ACTIVE_NOT_RECRUITING

Comparing Behavior Therapy and Yoga for Treating Depression Among Adults

Conditions

Depression Yoga-based Intervention Behavioral Activation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

COMPARE: Comparing Behavior Therapy and Yoga for Treating Depression Among Adults

Quick Facts

Study Start:2023-02-13

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05546697

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Aged 18 years old or older 2. Depressive symptoms at study entry (PHQ-9≥10) 3. Provides informed consent 4. Able to read and understand English or Spanish. 5. Live in NC, MA, MN, or RI 6. Has a healthcare provider (a primary care provider, clinic, or mental health care provider) whom the participant could contact if medical care were needed	1. PHQ-9 \> 20 2. A bone fracture or joint surgery in the past 6 months 3. Unable to walk 4. Severe heart failure or lung disease 5. Had a healthcare provider tell them it is unsafe to exercise 6. Currently pregnant 7. 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). 8. 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 \[Past 3 months\]) 9. Are currently experiencing manic symptoms (Altman Self-Rating Mania Scale score ≥ 6) 10. Unable to complete study procedures (i.e., attend yoga classes, BA sessions)

Inclusion Criteria

Exclusion Criteria

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

1. PHQ-9 \> 20
2. A bone fracture or joint surgery in the past 6 months
3. Unable to walk
4. Severe heart failure or lung disease
5. Had a healthcare provider tell them it is unsafe to exercise
6. Currently pregnant
7. 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).
8. 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 \[Past 3 months\])
9. Are currently experiencing manic symptoms (Altman Self-Rating Mania Scale score ≥ 6)
10. Unable to complete study procedures (i.e., attend yoga classes, BA sessions)

Contacts and Locations

Principal Investigator

Louisa Sylvia, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Lisa Uebelacker, PhD

PRINCIPAL_INVESTIGATOR

Butler Hospital

Study Locations (Sites)

Giuliana Chau

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Louisa Sylvia, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
Lisa Uebelacker, PhD, PRINCIPAL_INVESTIGATOR, Butler Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-13

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2023-02-13

Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

Yoga-based Intervention
Behavioral Activation

Additional Relevant MeSH Terms

Depression