups, standing postures, and a final resting meditation. All participants will be invited to attend a synchronous yoga class via a HIPAA-compliant videoconference option once per week during the first 3 months of the study. Classes will be offered at multiple times throughout the week.

Other: Online- Yoga-based Intervetion

Behavioral Activation

ACTIVE COMPARATOR

The goal of Behavioral Activation Psychotherapy is to help people identify and (re)engage in meaningful and positive activities through psychoeducation, identification of values and associated activities, goal setting, problem-solving, and monitoring of goal completion. There will be a BA manual for therapists and training provided by study staff on the manual (e.g., asynchronous and synchronous training sessions). BA therapists will be community clinicians. BA will be provided individually via telehealth and will be billed to participant insurance. At the start of BA treatment, participants will be oriented to the time-limited nature of BA, with the expectation that they will attend 8 sessions over the course of 3 months.

Behavioral: Online- BA

Interventions

Online- Yoga-based Intervetion OTHER

See arms description

Yoga-based Intervention

Online- BA BEHAVIORAL

See arms description

Behavioral Activation

Eligibility Criteria

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

You may qualify if:

• Aged 18 years old or older
• Depressive symptoms at study entry (PHQ-9≥10)
• Provides informed consent
• Able to read and understand English or Spanish.
• Live in NC, MA, MN, or RI
• Has a healthcare provider (a primary care provider, clinic, or mental health care provider) whom the participant could contact if medical care were needed

You may not qualify if:

• PHQ-9 \> 20
• A bone fracture or joint surgery in the past 6 months
• Unable to walk
• Severe heart failure or lung disease
• Had a healthcare provider tell them it is unsafe to exercise
• Currently pregnant
• Are already engaged in study interventions (i.e., engaged in yoga practice or psychotherapy more than once in the past 4 weeks or has an intake scheduled for psychotherapy in the next 4 weeks).
• Have active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to CSSR-S screener items 3, 4, 5, or 6 \[Past 3 months\])
• Are currently experiencing manic symptoms (Altman Self-Rating Mania Scale score ≥ 6)
• Unable to complete study procedures (i.e., attend yoga classes, BA sessions)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Butler Hospital: collaborator
• Hennepin Healthcare Research Institute: collaborator
• Medical University of South Carolina: collaborator
• Brown University: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Giuliana Chau

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Louisa Sylvia, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Lisa Uebelacker, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: February 13, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)