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

NCT ID: NCT02157779

Last Updated: 2021-11-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Poorly controlled anger is a common problem with often devastating effects in Veterans who have served in a warzone. Adverse consequences include increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Recent evidence indicates that anger and aggression are likely to be problems for a significant proportion of Veterans of Iraq (Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation Enduring Freedom, OEF). A survey of reintegration problems among 754 OEF/OIF combat Veterans receiving VA Medical care showed that anger was the most commonly reported problem, with 57% reporting increased problems in controlling anger. Despite encouraging evidence for efficacy of cognitive behavioral interventions in treating anger in civilian samples, much less is known about the efficacy of such treatments for anger problems in military personnel following exposure to war zone trauma. Promising preliminary findings for individually based cognitive behavioral treatment have been reported, and there is evidence that a group anger management treatment delivered by teleconferencing is as effective as the same treatment delivered in person, but to date there is not a single adequately powered randomized trial designed to test the efficacy of an anger treatment compared to an active control condition in Veterans. Building on findings from the investigators' randomized pilot study, the objective of the current proposal is to conduct a randomized clinical trial with sufficient statistical power to test the effectiveness of a manualized cognitive behavioral intervention (CBI) that has been adapted from an existing treatment (Anger Control Therapy; Novaco, 1994, 2001) for the treatment of anger problems in OEF/OIF/OND Veterans, compared to a manualized supportive therapy intervention (SI) control condition. Ninety OEF/OIF/OND Veterans reporting significant problems with anger will be randomized to receive 12 individual sessions of one of the two study conditions. Outcomes including measures of anger and aggression; interpersonal, social and occupational functioning; and quality of life will be assessed during and at the end of treatment and at 3 and 6 month follow-ups. Exploratory analyses will examine 1) whether a diagnosis of PTSD impacts treatment effectiveness and 2) potential mediators of treatment outcome with CBI.

Conditions

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Anger Problems

Keywords

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Veterans Anger Cognitive Behavioral Therapy Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Behavioral Intervention (CBI)

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

Group Type EXPERIMENTAL

Cognitive Behavioral Intervention

Intervention Type BEHAVIORAL

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

Supportive Intervention (SI)

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

Group Type ACTIVE_COMPARATOR

Supportive Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Behavioral Intervention

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

Intervention Type BEHAVIORAL

Supportive Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBI

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracie M. Shea, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

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Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30225391 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Rx 001146

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D1146-R

Identifier Type: -

Identifier Source: org_study_id