DepressionNCT05546697

Comparing Behavior Therapy and Yoga for Treating Depression Among Adults

A study testing Online- Yoga-based Intervetion and Online- BA in people with Depression, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: Online- Yoga-based Intervetion and Online- BA
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 520 participants
Where: 1 siteUnited States
Study dates: 13 Feb 2023to 18 May 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Giuliana Chau
Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Depression
Being tested: Online- Yoga-based Intervetion, Online- BA
Keywords: Yoga-based Intervention, Behavioral Activation
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Online- Yoga-based IntervetionOther
See arms description
Online- BABehavioural
See arms description

Study groups in NCT05546697
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Online- BA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week: 24

Secondary outcomes (3)

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.
Measured: Week: 0, 6, 12, 18, 24
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.
Measured: Week: 0, 6, 12, 18, 24
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.
Measured: Week: 0, 6, 12, 18, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 202318 May 2026

First posted21 Sep 2022
Study start13 Feb 2023
Primary completion18 May 2026
Study completion18 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05546697
Sponsor's protocol ID: 2022P001701
Status last verified: Jun 2026
First submitted: 14 Sep 2022
Last updated: 15 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COMPARE: Comparing Behavior Therapy and Yoga for Treating Depression Among Adults
ClinicalTrials.gov ID: NCT05546697
Acronym / sponsor ID: 2022P001701
Conditions: Depression
Keywords: Yoga-based Intervention, Behavioral Activation
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Butler Hospital, Hennepin Healthcare Research Institute, Medical University of South Carolina, Brown University, Wake Forest University Health Sciences
Study start: 13 Feb 2023 (actual)
Primary completion: 18 May 2026 (actual)
Study completion: 18 May 2026 (actual)
First posted: 21 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Yoga-based Intervention	Active comparator	Other: Online- Yoga-based IntervetionYoga 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.
Behavioral Activation	Active comparator	Behavioral: Online- BAThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Online- Yoga-based IntervetionSee arms description	Other	Yoga-based Intervention
Online- BASee arms description	Behavioural	Behavioral Activation

Primary outcome

Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week: 0
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week: 6
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week:12
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week:18
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week: 24
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.

3 secondary outcomes

World Health Organization-5 Well-Being Index (WHO-5)
Time frame: Week: 0, 6, 12, 18, 24
PROMIS-29 Anxiety Subscale
Time frame: Week: 0, 6, 12, 18, 24
PROMIS-29 Sleep Subscale
Time frame: Week: 0, 6, 12, 18, 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Louisa Sylvia, PhD principal investigator

Massachusetts General Hospital

Lisa Uebelacker, PhD principal investigator

Butler Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Online- Yoga-based Intervetion and Online- BA in people with Depression, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (PHQ-9) (time frame: Week: 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05546697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.