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Completed

NCT Number: NCT02132793

Remote Exercise for Learning Anger and Excitation Management

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.

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Key information

Conditions

Anger Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

VA Pacific Islands Healthcare System

Honolulu, Hawaii, 96819, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anger management therapy

Behavioral

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

Anger Management Therapy & RELAX app

Behavioral

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

  1. Dimensions of Anger Reactions (DAR-5)

    Time frame: 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.

Secondary outcomes

  1. State-Trait Anger Expression Inventory-2 (STAXI-2)

    Time frame: Immediate post treatment and 3 month follow-up

    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.

Other outcomes

  1. PTSD Checklist (PCL-5)

    Time frame: Immediate post treatment and 3 month follow-up

    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.

Sponsors and collaborators

Lead sponsor

VA Pacific Islands Health Care System

Fed

Collaborators

  • Charles River Analytics
  • United States Department of Defense

Registry information

Official study title

Remote Exercise for Learning Anger and Excitation Management (RELAX)

Acronym: RELAX

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 7, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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