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Anger Self-Management in Traumatic Brain Injury (ASMT)

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ASMT

PRE

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, TBI, head injury, brain injury, Psych-educational treatment, Anger, irritability, anger management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Craig Hospital
Data Cordinating Center
Moss Rehabilitation Research Institue

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anger Self-Management Training (ASMT)

Personal Readjustment and Ed (PRE)

Arm 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

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

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

Full Information

NCT ID

NCT01745146

First Posted

December 6, 2012

Last Updated

October 18, 2018

Sponsor

Albert Einstein Healthcare Network

Collaborators

Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT01745146

Brief Title

Anger Self-Management in Traumatic Brain Injury

Acronym

ASMT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albert Einstein Healthcare Network

Collaborators

Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

traumatic brain injury, TBI, head injury, brain injury, Psych-educational treatment, Anger, irritability, anger management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anger Self-Management Training (ASMT)

Arm Type

Experimental

Arm Description

Arm Title

Personal Readjustment and Ed (PRE)

Arm Type

Active Comparator

Arm 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

Intervention Type

Behavioral

Intervention Name(s)

ASMT

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

PRE

Intervention 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

Primary Outcome Measure Information:

Title

Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report

Description

Time Frame

Baseline, 10 weeks (post-treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tessa Hart, PhD

Organizational Affiliation

Moss Rehabilitation Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Craig Hospital

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80237

Country

United States

Facility Name

Data Cordinating Center

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80237

Country

United States

Facility Name

Moss Rehabilitation Research Institue

City

Elkins Park

State/Province

Pennsylvania

ZIP/Postal Code

19027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

21407088

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.

Results Reference

background

PubMed Identifier

28520666

Citation

Hart 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.

Results Reference

result

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Anger Self-Management in Traumatic Brain Injury

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