Depression and Anxiety Reduction Treatment for Suicide

NCT01941862 | Completed

• 1 other identifier: W81XWH-10-2-0181
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression; Suicide

Keywords

computerized intervention; cognitive bias modification; anxiety; mood; perceived burdensomeness; thwarted belongingness; suicide; post-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety Sensitivity Index-3 (ASI-3)

  Month 6 follow-up

Other Outcomes (1)

• Beck Suicide Scale (BSS)

  Month 6 follow-up

Study Arms (4)

Anxiety Risk Reduction

EXPERIMENTAL

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

Mood Risk Reduction

EXPERIMENTAL

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

Combined Risk Reduction

EXPERIMENTAL

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

Repeated Contact Control

NO INTERVENTION

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.

Interventions

Psychoeducation and Cognitive Bias Modification BEHAVIORAL

Anxiety Risk Reduction; Combined Risk Reduction; Mood Risk Reduction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At or above community sample mean on ASI-3
• At or above community sample mean on INQ-R
• English speakers
• years of age or older

You may not qualify if:

• Significant medical illness
• Current substance dependence
• Current or past psychotic-spectrum disorders
• Uncontrolled bipolar disorder
• Serious suicidal intent that warranted immediate treatment

Sponsors & Collaborators

• Florida State University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

Related Publications (5)

• Santopetro NJ, Thompson B, Albanese B, Brush CJ, Schmidt NB. Depression Remission Over Six Months Characterized by Elevated Target-Locked P300 ERP Component: Prospective Evidence Employing an Affective Visual Oddball Task. Psychophysiology. 2025 May;62(5):e70067. doi: 10.1111/psyp.70067.

  PMID: 40345151 DERIVED

• Capron DW, Allan NP, Schmidt NB. The Depression Sensitivity Index: Initial Development and Tests of Convergent and Construct Validity. J Affect Disord. 2021 May 15;287:417-426. doi: 10.1016/j.jad.2021.03.051. Epub 2021 Mar 31.

  PMID: 33839487 DERIVED

• Short NA, Stentz L, Raines AM, Boffa JW, Schmidt NB. Intervening on Thwarted Belongingness and Perceived Burdensomeness to Reduce Suicidality Among Veterans: Subanalyses From a Randomized Controlled Trial. Behav Ther. 2019 Sep;50(5):886-897. doi: 10.1016/j.beth.2019.01.004. Epub 2019 Jan 24.

  PMID: 31422845 DERIVED

• Macatee RJ, Albanese BJ, Clancy K, Allan NP, Bernat EM, Cougle JR, Schmidt NB. Distress intolerance modulation of neurophysiological markers of cognitive control during a complex go/no-go task. J Abnorm Psychol. 2018 Jan;127(1):12-29. doi: 10.1037/abn0000323.

  PMID: 29369665 DERIVED

• Short NA, Boffa JW, Norr AM, Albanese BJ, Allan NP, Schmidt NB. Randomized Clinical Trial Investigating the Effects of an Anxiety Sensitivity Intervention on Posttraumatic Stress Symptoms: A Replication and Extension. J Trauma Stress. 2017 Jun;30(3):296-303. doi: 10.1002/jts.22194. Epub 2017 Jun 6.

  PMID: 28585746 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Suicide; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Norman B Schmidt, Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: September 13, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

US (1)