Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Treatment Skill Practice
研究概览
简要总结
Although cognitive-behavioral therapy (CBT) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression), a significant limitation to the CBT's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. Mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. This study examines whether a mobile application-enhanced CBT can improve participant adherence and treatment acceptance for adolescents at high risk for SMD.
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 (Participant)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-5 criteria for at least one past major depressive disorder, persistent depressive disorder, or unspecified bipolar disorder
- •Be 13-17 years old
- •English speaking and able to complete written questionnaires
- •Ability to attend pre-determined group session time(s)
- •Access to a smartphone to engage with the study app
- •Medication usage is acceptable, but not required
排除标准
- •Regular use or current abuse of a psychoactive drug
- •Evidence of behavioral problems that are thought to interfere with group treatment
- •Suicidality that requires more intensive treatment
- •Meeting DSM 5 criteria for bipolar I or II disorder, a psychotic disorder, or significant psychiatric symptoms (e.g., self-injurious behavior) that require more intensive treatment
- •Concurrent participation in cognitive-behavioral therapy
- •Inability to travel to study sessions and assessments
结局指标
主要结局
Treatment Skill Practice
时间窗: 9-week treatment period
Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report).
Psychosocial Treatment Compliance Scale
时间窗: 9-week treatment
Clinician-rated of participant overall treatment compliance. Scores range from 17-85 (17 5-point Likert scale items) with higher scores indicating greater treatment compliance.
Mobile Application Use
时间窗: 9-week treatment period
Frequency of mobile application (app) usage within the condition that received the mobile application, ranging from 0 to unlimited maximum with higher scores indicating more app usage.
次要结局
- Mobile Application Usability Scale(Measured at the end of the 9-week treatment period)
- Children's Depression Rating Scale, Revised(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- Young Mania Rating Scale(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- Clinical Global Assessment Scale(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- Clinical Global Impression(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- Symptom Checklist 90(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- Difficulties With Emotion Regulation(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- KINDL(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
- Depression Anxiety & Stress Scale(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
研究者
Marc J. Weintraub, PhD
Principal Investigator
University of California, Los Angeles