Remote Exercise for Learning Anger and Excitation Management

Stress Disorders, Post-Traumatic Clinical Trial

— RELAX  

Official title:

Remote Exercise for Learning Anger and Excitation Management (RELAX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132793
• Other study ID #: W81XWH-12-C-0067
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: October 31, 2017
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: VA Pacific Islands Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anger
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	VA Pacific Islands Healthcare System	Honolulu	Hawaii

Sponsors (3)

Lead Sponsor	Collaborator
VA Pacific Islands Health Care System	Charles River Analytics, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PTSD Checklist (PCL-5)	The PCL will be used as an additional measure of PTSD symptoms. The PCL has been found to be a reliable and valid self-report measure of PTSD. Respondents indicate the degree to which they have been bothered by each of the 17 PTSD symptoms during the past month on a 5-point Likert scale, and item scores are summed.	Immediate post treatment and 3 month follow-up
Primary	Dimensions of Anger Reactions (DAR-5)	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.	up to 3 month follow-up
Secondary	State-Trait Anger Expression Inventory-2 (STAXI-2)	The STAXI-2 is a revised and expanded version of the original STAXI. The measure consists of items assessing the intensity of anger as an emotional state (State Anger) and the tendency of an individual to experience state anger, or anger proneness (Trait Anger). The Trait Anger scale measures individual differences in the disposition to experience anger. The Anger Expression scale provides an index of the frequency of anger expression. The STAXI has demonstrated strong reliability and validity.	Immediate post treatment and 3 month follow-up

External Links

•   The Substance Abuse and Mental Health Services Administration (SAMHSA) is a branch of the U.S. Department of Health and Human Services.