Anger Self-Management in Traumatic Brain Injury (ASMT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Albert Einstein Healthcare Network
Sponsor:
Collaborators:
University of Washington
Craig Hospital
Information provided by (Responsible Party):
Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01745146
First received: December 6, 2012
Last updated: February 19, 2014
Last verified: January 2014
  Purpose

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 Intervention
Traumatic Brain Injury
Behavioral: ASMT
Behavioral: PRE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial

Resource links provided by NLM:


Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • Change from Baseline on State-Trait Anger Expression Inventory-Revised (STAXI-2) and The Brief Anger-Aggression Questionnaire (BAAQ) [ Time Frame: Baseline, 10 weeks (post-treatment) ] [ Designated as safety issue: No ]
    The STAXI-2 Trait Anger Scale measures how often angry feelings are experienced and the Anger Expression-Out 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


Secondary Outcome Measures:
  • Change from Baseline on the Brief Symptom Inventory-53 (BSI) [ Time Frame: Baseline, 10 weeks (post-treatment), 18 weeks (follow up) ] [ Designated as safety issue: No ]
    This measure consists of 53 emotional distress items that are rated on a 5 point Likert scale and yield a Global Severity Index as well as Symptom Dimensions (Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism).

  • Change from Baseline on Satisfaction With Life Scale (SWLS) Participant Response [ Time Frame: Baseline, 10 weeks (post-treatment), 18 weeks (follow up) ] [ Designated as safety issue: No ]
    This measure is a subjective, 5-item scale of self-rating of global life satisfaction

  • Change from Baseline on Frontal Systems Behavior Scale (FrSB) Participant and the SO Responses [ Time Frame: Baseline, 10 weeks (post-treatment), 18 weeks (follow up) ] [ Designated as safety issue: No ]
    46-item behavior rating scale. Total score and subtest scores in Apathy, Disinhibition, and Executive Dysfunction will be calculated.

  • Change from Baseline on measures of anger symptoms as reported by Significant Others: The State-Trait Anger Expression Inventory-Revised (STAXI-2): Trait Anger and Anger Expression-Out Scales and The Brief Anger-Aggression Questionnaire (BAAQ) [ Time Frame: Time Frame: Baseline, 10 weeks (post-treatment), 18 weeks (follow up) ] [ Designated as safety issue: No ]
    The STAXI-2 Trait Anger Scale measures how often angry feelings are experienced and the Anger Expression-Out Scale addresses the expression of anger toward other persons or objects in the environment.The BAAQ is a 6-item self-report scale that measures frequency of "acting-out" symptoms of anger

  • Change from Post Treatment to Follow up on measures of expressed anger [ Time Frame: 10 weeks (post treament), 18 weeks (follow up) ] [ Designated as safety issue: No ]
    Evaluation of the persistence of treatment effects through analysis of Primary Outcome Measures two months after the conclusion of treatment


Estimated Enrollment: 99
Study Start Date: September 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 problematic anger, both self-reported and reported by significant others (SOs), both 1 week and 2 months after treatment; to assess the time course of treatment response during the treatment phase; to examine effects of the ASMT compared to PRE on a range of outcomes; and to assess the associations between case mix variables, including participant characteristics and injury variables, with treatment response.

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.
  4. To examine the effects of ASMT compared to PRE on anger symptoms as observed by significant others (relatives and close friends) both 1 week and 2 months after treatment.
  5. To examine the impact of ASMT versus PRE on reduction in emotional distress (as measured by the Brief Symptom Inventory) and broader outcomes of emotional/behavioral function, global outcome, and satisfaction with life by viewing between-group differences on self- and other-ratings of frontal/ executive function, measures of life satisfaction and measures of societal participation.
  6. To examine the relationship between ASMT and PRE response rate and participant characteristics, including: gender and racial/ ethnic status; severity and chronicity of TBI; baseline intellectual, memory, and executive function; severity of pre-treatment anger; presence/ severity of PTSD; degree of emotional blunting (alexithymia); involvement/ absence of an SO; and discrepancies between self- and SO report of participant anger. Relationship between treatment site and treatment response will also be examined.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745146

Contacts
Contact: Kelly Bognar 215-663-6411 MacNamaK@einstein.edu

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80237
Principal Investigator: Cynthia Braden, MS, CCC-SLP         
Data Cordinating Center Active, not recruiting
Englewood, Colorado, United States, 80237
United States, Pennsylvania
Moss Rehabilitation Research Institue Recruiting
Elkins Park, Pennsylvania, United States, 19027
Principal Investigator: Tessa Hart, PhD         
United States, Washington
Univerisity of Washington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Sureyya Dikman, PhD         
Sponsors and Collaborators
Albert Einstein Healthcare Network
University of Washington
Craig Hospital
Investigators
Principal Investigator: Tessa Hart, PhD Moss Rehabilitation Research Institute
  More Information

Publications:
Responsible Party: Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01745146     History of Changes
Other Study ID Numbers: R01 ASMT HN4385, 1R01HD061400-01A2
Study First Received: December 6, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014