COMPARE: Comparing Behavior Therapy and Yoga for Treating Depression Among Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 518
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
研究组 & 干预措施
Yoga-based Intervention
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.
干预措施: Online- Yoga-based Intervetion (Other)
Behavioral Activation
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.
干预措施: Online- BA (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- PROMIS-29 Sleep Subscale(Week: 0, 6, 12, 18, 24)
- World Health Organization-5 Well-Being Index (WHO-5)(Week: 0, 6, 12, 18, 24)
- PROMIS-29 Anxiety Subscale(Week: 0, 6, 12, 18, 24)
研究者
Louisa Grandin Sylvia
Associate Director
Massachusetts General Hospital