Depression and Anxiety Reduction Treatment for Suicide

Study Overview
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Brief Summary
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The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

Detailed Description
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DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of several conditions. In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG. Some participants will also be asked to complete four additional EEG assessments. In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.

Official Title
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Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities

Conditions
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Anxiety, Depression, Suicide

Intervention / Treatment
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* Behavioral: Psychoeducation and Cognitive Bias Modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At or above community sample mean on ASI-3 At or above community sample mean on INQ-R English speakers 18 years of age or older Exclusion Criteria: Significant medical illness Current substance dependence Current or past psychotic-spectrum disorders Uncontrolled bipolar disorder Serious suicidal intent that warranted immediate treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anxiety Risk Reduction<br>The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced. | Behavioral: Psychoeducation and Cognitive Bias Modification<br> <br> |
| Experimental: Mood Risk Reduction<br>The mood risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for perceived burdensomeness and thwarted belongingness. The psychoeducational component will focus on dispelling myths related to burdensomeness and belongingness and describe their role in the development of mood symptoms. | Behavioral: Psychoeducation and Cognitive Bias Modification<br> <br> |
| Experimental: Combined Risk Reduction<br>The combined intervention will involve all of the interventions in the anxiety and mood risk reduction conditions and thus will not be matched for length. | Behavioral: Psychoeducation and Cognitive Bias Modification<br> <br> |
| No Intervention: Repeated Contact Control<br>Participants assigned to the repeated contact group will be assigned a personal study coordinator. The coordinator will contact them at specific intervals during the study. The rationale for these contacts will be provided (e.g., checking in on their status and helping to administer some brief measures). During the three weeks (corresponding to treatment session intervals for those in one of the active treatment conditions), the study coordinator will contact the participant once per week for a brief phone check in where suicide risk will be evaluated. Participants in the control group will also meet with their study coordinator during each of the scheduled follow-up visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interpersonal Needs Questionnaire (INQ) | The INQ is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide. Van Orden et al. report high internal consistency coefficients for the thwarted belongingness (α=.85) and perceived burdensomeness subscales (α=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation. | Month 6 follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Sensitivity Index-3 (ASI-3) | The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties. | Month 6 follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computerized intervention, cognitive bias modification, anxiety, mood, perceived burdensomeness, thwarted belongingness, suicide, post-traumatic stress disorder