Clinical trial NCT02132793: Remote Exercise for Learning Anger and Excitation Management
Official title: Remote Exercise for Learning Anger and Excitation Management (RELAX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anger
Stress Disorders, Post-Traumatic
Keywords: technology
mobile
anger management
anger
PTSD
veterans
Lead sponsor: VA Pacific Islands Health Care System
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: Charles River Analytics
First posted: 2014-05-07
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dimensions of Anger Reactions (DAR-5)
timeFrame: up to 3 month follow-up
Secondary outcomes:
measure: State-Trait Anger Expression Inventory-2 (STAXI-2)
timeFrame: Immediate post treatment and 3 month follow-up
Other outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: Immediate post treatment and 3 month follow-up
Locations:
city: Honolulu
country: United States
facility: VA Pacific Islands Healthcare System
state: Hawaii
Study officials:
affiliation: VA Pacific Islands Healthcare System
name: Margaret-Anne Mackintosh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: