Clinical trial NCT05546697: Expanding First-line Options for Depression and Matching Treatments to Patients: Hatha Yoga vs. Behavioral Therapy
Official title: COMPARE: Expanding First-line Options for Depression and Matching Treatments to Patients: Hatha Yoga vs. Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Yoga-based Intervention
Behavioral Activation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Butler Hospital
name: Hennepin Healthcare Research Institute
name: Medical University of South Carolina
name: Brown University
name: Wake Forest University Health Sciences
First posted: 2022-09-21
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The first goal of the proposed research is to determine whether a hatha yoga program for depression is non-inferior to BA in reducing depressive symptoms over a 6-month period.

Our second goal is to identify individual-level characteristics that predict heterogeneity of treatment effect (HTE) to develop guidance for matching patients to the optimal depression treatment.

Sample- Our sample will be representative of the target population: individuals with depression. There are several aspects of the current study design that the investigators believe will enhance recruitment in diverse patient populations.

* Both study interventions will be offered via telehealth to reduce barriers to access (e.g., childcare, time, parking/transportation costs, less time out of work).
* The investigators have study funds to cover the costs of the technology for people who do not have a device or home-based internet access. Further, to decrease barriers related to digital literacy, study staff will be proactive about assisting participants with setting up technology, using technology and troubleshooting if needed.
* The investigators have study funds to pay for the BA therapists for participants who are uninsured.
* The investigators have study funds to offer the yoga intervention free of charge to participants.
* The investigators will offer study participation to Spanish-speakers.
* The investigators have an Advisory Board of stakeholders with diverse backgrounds (i.e., racially and ethnically diverse as well as diversity in socioeconomic status, educational background, and clinical features) to assist with the implementation and oversight of this study.

Participants will be paid for completing study assessments, they will not be compensated for attending study intervention sessions.

Assessments occur at Baseline (week 0, prior to randomization), and weeks 6, 12, 18, and 24. All self-report assessments will be available in English or Spanish. When an assessment is due, participants will be sent an automated link to complete the assessments via REDCap. In addition, they will receive reminders if they do not complete the assessment, and, if needed, follow-up phone calls from study staff. It is expected that the assessments at Weeks 0 (baseline) and 24 (end of treatment) will take approximately 45 min to complete, at Week 12 will take approximately 30 min to complete and at Weeks 6 and 18 will take approximately 20 min to complete.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

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)

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week: 0
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week: 6
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week:12
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week:18
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week: 24
Secondary outcomes:
measure: World Health Organization-5 Well-Being Index (WHO-5)
timeFrame: Week: 0, 6, 12, 18, 24
measure: PROMIS-29 Anxiety Subscale
timeFrame: Week: 0, 6, 12, 18, 24
measure: PROMIS-29 Sleep Subscale
timeFrame: Week: 0, 6, 12, 18, 24
Other outcomes:
measure: PROMIS Anger
timeFrame: Week: 0, 6, 12, 18, 24
measure: PROMIS-29 Physical Functioning Subscale
timeFrame: Week: 0, 6, 12, 18, 24
measure: PROMIS-29 Social Functioning Subscale
timeFrame: Week: 0, 6, 12, 18, 24
measure: PROMIS-29 Pain Interference
timeFrame: Week: 0, 6, 12, 18, 24
Locations:
city: Boston
country: United States
facility: Giuliana Chau
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Louisa Sylvia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Lisa Uebelacker, PhD
role: PRINCIPAL_INVESTIGATOR
References: