AngerNCT01918696
Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention
A study testing Anger Reduction Treatment and Progressive Muscle Relaxation in people with Anger and Suicidal Ideation, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anger, Suicidal Ideation
- What is being tested?
- Anger Reduction Treatment and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently receiving therapy for problematic anger
- evidence of serious suicidal intent requiring hospitalization or immediate treatment
- evidence of psychotic-spectrum disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University, Department of Psychology
Tallahassee, Florida, 32306
About this study
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.
Read the 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.
- Conditions
- Anger, Suicidal Ideation
- Being tested
- Anger Reduction Treatment, Progressive Muscle Relaxation, Control Condition
- Keywords
- suicide, anger, interpretation modification, computerized treatment
- Medical subject headings
- Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anger Reduction TreatmentBehavioural
Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.
Progressive Muscle RelaxationBehavioural
Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.
Control ConditionBehavioural
Eight 15-minute sessions of informative videos on healthy living.
| Study group | Role | What they receive |
|---|---|---|
| Anger Reduction Treatment | Experimental | 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. Receives: Behavioral: Anger Reduction Treatment |
| Progressive Muscle Relaxation | Active comparator | 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." Receives: Behavioral: Progressive Muscle Relaxation |
| Control Condition | Placebo comparator | 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. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)
Measured: change from baseline at 1-month, 3-months, and 6-months
Secondary outcomes (1)
Beck Suicide Scale (BSS; Beck et al., 1979)
Measured: change from baseline at 1-month, 3-months, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
- Investigators
- Jesse R Cougle, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918696
- Sponsor's protocol ID
- 2013.10885
- Status last verified
- Jan 2021
- First submitted
- 11 Jul 2013
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention
- ClinicalTrials.gov ID
- NCT01918696
- Acronym / sponsor ID
- 2013.10885
- Conditions
- Anger, Suicidal Ideation
- Keywords
- suicide, anger, interpretation modification, computerized treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anger Reduction Treatment | Experimental | Behavioral: Anger Reduction TreatmentThis 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. |
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants 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." |
| Control Condition | Placebo comparator | Behavioral: Control ConditionTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- currently receiving therapy for problematic anger
- evidence of serious suicidal intent requiring hospitalization or immediate treatment
- evidence of psychotic-spectrum disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anger Reduction TreatmentEight 15-minute sessions of interpretation modification to reduce angry interpretation biases. | Behavioural | Anger Reduction Treatment |
| Progressive Muscle RelaxationEight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry. | Behavioural | Progressive Muscle Relaxation |
| Control ConditionEight 15-minute sessions of informative videos on healthy living. | Behavioural | Control Condition |
Primary outcome
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)
Time frame: change from baseline at 1-month, 3-months, and 6-months
1 secondary outcome
Beck Suicide Scale (BSS; Beck et al., 1979)
Time frame: change from baseline at 1-month, 3-months, and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse R Cougle, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anger Reduction Treatment and Progressive Muscle Relaxation in people with Anger and Suicidal Ideation, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) (time frame: change from baseline at 1-month, 3-months, and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.