Depression and Anxiety Reduction Treatment for Suicide (DARTS)

Florida State University

Status: Completed

Conditions: Depression; Anxiety; Suicide

Treatments: Behavioral: Psychoeducation and Cognitive Bias Modification

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01941862

W81XWH-10-2-0181

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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300 participants in 4 patient groups

Anxiety Risk Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Psychoeducation and Cognitive Bias Modification

Mood Risk Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Psychoeducation and Cognitive Bias Modification

Combined Risk Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Psychoeducation and Cognitive Bias Modification

Repeated Contact Control

No Intervention group

Description:

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.