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.