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
- 11
- 试验地点
- 2
- 主要终点
- Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
研究概览
简要总结
Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention
详细描述
In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week adapted hatha yoga intervention.
the investigators will enroll 12 adolescents in the open pilot trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adolescents must have elevated depressive symptoms, defined by a score of 11 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 12 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
- •QIDS- A-CR may not be higher than a score of
- •This ensures that adolescents are not severely depressed.
- •Adolescents who meet criteria for:
- •Current (past year) autism spectrum disorder (AS), if of sufficient severity to interfere with study treatment per clinician judgment;
- •Schizophrenia;
- •Bipolar disorder;
- •Clinically significant psychotic symptoms in the past month;
- •Anorexia or Bulimia in past 3 months
- •Substance use disorders in the 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 current suicide ideation or behavior that warrants immediate treatment. They may have passive ideation (i.e., thoughts that life is not worth living), but may not have active suicide ideation, intent, plan, or an attempt within the previous 6 months.
- •Adolescents cannot currently be engaged in or 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 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: Post intervention (month 3)
Acceptability assessed based on number of participants who remained in the intervention (retention).
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 scored on a range of 0-1. 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.
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.
次要结局
- Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)(post intervention (month 3))