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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01918696
Other study ID # 2013.10885
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date September 2016

Study information

Verified date January 2021
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a computerized intervention designed to reduce anger-provoking interpretation biases will reduce suicide risk among individuals with elevated levels of trait anger.


Description:

Problematic anger is often found among returning military veterans, especially those exposed to combat. Anger control problems are associated with difficulties with reintegration. One study of Iraq-Afghanistan combat veterans who used VA medical services (N = 754) found that difficulty controlling anger was the most commonly reported problem experienced since homecoming, occurring among 57% of the sample (Sayer et al., 2010). Problematic anger and hostility have also been linked to risk for suicide (Daniel et al., 2009; Lehnert, Overholser, & Spirito, 1994; Maiuro, O'Sullivan, Michael, & Vitaliano, 1989). From the perspective of the interpersonal-psychological theory of suicide (Joiner, 2005), individuals with problematic anger may be at increased risk for suicide because they engage in impulsive behaviors (e.g., aggression, substance abuse) intended to manage anger. Such behaviors may lead to exposure to painful and provocative events, which increase their acquired capability for engaging in suicidal behavior. Additionally, anger problems often lead to social isolation, which may contribute to greater perceived burdensomeness and a failed sense of belonging, established risk factors for suicide (Van Orden et al., 2010). Anger prone individuals are likely to hold the hostile attribution bias, which reflects the tendency to interpret the ambiguous actions of others as reflecting hostile intent (Wilkowski & Robinson, 2008). Recently, researchers have developed computerized interpretation bias modification (IBM) protocols intended to efficiently reduce interpretive biases. These treatments have shown efficacy in reducing anxiety and depression (Beard & Amir, 2008; Holmes, Lang, & Shah, 2009; Mathews et al., 2007). We have conducted studies using similar procedures that focus on hostile interpretation biases and found our program to successfully reduce anger and hostility. To evaluate the efficacy of the IBM protocol we have developed in reducing anger and suicide risk, we will conduct a three-arm randomized controlled trial over the internet. Military veterans and non-veteran community participants reporting elevated trait anger (N = 120) will be randomized to one of three conditions: 1) IBM; 2) progressive muscle relaxation (PMR); or 3) healthy education videos (control). Each condition will consist of eight 15-minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre- and post-treatment. IBM and PMR conditions will also complete 3-month and 6-month follow-up assessments. To ensure an adequate test of the effects of this intervention on suicide risk, we will oversample for individuals with current suicidal ideation. We hypothesize that: 1) IBM will lead to greater reductions in anger than PMR and control conditions in a sample with problematic anger; 2) IBM will lead to greater reductions in suicidal ideation, perceived burdensomeness, and thwarted belongingness than PMR and control conditions; 3) efficacy of the IBM condition in reducing suicidal ideation will be mediated by reductions in perceived burdensomeness and thwarted belongingness; 4) group differences between IBM and PMR will be maintained at the 3-month and 6-month follow-up assessments.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - elevated levels of trait anger (scoring 19 or higher, or the top 25% of the general population) - must have access to a computer with an internet connection - must also be English speakers Exclusion Criteria: - currently receiving therapy for problematic anger - evidence of serious suicidal intent requiring hospitalization or immediate treatment - evidence of psychotic-spectrum disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Anger Reduction Treatment
Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.
Progressive Muscle Relaxation
Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.
Control Condition
Eight 15-minute sessions of informative videos on healthy living.

Locations

Country Name City State
United States Florida State University, Department of Psychology Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Interpersonal Needs Questionnaire (INQ; Van Orden, Cukrowicz, Witte, & Joiner, 2012 change from baseline at 1-month, 3-month, and 6-months
Primary State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) change from baseline at 1-month, 3-months, and 6-months
Secondary Beck Suicide Scale (BSS; Beck et al., 1979) change from baseline at 1-month, 3-months, and 6-months
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