Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention

Sponsor

Florida State University (Other)

Overall Status

Completed

CT.gov ID

NCT01918696

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anger Suicidal Ideation	Behavioral: Anger Reduction Treatment Behavioral: Progressive Muscle Relaxation Behavioral: Control Condition	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anger Reduction Treatment This treatment consists of eight 15-minute sessions. Participants will read scenarios and imagine themselves in these situations: "A driver does not let you over even though you have your blinker on." Next, another will appear to provide a less ambiguous interpretation. One letter will be missing from the key word of this sentence. The sentence will read "They can't s_e you." The participant will fill in the missing letter (to form "see"). Next, this interpretation will be reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is the driver being disrespectful?"). In each session 64 training scenarios will be presented. Participants will never see the same scenario twice over the course of the study.	Behavioral: Anger Reduction Treatment Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.
Active Comparator: Progressive Muscle Relaxation Participants will receive eight 15-minute sessions of PMR. They will listen to a PMR script (Kassinove & Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups. At the end of this procedure, participants will create a plan for when they will use the exercise. They will then type out the sentence: "When I feel [write the feeling you decided on], then I will use this relaxation technique." They will then be told, "Now, go over what you have written and say it quietly to yourself until you can repeat it word for word without having to read what you have written."	Behavioral: Progressive Muscle Relaxation Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.
Placebo Comparator: Control Condition To control for expectancy effects, participants assigned to the control condition will complete eight computerized sessions consisting of psychoeducation on healthy behaviors. These sessions will be matched for time with the active conditions, lasting 15 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep, and will be taken from protocols developed from our ongoing research. This psychoeducation is perceived as credible but has no detectable impact on behavior. After the post-treatment session, participants will be provided with the active ART treatment free of charge if they wish to receive it.	Behavioral: Control Condition Eight 15-minute sessions of informative videos on healthy living.

Arm

Intervention/Treatment

Experimental: Anger Reduction Treatment

This treatment consists of eight 15-minute sessions. Participants will read scenarios and imagine themselves in these situations: "A driver does not let you over even though you have your blinker on." Next, another will appear to provide a less ambiguous interpretation. One letter will be missing from the key word of this sentence. The sentence will read "They can't s_e you." The participant will fill in the missing letter (to form "see"). Next, this interpretation will be reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is the driver being disrespectful?"). In each session 64 training scenarios will be presented. Participants will never see the same scenario twice over the course of the study.

Behavioral: Anger Reduction Treatment

Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.

Active Comparator: Progressive Muscle Relaxation

Participants will receive eight 15-minute sessions of PMR. They will listen to a PMR script (Kassinove & Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups. At the end of this procedure, participants will create a plan for when they will use the exercise. They will then type out the sentence: "When I feel [write the feeling you decided on], then I will use this relaxation technique." They will then be told, "Now, go over what you have written and say it quietly to yourself until you can repeat it word for word without having to read what you have written."

Behavioral: Progressive Muscle Relaxation

Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.

Placebo Comparator: Control Condition

To control for expectancy effects, participants assigned to the control condition will complete eight computerized sessions consisting of psychoeducation on healthy behaviors. These sessions will be matched for time with the active conditions, lasting 15 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep, and will be taken from protocols developed from our ongoing research. This psychoeducation is perceived as credible but has no detectable impact on behavior. After the post-treatment session, participants will be provided with the active ART treatment free of charge if they wish to receive it.

Behavioral: Control Condition

Eight 15-minute sessions of informative videos on healthy living.

Outcome Measures

Primary Outcome Measures

State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) [change from baseline at 1-month, 3-months, and 6-months]

Secondary Outcome Measures

Beck Suicide Scale (BSS; Beck et al., 1979) [change from baseline at 1-month, 3-months, and 6-months]

Other Outcome Measures

Interpersonal Needs Questionnaire (INQ; Van Orden, Cukrowicz, Witte, & Joiner, 2012 [change from baseline at 1-month, 3-month, and 6-months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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