Teenthrive 2: Treatments for Improving Mood in Teens

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Yoga-Based Intervention
  This intervention consists of twice-weekly yoga classes. Classes will be led by trained yoga teachers. Each week for 12 weeks, classes will occur once in person (55 mins) and once virtually (30 mins).
• Поведенческое group CBT
  This intervention consists of twice-weekly group CBT sessions. Sessions will be led by trained behavioral health specialists. Each week for 12 weeks, sessions will occur once in person (55 mins) and once virtually (30 mins).

Первичные конечные точки

• Credibility [Срок оценки: Start of treatment]
• Expectancy [Срок оценки: Start of treatment]
• Program Satisfaction [Срок оценки: 12 weeks]
• Class Attendance [Срок оценки: Week 0-12]

Критерии участия

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.

Set A 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 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• Beth Israel Deaconess Medical Center — Boston
• Nationwide Children's Hospital — Columbus

Идентификаторы

NCT: NCT07475845 · 2312-001 · R01AT012238

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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