Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans

NCT02157779 | Completed Results

• 2 other identifiers: D1146-RRx 001146
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans. The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans. The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy. Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.

Conditions

Anger Problems

Keywords

Veterans; Anger; Cognitive Behavioral Therapy; Treatment

Outcome Measures

Primary Outcomes (2)

• Least Squares Mean Anger Expression Index Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline and Time Effects

  The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items. It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX). Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales. Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.

  Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment

• Least Squares Mean Aggression Scale Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.

  Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment

Secondary Outcomes (5)

• Least Squares Mean Global Social Adjustment Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

• Least Squares Mean Global Work Functioning Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

• Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Baseline, 12 weeks, 3 and 6 months post-treatment

• Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

• Least Squares Mean PTSD Severity Score on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment

Other Outcomes (1)

• Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

  Baseline, Week 12, 3 and 6 months Post-treatment

Study Arms (2)

Cognitive Behavioral Intervention (CBI)

EXPERIMENTAL

12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Behavioral: Cognitive Behavioral Intervention

Supportive Intervention (SI)

ACTIVE COMPARATOR

12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Behavioral: Supportive Intervention

Interventions

Cognitive Behavioral Intervention BEHAVIORAL

Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management

Also known as: CBI

Cognitive Behavioral Intervention (CBI)

Supportive Intervention BEHAVIORAL

Includes individual therapy sessions using supportive and problem-solving strategies.

Supportive Intervention (SI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female current or former member of the military (active duty, National Guard or Reserve) Deployed to Iraq or Afghanistan
• Experience trauma during deployment
• Clinically significant anger
• At least 2 additional symptoms of PTSD hyperarousal
• If on medication, no changes within prior 4 weeks

You may not qualify if:

• Current severe substance use disorder or prior severe substance use disorder not in remission for at least 3 months
• Current psychotic symptoms
• current Mania or Bipolar Disorder
• Current suicidal or homicidal ideation requiring hospitalization
• Any severe cognitive impairment or history of Organic Mental Disorder

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

• Shea MT, Lambert J, Reddy MK, Presseau C, Sevin E, Stout RL. Treatment of trauma related anger in operation enduring freedom, operation Iraqi freedom, and operation New Dawn veterans: Rationale and study protocol. Contemp Clin Trials Commun. 2018 Aug 24;12:26-31. doi: 10.1016/j.conctc.2018.08.011. eCollection 2018 Dec.

  PMID: 30225391 BACKGROUND

Results Point of Contact

• Title: M. Tracie Shea, PhD
• Organization: Providence VA Medical Center

MaryTracie.Shea@va.gov

401-273-7100

Study Officials

• Tracie M. Shea, PhD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: June 6, 2014
• Study Start: January 1, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: November 18, 2021
• Results First Posted: March 16, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: April 1 2021

Locations

US (1)