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

Primary Purpose

Anger, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anger Reduction Treatment
Progressive Muscle Relaxation
Control Condition
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anger focused on measuring suicide, anger, interpretation modification, computerized treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Florida State University, Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Anger Reduction Treatment

Progressive Muscle Relaxation

Control Condition

Arm Description

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.

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."

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.

Outcomes

Primary Outcome Measures

State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)

Secondary Outcome Measures

Beck Suicide Scale (BSS; Beck et al., 1979)

Full Information

First Posted
July 11, 2013
Last Updated
January 26, 2021
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT01918696
Brief Title
Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention
Official Title
Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Suicidal Ideation
Keywords
suicide, anger, interpretation modification, computerized treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anger Reduction Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Progressive Muscle Relaxation
Arm Type
Active Comparator
Arm Description
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."
Arm Title
Control Condition
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Anger Reduction Treatment
Intervention Description
Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
Eight 15-minute sessions of informative videos on healthy living.
Primary Outcome Measure Information:
Title
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)
Time Frame
change from baseline at 1-month, 3-months, and 6-months
Secondary Outcome Measure Information:
Title
Beck Suicide Scale (BSS; Beck et al., 1979)
Time Frame
change from baseline at 1-month, 3-months, and 6-months
Other Pre-specified Outcome Measures:
Title
Interpersonal Needs Questionnaire (INQ; Van Orden, Cukrowicz, Witte, & Joiner, 2012
Time Frame
change from baseline at 1-month, 3-month, and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse R Cougle, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University, Department of Psychology
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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

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