Traumatic Brain InjuryASMTNCT01745146
Anger Self-Management in Traumatic Brain Injury
A study testing ASMT and PRE in people with Traumatic Brain Injury, run by Albert Einstein Healthcare Network at 3 sites in United States.
Trial summary
The present study addresses problematic anger and irritability in community dwelling persons with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment approach called Anger Self-Management Training (ASMT), compared to a treatment offering supportive therapy focused on personal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- ASMT and PRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 16 at the time of injury
- ages 18 to 65 at the time of enrollment
- TBI (closed or penetrating) occurring a minimum of 6 months prior to enrollment
- TBI documented as complicated mild, moderate, or severe TBI by any one or more of the following indices:
- post-resuscitation score on Glasgow Coma Scale (GCS) < 13 or GCS Motor < 6;
- loss of consciousness, unresponsiveness or coma attributable to the TBI and persisting ≥ 1 hour;
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- post-traumatic amnesia, or disorientation (O x 0, 1 or 2) attributable to the TBI and persisting ≥ 24 hours; or
- neuro-imaging study positive for TBI-related findings such as contusion, hematoma, hemorrhage, diffuse axonal injury, shear injury, and/ or depressed skull fracture
- Able to travel independently in the community (to maximize the probability that participants will be cognitively and physically able to engage in the treatment)
- Indication from self or other report that participant has problematic anger/ irritability that is new since the injury or worse than before the injury
- Self-report of anger ≥ 1 standard deviation above the mean for age and gender on the Trait Anger or Anger Expression-Out (AX-O) subscales of the State-Trait Anger Expression Inventory-2 (STAXI-2), or a score of ≥ 7 on the Brief Anger-Aggression Questionnaire (BAAQ)
- Able to speak and understand English sufficiently to complete the screening and outcome measures and to participate in a verbally based treatment program, which thus far exists only in English
- Informed consent given by participant or legally authorized representative.
Who cannot join
- History of schizophrenia or schizo-affective disorder, as documented in medical records or by self-report that a medical professional has given the diagnosis
- Current psychosis, major depression, or suicidal ideation; or history of manic or hypomanic episode as determined by the Mini-International Neuropsychiatric Interview for DSM-IV (MINI) Current alcohol-l dependence, as determined by the MINI.
- Self-reported use of cocaine or amphetamines "daily" or "almost daily" using the relevant questions from the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
- TBI requiring hospitalization that has occurred within 6 months prior to enrollment
- Involvement in one-to-one counseling or psychotherapy targeted to emotional health issues
- Involvement in another treatment trial that may affect participation or outcomes
- Evidence of severe, intractable anger as indicated by history of violence-related crimes, e.g., charges for assault.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Moss Rehabilitation Research Institue
Elkins Park, Pennsylvania, 19027
Craig Hospital
Englewood, Colorado, 80237
Data Cordinating Center
Englewood, Colorado, 80237
About this study
Official title: Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial
The present study addresses problematic anger and irritability in community dwelling persons with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment approach called Anger Self-Management Training (ASMT), compared to a treatment offering supportive therapy focused on personal readjustment and education, the PRE (Personal Readjustment and Education). The project is a 3-center randomized controlled trial employing equivalent therapist time and therapeutic structure in the delivery of treatment options. The overall aim is to evaluate the relative response rate and correlates of treatment response for the ASMT as compared to the PRE.
Read the detailed description
Problematic anger/ irritability is common, persistent, and difficult to treat after TBI, and has a broad impact on community and social function. Anger following TBI is related, in part, to deficits in executive function including impaired problem-solving and impaired self-monitoring. In this 2-group, 3-center clinical trial with masked outcome assessment, we will explore feasibility and efficacy of a manualized, 8-session individual treatment, Anger Self-Management Training (ASMT), compared to a treatment using non-specific ingredients of therapist attention, education, and psychological support (PRE).
The ASMT was designed to decrease subjective and objective anger and irritability following traumatic brain injury (TBI), using theoretically motivated "active ingredients." The ASMT focuses on 2 executive deficits implicated in anger post TBI, (1) self-awareness and self-monitoring and (2) problem-solving. Participants will be randomly assigned in 2:1 proportion to ASMT or PRE. The PRE treatment is manualized to the same degree as the ASMT, but focuses on educational and personal readjustment to injury rather than anger-specific strategy training.
The overall goals are to examine the effects of the ASMT compared to PRE on self-reported problematic anger, both 1 week and 2 months after treatment, and to assess the time course of treatment response during the treatment phase.
Specific Aims
- To examine the efficacy of ASMT compared to a control treatment (PRE) as measured by improvement from baseline to post-treatment on the State-Trait Anger Expression Inventory-Revised (STAXI-2) Trait Anger; STAXI-2 Anger Expression-Out; or the Brief Anger-Aggression Questionnaire (BAAQ) (primary outcome).
- To examine the trajectory of treatment response within the treatment phase of ASMT/ PRE as shown by a change on 1 or more of the target scales halfway through the treatment (i.e., after 4 of 8 sessions) for those participants who exhibited a positive response post treatment (as defined above).
- To examine the persistence of treatment effects 2 months after the end of the treatment phase.
- Conditions
- Traumatic Brain Injury
- Being tested
- ASMT, PRE
- Keywords
- traumatic brain injury, TBI, head injury, brain injury, Psych-educational treatment, Anger, irritability, anger management
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASMTBehavioural
8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions
PREBehavioural
8-session, individual, psycho-educational intervention based on principles of education and personal readjustment to TBI Significant other (friend or relative) invited to participate in 3 of 8 sessions
| Study group | Role | What they receive |
|---|---|---|
| Anger Self-Management Training (ASMT) | Experimental | 8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions Receives: Behavioral: ASMT |
| Personal Readjustment and Ed (PRE) | Active comparator | 8-session, individual, psycho-educational intervention based on principles of education and personal readjustment. Significant other (friend or relative) invited to participate in 3 of 8 sessions Receives: Behavioral: PRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
Participant report only. The State-Trait Anger Expression Inventory-Revised Trait Anger Scale (STAXI-2 TA) measures how often angry feelings are experienced and the Anger Expression-Out (STAXI-2 AX-O) Scale addresses the expression of anger toward other persons or objects in the environment. The Brief Anger-Aggression Questionnaire (BAAQ) is a 6-item self-report scale that measures frequency of "acting-out" symptoms of anger. Overall treatment response is defined as ≥ 1 standard deviation change in the direction of improvement from pre- to 10 wk post-treatment on any 1 of the three anger scales used. Analysis first done by including participants who did not complete the assessment as non-responders (labeled as "missing outcomes included" or "MOI"). Analysis done a second time only using participants who completed the assessment (labeled as "missing outcomes removed" or "MOR").
Measured: Baseline, 10 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tessa Hart, Albert Einstein Healthcare Network
- Investigators
- Tessa Hart, PhD, Principal investigator, Moss Rehabilitation Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745146
- Sponsor's protocol ID
- R01 ASMT HN4385
- Other IDs
- 1R01HD061400-01A2
- Acronym
- ASMT
- Status last verified
- Oct 2018
- First submitted
- 6 Dec 2012
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hart T, Vaccaro MJ, Hays C, Maiuro RD. Anger self-management training for people with traumatic brain injury: a preliminary investigation. J Head Trauma Rehabil. 2012 Mar-Apr;27(2):113-22. doi: 10.1097/HTR.0b013e31820e686c.
PubMed 21407088Hart T, Brockway JA, Maiuro RD, Vaccaro M, Fann JR, Mellick D, Harrison-Felix C, Barber J, Temkin N. Anger Self-Management Training for Chronic Moderate to Severe Traumatic Brain Injury: Results of a Randomized Controlled Trial. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):319-331. doi: 10.1097/HTR.0000000000000316.
PubMed 28520666
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial
- ClinicalTrials.gov ID
- NCT01745146
- Acronym / sponsor ID
- ASMT / R01 ASMT HN4385
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, TBI, head injury, brain injury, Psych-educational treatment, Anger, irritability, anger management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study addresses problematic anger and irritability in community dwelling persons with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment approach called Anger Self-Management Training (ASMT), compared to a treatment offering supportive therapy focused on personal readjustment and education, the PRE (Personal Readjustment and Education). The project is a 3-center randomized controlled trial employing equivalent therapist time and therapeutic structure in the delivery of treatment options. The overall aim is to evaluate the relative response rate and correlates of treatment response for the ASMT as compared to the PRE.
Detailed description
Problematic anger/ irritability is common, persistent, and difficult to treat after TBI, and has a broad impact on community and social function. Anger following TBI is related, in part, to deficits in executive function including impaired problem-solving and impaired self-monitoring. In this 2-group, 3-center clinical trial with masked outcome assessment, we will explore feasibility and efficacy of a manualized, 8-session individual treatment, Anger Self-Management Training (ASMT), compared to a treatment using non-specific ingredients of therapist attention, education, and psychological support (PRE).
The ASMT was designed to decrease subjective and objective anger and irritability following traumatic brain injury (TBI), using theoretically motivated "active ingredients." The ASMT focuses on 2 executive deficits implicated in anger post TBI, (1) self-awareness and self-monitoring and (2) problem-solving. Participants will be randomly assigned in 2:1 proportion to ASMT or PRE. The PRE treatment is manualized to the same degree as the ASMT, but focuses on educational and personal readjustment to injury rather than anger-specific strategy training.
The overall goals are to examine the effects of the ASMT compared to PRE on self-reported problematic anger, both 1 week and 2 months after treatment, and to assess the time course of treatment response during the treatment phase.
Specific Aims
- To examine the efficacy of ASMT compared to a control treatment (PRE) as measured by improvement from baseline to post-treatment on the State-Trait Anger Expression Inventory-Revised (STAXI-2) Trait Anger; STAXI-2 Anger Expression-Out; or the Brief Anger-Aggression Questionnaire (BAAQ) (primary outcome).
- To examine the trajectory of treatment response within the treatment phase of ASMT/ PRE as shown by a change on 1 or more of the target scales halfway through the treatment (i.e., after 4 of 8 sessions) for those participants who exhibited a positive response post treatment (as defined above).
- To examine the persistence of treatment effects 2 months after the end of the treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anger Self-Management Training (ASMT) | Experimental | Behavioral: ASMT8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions |
| Personal Readjustment and Ed (PRE) | Active comparator | Behavioral: PRE8-session, individual, psycho-educational intervention based on principles of education and personal readjustment. Significant other (friend or relative) invited to participate in 3 of 8 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 16 at the time of injury
- ages 18 to 65 at the time of enrollment
- TBI (closed or penetrating) occurring a minimum of 6 months prior to enrollment
- TBI documented as complicated mild, moderate, or severe TBI by any one or more of the following indices:
- Able to travel independently in the community (to maximize the probability that participants will be cognitively and physically able to engage in the treatment)
Key exclusion criteria (7 listed)
- History of schizophrenia or schizo-affective disorder, as documented in medical records or by self-report that a medical professional has given the diagnosis
- Current psychosis, major depression, or suicidal ideation; or history of manic or hypomanic episode as determined by the Mini-International Neuropsychiatric Interview for DSM-IV (MINI) Current alcohol-l dependence, as determined by the MINI.
- Self-reported use of cocaine or amphetamines "daily" or "almost daily" using the relevant questions from the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
- TBI requiring hospitalization that has occurred within 6 months prior to enrollment
- Involvement in one-to-one counseling or psychotherapy targeted to emotional health issues
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 |
|---|---|---|
| ASMT8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions | Behavioural | Anger Self-Management Training (ASMT) |
| PRE8-session, individual, psycho-educational intervention based on principles of education and personal readjustment to TBI Significant other (friend or relative) invited to participate in 3 of 8 sessions | Behavioural | Personal Readjustment and Ed (PRE) |
Primary outcome
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report
Time frame: Baseline, 10 weeks (post-treatment)
Participant report only. The State-Trait Anger Expression Inventory-Revised Trait Anger Scale (STAXI-2 TA) measures how often angry feelings are experienced and the Anger Expression-Out (STAXI-2 AX-O) Scale addresses the expression of anger toward other persons or objects in the environment. The Brief Anger-Aggression Questionnaire (BAAQ) is a 6-item self-report scale that measures frequency of "acting-out" symptoms of anger. Overall treatment response is defined as ≥ 1 standard deviation change in the direction of improvement from pre- to 10 wk post-treatment on any 1 of the three anger scales used. Analysis first done by including participants who did not complete the assessment as non-responders (labeled as "missing outcomes included" or "MOI"). Analysis done a second time only using participants who completed the assessment (labeled as "missing outcomes removed" or "MOR").
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21407088Hart T, Vaccaro MJ, Hays C, Maiuro RD. Anger self-management training for people with traumatic brain injury: a preliminary investigation. J Head Trauma Rehabil. 2012 Mar-Apr;27(2):113-22. doi: 10.1097/HTR.0b013e31820e686c.
- Results publication: PubMed 28520666Hart T, Brockway JA, Maiuro RD, Vaccaro M, Fann JR, Mellick D, Harrison-Felix C, Barber J, Temkin N. Anger Self-Management Training for Chronic Moderate to Severe Traumatic Brain Injury: Results of a Randomized Controlled Trial. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):319-331. doi: 10.1097/HTR.0000000000000316.
- Individual participant dataSharing planned: Undecided
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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.
Tessa Hart, PhD principal investigator
Moss Rehabilitation Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASMT and PRE in people with Traumatic Brain Injury, run by Albert Einstein Healthcare Network at 3 sites 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 13 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report (time frame: Baseline, 10 weeks (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745146, which also lists 2 linked publications.
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 19 Oct 2018.