Expanding First-line Options for Depression and Matching Treatments to Patients: Hatha Yoga vs. Behavioral Therapy

Depression Clinical Trial

Official title:

COMPARE: Expanding First-line Options for Depression and Matching Treatments to Patients: Hatha Yoga vs. Behavioral Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546697
• Other study ID #: 2022P001701
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: Antonietta H Alvarez, BA
• Phone: 6176430857
• Email: aalvarezhernandez[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 518
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Online- Yoga-based Intervetion
See arms description

Behavioral:
• Online- BA
See arms description

Locations

Country	Name	City	State
United States	Antonietta Alvarez Hernandez	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brown University, Butler Hospital, Hennepin Healthcare Research Institute, Medical University of South Carolina, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS Anger	It is a 5-item self-report scale used to assess the exploratory outcome of irritability. PROMIS scores of 5, 10, 15, 20, and 25 represented minimal, mild, moderate, moderately severe, and severe anger, respectively.	Week: 0, 6, 12, 18, 24
Other	PROMIS-29 Physical Functioning Subscale	Part of the PROMIS-29 scale which has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) with four items in this domain. PROMIS scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe physical function, respectively. It has demonstrated good psychometric properties.	Week: 0, 6, 12, 18, 24
Other	PROMIS-29 Social Functioning Subscale	Part of the PROMIS-29 scale which has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) with four items in this domain. PHQ-9 scores of 5, 10, 15, and 20 represented severe, moderately severe, moderate, and mild physical functioning, respectively. It has demonstrated good psychometric properties.	Week: 0, 6, 12, 18, 24
Other	PROMIS-29 Pain Interference	Part of the PROMIS-29 scale which has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) with four items in this domain. PROMIS scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe pain interference, respectively. It has demonstrated good psychometric properties.	Week: 0, 6, 12, 18, 24
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	World Health Organization-5 Well-Being Index (WHO-5)	It is a 5-item self-report questionnaire with positively-worded statements related to positive mood, vitality, and general interest over the prior two weeks. The WHO-5 is reliable, has shown strong construct validity as a measure of general quality of life, and is sensitive to change.	Week: 0, 6, 12, 18, 24
Secondary	PROMIS-29 Anxiety Subscale	Part of the PROMIS-29 scale which has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) with four items in this domain. PROMIS scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe anxiety, respectively. It has demonstrated good psychometric properties.	Week: 0, 6, 12, 18, 24
Secondary	PROMIS-29 Sleep Subscale	Part of the PROMIS-29 scale which has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) with four items in this domain. PROMIS scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe sleep disturbance respectively. It has demonstrated good psychometric properties.	Week: 0, 6, 12, 18, 24