Remote Exercise for Learning Anger and Excitation Management (RELAX)

VA Pacific Islands Health Care System

Status: Completed

Conditions: Anger; Stress Disorders, Post-Traumatic

Treatments: Behavioral: Anger Management Therapy; Behavioral: Anger Management Therapy & RELAX app

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT02132793

W81XWH-12-C-0067

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

Anger Management Therapy

Active Comparator group

Description:

Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.

Treatment:

Behavioral: Anger Management Therapy

Anger Management Therapy & RELAX app

Experimental group

Description:

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.

Treatment:

Behavioral: Anger Management Therapy & RELAX app