Remote Exercise for Learning Anger and Excitation Management

NCT02132793 | Completed

• 1 other identifier: W81XWH-12-C-0067
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Anger; Stress Disorders, Post-Traumatic

Keywords

technology; mobile; anger management; anger; PTSD; veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State-Trait Anger Expression Inventory-2 (STAXI-2)

  Immediate post treatment and 3 month follow-up

Other Outcomes (1)

• PTSD Checklist (PCL-5)

  Immediate post treatment and 3 month follow-up

Study Arms (2)

Anger Management Therapy

ACTIVE COMPARATOR

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

Behavioral: Anger Management Therapy

Anger Management Therapy & RELAX app

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.

Behavioral: Anger Management Therapy & RELAX app

Interventions

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

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.

Anger Management Therapy & RELAX app

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Pacific Islands Health Care System: lead
• United States Department of Defense: collaborator
• Charles River Analytics: collaborator

Study Sites (1)

VA Pacific Islands Healthcare System

Honolulu, Hawaii, 96819, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Anger Management Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Margaret-Anne Mackintosh, Ph.D.

  VA Pacific Islands Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: November 6, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)