Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
研究概览
简要总结
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
详细描述
In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of 12 weeks of hatha yoga vs. 12 weeks of group CBT.
Participants will be adolescents with depression. Parents will also be invited to participate in assessments regarding their child.
Study B, which will run concurrent to Phase 3, will be for participants who did not meet the depression inclusion criteria or had recent changes in therapy or medications that make them ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group participation.
Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT. Parents will also be invited to participate in assessments regarding their child.
* Due to social distancing requirements related to COVID-19, all interventions have been delivered remotely via video-based platforms as of late March 2020.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Please note, inclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical, with the exception that, for Phase 3/ Study B, we will not require elevated depressive symptoms (a) or stable treatment (b).
- •Adolescents must have elevated depressive symptoms, defined by a score of 10 or higher on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.
- •Other treatment for depression must be stable at baseline. Adolescents do not have to be in other treatment for depression, but, if they are, it must be stable for the past 8 weeks.
- •Adolescents must be aged 13-
- •Adolescents must be medically cleared for moderate physical activity by their primary care physician. This criterion may be met by a current (dated in the past year) statement from their pediatrician that the adolescent may participate in school or camp programs including physical education.
- •Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
- •Adolescents aged 13-17 must assent to be in the study, and their parent or legal guardian must consent to their participation. Adolescents aged 18 must consent to be in the study.
- •Able to attend one of the class times.
排除标准
- •Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.
- •QIDS- A-CR may not be higher than a score of
- •This ensures that adolescents are not severely depressed.
- •Adolescents may not meet criteria for the following:
- •Autism spectrum disorder "cannot be ruled out", and symptoms are of sufficient severity to interfere with study treatment per clinician judgement
- •Current psychotic disorder
- •Lifetime history of a manic episode
- •Anorexia or Bulimia in past 3 months
- •Substance use disorders in past 12 months, and symptoms are of sufficient severity to interfere with study treatment per clinician judgment These will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
- •Adolescents may not have suicide ideation so severe it will interfere with study participation.
- •Adolescents cannot currently be engaged in yoga classes, as this is the study intervention.
- •Adolescents cannot be pregnant as yoga should be modified for pregnancy.
结局指标
主要结局
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
时间窗: Week 1
Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 and the mean of those scores are analyzed, with higher scores indicating greater expectations.
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
时间窗: Post intervention (month 3)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
Acceptability
时间窗: 12 weeks
Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.
Home Practice Questionnaire
时间窗: Post intervention (month 3)
Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
时间窗: Week 1
Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are each scored on a range of 0-1, and the mean of thise is used in analyses. Higher scores indicate greater credibility.
The Client Satisfaction Questionnaire (CSQ-8)
时间窗: Post intervention (month 3)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
次要结局
- Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)(Baseline to post intervention (month 3))