Overview

This trial has been completed.

Conditions anger, stress disorders, post-traumatic
Treatments anger management therapy, anger management therapy & relax app
Phase phase 1/phase 2
Sponsor VA Pacific Islands Health Care System
Collaborator United States Department of Defense
Start date March 2014
End date December 2015
Trial size 58 participants
Trial identifier NCT02132793, W81XWH-12-C-0067

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
anger management therapy
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
(Experimental)
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.
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.

Primary Outcomes

Measure
Dimensions of Anger Reactions (DAR-5)
time frame: up to 3 month follow-up

Secondary Outcomes

Measure
State-Trait Anger Expression Inventory-2 (STAXI-2)
time frame: Immediate post treatment and 3 month follow-up

Eligibility Criteria

Male participants at least 18 years old.

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), AUDIT, and the DAST - 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

Additional Information

Official title Remote Exercise for Learning Anger and Excitation Management (RELAX)
Principal investigator Margaret-Anne Mackintosh, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by VA Pacific Islands Health Care System.