AngerRELAXNCT02132793
Remote Exercise for Learning Anger and Excitation Management
A study testing Anger Management Therapy and Anger Management Therapy & RELAX app in people with Anger and Stress Disorders, Post-Traumatic, run by VA Pacific Islands Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anger, Stress Disorders, Post-Traumatic
- What is being tested?
- Anger Management Therapy and Anger Management Therapy & RELAX app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pacific Islands Healthcare System
Honolulu, Hawaii, 96819
About this study
Official title: 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.
Read the 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.
- Conditions
- Anger, Stress Disorders, Post-Traumatic
- Being tested
- Anger Management Therapy, Anger Management Therapy & RELAX app
- Keywords
- technology, mobile, anger management, anger, PTSD, veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anger Management TherapyBehavioural
Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
Anger Management Therapy & RELAX appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Anger Management Therapy | Active comparator | Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment. Receives: 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. Receives: Behavioral: Anger Management Therapy & RELAX app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 month follow-up
Secondary outcomes (1)
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.
Measured: Immediate post treatment and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pacific Islands Health Care System
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, Charles River Analytics
- Responsible party
- Sponsor
- Investigators
- Margaret-Anne Mackintosh, Ph.D., Principal investigator, VA Pacific Islands Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132793
- Sponsor's protocol ID
- W81XWH-12-C-0067
- Acronym
- RELAX
- Status last verified
- Nov 2016
- First submitted
- 5 May 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Exercise for Learning Anger and Excitation Management (RELAX)
- ClinicalTrials.gov ID
- NCT02132793
- Acronym / sponsor ID
- RELAX / W81XWH-12-C-0067
- Conditions
- Anger, Stress Disorders, Post-Traumatic
- Keywords
- technology, mobile, anger management, anger, PTSD, veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- VA Pacific Islands Health Care SystemUS federal agency
- Collaborators
- United States Department of Defense, Charles River Analytics
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anger Management Therapy | Active comparator | Behavioral: Anger Management TherapyAnger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment. |
| Anger Management Therapy & RELAX app | Experimental | Behavioral: Anger Management Therapy & RELAX appAnger 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anger Management TherapyAnger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment. | Behavioural | Anger Management Therapy |
| Anger Management Therapy & RELAX appAnger 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. | Behavioural | Anger Management Therapy & RELAX app |
Primary outcome
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.
1 secondary outcome
State-Trait Anger Expression Inventory-2 (STAXI-2)
Time frame: Immediate post treatment and 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret-Anne Mackintosh, Ph.D. principal investigator
VA Pacific Islands Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anger Management Therapy and Anger Management Therapy & RELAX app in people with Anger and Stress Disorders, Post-Traumatic, run by VA Pacific Islands Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensions of Anger Reactions (DAR-5) (time frame: up to 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.