Remote Exercise for Learning Anger and Excitation Management (RELAX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Dimensions of Anger Reactions (DAR-5)
研究概览
简要总结
The immediate objective of this project was to demonstrate the feasibility of Remote Exercises for Learning Anger and Excitation Management (RELAX). The application is a remote, technology- enabled, anger treatment and management system based on current evidence-based CBT interventions. The project's objective was to show that RELAX (1) enables the practice of anger management strategies remotely through mobile phone interfaces; (2) integrates with evidence-based treatments through the implementation of an existing CBT anger management course; (3) provides information, direction, and feedback through physiological sensors and signal analysis; and (4) supports communication and direction by the therapist through a web-based therapist interface.
详细描述
This project conducted a cognitive behavioral therapy (CBT) anger management treatment groups with a Veteran population using the RELAX application, collected weekly feedback from participants, and collaborate with the Sponsor to document initial efficacy, feasibility, and safety of the RELAX system. Outcome domains included: 1) clinical outcomes (symptom severity, social functioning); 2) process outcomes (perception of treatment, satisfaction, group therapy alliance, treatment compliance, and attrition and treatment credibility); and (3) Technical feasibility of the RELAX application. Study clinicians were 1) trained to conduct baseline and follow-up assessments 2) trained to conduct the standardized Anger Management Therapy (AMT) protocol at acceptable levels of adherence and competence and 3) trained how to use the technology and how to respond to technical difficulties. Study clinicians tested the feasibility of the RELAX application and showed that it can be integrated with CBT anger management therapies and support therapist communication through the technology.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •a score of 20 or higher on the 10-item Trait Scale of the STAXI
- •participants taking psychoactive medications have to have a stable regimen for at least 45 days prior to study entry
- •participants must be able to read, understand, and sign the consents themselves and be willing and able to comply with all study related procedures
排除标准
- •active psychotic symptoms/disorder as determined by the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual of Mental Disorders(DSM)
- •active homicidal or suicidal ideation as determined by the SCID
- •any significant cognitive impairment or history of Organic Mental Disorder as determined by the SCID
- •active (current) substance dependence as determined by the SCID (lifetime substance dependence or substance abuse not excluded)
- •unwillingness to refrain from substance abuse during treatment
- •female Veterans
- •vulnerable persons such as those described in the section Ethical Considerations and Regulatory Issues, Vulnerable Population
研究组 & 干预措施
Anger Management Therapy
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
干预措施: Anger Management Therapy (Behavioral)
Anger Management Therapy & RELAX app
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment. RELAX app (1) enables the practice of anger management strategies remotely through mobile phone interfaces; (2) integrates with evidence-based treatments through implementing an existing CBT anger management course; (3) provides information, direction, and feedback through physiological sensors; and (4) supports communication and direction by the therapist through a web-based therapist interface and a remote and secure patient data server.
干预措施: Anger Management Therapy & RELAX app (Behavioral)
结局指标
主要结局
Dimensions of Anger Reactions (DAR-5)
时间窗: up to 3 month follow-up
The DAR-5 is a reliable and valid screening measure of common anger reactions. Its brevity is useful for rapidly assessing the presence of anger problems in different populations. The strength of the DAR-5 is that it employs a minimum number of items to measure the anger construct. Item content pertains to anger frequency, intensity, duration, interpersonal aggressiveness, and the extent to which anger interferes with interpersonal relationships.
次要结局
- State-Trait Anger Expression Inventory-2 (STAXI-2)(Immediate post treatment and 3 month follow-up)