Back to resultsRemote Exercise for Learning Anger and Excitation Management (RELAX)
Primary Purpose
Anger, Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anger Management Therapy
Anger Management Therapy & RELAX app
Sponsored by
About this trial
This is an interventional treatment trial for Anger focused on measuring technology, mobile, anger management, anger, PTSD, veterans
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
Sites / Locations
- VA Pacific Islands Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Anger Management Therapy
Anger Management Therapy & RELAX app
Arm Description
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02132793
First Posted
May 5, 2014
Last Updated
October 31, 2017
Sponsor
VA Pacific Islands Health Care System
Collaborators
United States Department of Defense, Charles River Analytics
1. Study Identification
Unique Protocol Identification Number
NCT02132793
Brief Title
Remote Exercise for Learning Anger and Excitation Management
Acronym
RELAX
Official Title
Remote Exercise for Learning Anger and Excitation Management (RELAX)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Pacific Islands Health Care System
Collaborators
United States Department of Defense, Charles River Analytics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Stress Disorders, Post-Traumatic
Keywords
technology, mobile, anger management, anger, PTSD, veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anger Management Therapy
Arm Type
Active Comparator
Arm Description
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
Arm Title
Anger Management Therapy & RELAX app
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Anger Management Therapy
Intervention Description
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
Intervention Type
Behavioral
Intervention Name(s)
Anger Management Therapy & RELAX app
Intervention Description
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 Outcome Measure Information:
Title
Dimensions of Anger Reactions (DAR-5)
Description
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.
Time Frame
up to 3 month follow-up
Secondary Outcome Measure Information:
Title
State-Trait Anger Expression Inventory-2 (STAXI-2)
Description
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.
Time Frame
Immediate post treatment and 3 month follow-up
Other Pre-specified Outcome Measures:
Title
PTSD Checklist (PCL-5)
Description
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.
Time Frame
Immediate post treatment and 3 month follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret-Anne Mackintosh, Ph.D.
Organizational Affiliation
VA Pacific Islands Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pacific Islands Healthcare System
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.samhsa.gov/
Description
The Substance Abuse and Mental Health Services Administration (SAMHSA) is a branch of the U.S. Department of Health and Human Services.
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Remote Exercise for Learning Anger and Excitation Management
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