- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132793
Remote Exercise for Learning Anger and Excitation Management (RELAX)
October 31, 2017 updated by: VA Pacific Islands Health Care System
Remote Exercise for Learning Anger and Excitation Management (RELAX)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hawaii
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Honolulu, Hawaii, United States, 96819
- VA Pacific Islands Healthcare System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Immediate post treatment and 3 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Immediate post treatment and 3 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Margaret-Anne Mackintosh, Ph.D., VA Pacific Islands Healthcare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
May 5, 2014
First Submitted That Met QC Criteria
May 6, 2014
First Posted (Estimate)
May 7, 2014
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
October 31, 2017
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- W81XWH-12-C-0067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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