Teenthrive 2: Treatments for Improving Mood in Teens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Credibility
研究概览
简要总结
In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites.
详细描述
In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites. We will examine preliminary outcomes of depression, functional impairment, and anxiety, as well as engagement of hypothesized mechanisms of self-compassion, and metacognitive awareness. Participants will be adolescents with depression who will receive their assigned intervention for 3 months and be followed for 3 additional months. Parents will also be invited to participate in assessments regarding their child. Adolescent participants will be comprised of Set A (n=72) vs. Set B (where Set B participants do not meet Set A criteria for severity of depression symptoms or stability of other depression treatment. For both sets, in-person CBT groups and the yoga intervention will occur on the campus of the study hospital site. Randomization will be stratified by site and by set (A/B). Masked evaluators will assess depression symptom severity, which will be the primary outcome in a future fully-powered effectiveness trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Set A Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 10 or higher on the Quick Inventory of Depression-Adolescent Version-Clinician Rating (QIDS-A-CR), including either sad mood or anhedonia;
- •Be aged 12-18;
- •Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);
- •Be able to read and write in English;
- •Provide consent/assent appropriate to age;
- •Be able to attend group session times:
- •Have access to a private space once per week that is suitable for synchronous intervention sessions.
排除标准
- •Adolescents will be excluded if they:
- •Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;
- •Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
- •Have severe depression (QIDS-A-CR score > = 16);
- •Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
- •Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
- •Are pregnant;
- •Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
- •Have had substantive changes in other psychiatric treatment in the previous 4 weeks (e.g., started a new depression medication; stopped or started attending psychotherapy).
- •Have a sibling or other household member active in a study intervention (for this study) at the same time.
- •Set B Eligibility criteria
- •Participants who are not eligible for Set A may be enrolled in Phase 2 Set B, such that they will be eligible to attend classes but their data will not be considered in our main analyses.
- •Set B Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 6 or higher on the Quick Inventory of Depression-Adolescent Version-Clinician Rating (QIDS-A-CR), including either sad mood or anhedonia;
- •Be aged 12-18;
- •Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);
- •Be able to read and write in English;
- •Provide consent/assent appropriate to age;
- •Be able to attend group session times:
- •Have access to a private space once per week that is suitable for synchronous intervention sessions.
- •Set B Exclusion criteria: Adolescents will be excluded if they:
- •Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;
- •Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
- •Have severe depression (QIDS-A-CR score > = 16);
- •Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
- •Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
- •Are pregnant;
- •Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
- •Have a sibling or other household member active in a study intervention (for this study) at the same time.
研究组 & 干预措施
gCBT arm
group CBT
干预措施: group CBT (Behavioral)
Yoga arm
Yoga-based intervention
干预措施: Yoga-Based Intervention (Behavioral)
结局指标
主要结局
Credibility
时间窗: Start of treatment
Assessed by Credibility scale of Credibility Expectancy Questionnaire
Expectancy
时间窗: Start of treatment
Assessed by Expectancy scale of Credibility Expectancy Questionnaire
Program Satisfaction
时间窗: 12 weeks
Assessed by the Client Satisfaction Questionnaire (CSQ-8)
Class Attendance
时间窗: Week 0-12
Assessed via staff observation
次要结局
未报告次要终点