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Anger Self-Management in Traumatic Brain Injury (ASMT)

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ClinicalTrials.gov Identifier: NCT01745146
Recruitment Status : Completed
First Posted : December 10, 2012
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
Craig Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Tessa Hart, Albert Einstein Healthcare Network

Brief 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 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: ASMT Behavioral: PRE Not Applicable

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

  1. 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).
  2. 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).
  3. To examine the persistence of treatment effects 2 months after the end of the treatment phase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial
Study Start Date : September 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anger Self-Management Training (ASMT)
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
Behavioral: ASMT
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

Active Comparator: Personal Readjustment and Ed (PRE)
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
Behavioral: PRE
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




Primary Outcome Measures :
  1. 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").



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
    • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745146


Locations
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United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80237
Data Cordinating Center
Englewood, Colorado, United States, 80237
United States, Pennsylvania
Moss Rehabilitation Research Institue
Elkins Park, Pennsylvania, United States, 19027
Sponsors and Collaborators
Albert Einstein Healthcare Network
Craig Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Tessa Hart, PhD Moss Rehabilitation Research Institute

Publications of Results:
Other Publications:
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Responsible Party: Tessa Hart, Institute Scientist, MRRI, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01745146     History of Changes
Other Study ID Numbers: R01 ASMT HN4385
1R01HD061400-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2012    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tessa Hart, Albert Einstein Healthcare Network:
traumatic brain injury
TBI
head injury
brain injury
Psych-educational treatment
Anger
irritability
anger management

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System