Elkins Park, Pennsylvania 19027

  • Traumatic Brain Injury

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

R01 ASMT HN4385


NCT ID:

NCT01745146


Secondary ID:

1R01HD061400-01A2


Study Acronym:

ASMT


Brief Title:

Anger Self-Management in Traumatic Brain Injury


Official Title:

Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinical Trial


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Albert Einstein Healthcare Network


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

99


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Tessa Hart, PhD
Principal Investigator
Moss Rehabilitation Research Institute
Primary Contact:Kelly Bognar
215-663-6411
MacNamaK@einstein.edu

Study Dates

Start Date:September 2012
Completion Date:December 2016
Completion Type:Anticipated
Primary Completion Date:June 2016
Primary Completion Type:Anticipated
Verification Date:December 2015
Last Changed Date:December 30, 2015
First Received Date:December 6, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from Post Treatment to Follow up on measures of expressed anger
Time Frame:10 weeks (post treament), 18 weeks (follow up)
Safety Issues:False
Description:Evaluation of the persistence of treatment effects through analysis of Primary Outcome Measures two months after the conclusion of treatment
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description: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 fr
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:46-item behavior rating scale. Total score and subtest scores in Apathy, Disinhibition, and Executive Dysfunction will be calculated.
Outcome Type:Secondary Outcome
Measure:Change from Baseline on Satisfaction With Life Scale (SWLS) Participant Response
Time Frame:Baseline, 10 weeks (post-treatment), 18 weeks (follow up)
Safety Issues:False
Description:This measure is a subjective, 5-item scale of self-rating of global life satisfaction
Outcome Type:Secondary Outcome
Measure:Change from Baseline on the Brief Symptom Inventory-53 (BSI)
Time Frame:Baseline, 10 weeks (post-treatment), 18 weeks (follow up)
Safety Issues:False
Description: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, P
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Behavioral
Name:PRE
Description: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
Arm Name:Personal Readjustment and Ed (PRE)
Intervention Type:Behavioral
Name:ASMT
Description: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
Arm Name:Anger Self-Management Training (ASMT)

Study Arms

Study Arm Type:Active Comparator
Arm Name:Personal Readjustment and Ed (PRE)
Description: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
Study Arm Type:Experimental
Arm Name:Anger Self-Management Training (ASMT)
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Albert Einstein Healthcare Network
Agency Class:Other
Agency Type:Collaborator
Agency Name:Craig Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:21407088

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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