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| Name | Class |
|---|---|
| Butler Hospital | OTHER |
| Hennepin Healthcare Research Institute | OTHER |
| Medical University of South Carolina | OTHER |
| Brown University |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online- Yoga-based Intervetion | Other | See arms description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PROMIS-29 Physical Functioning Subscale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louisa Sylvia, PhD | Massachusetts General Hospital | Principal Investigator |
| Lisa Uebelacker, PhD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Giuliana Chau | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| OTHER |
| Wake Forest University Health Sciences | OTHER |
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| Online- BA |
| Behavioral |
See arms description |
|
| Week: 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. | 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. | Week: 0, 6, 12, 18, 24 |
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 |
| 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 |
| 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 |