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Clinical Trials/NCT03571750
NCT03571750CompletedNot Applicable

"Building Stronger Allies": Development and Evaluation of a Web Application Targeting Interpersonal Risk Factors for Suicide in Active Duty Service Members

Florida State University1 site in 1 country233 target enrollmentStarted: May 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
233
Locations
1
Primary Endpoint
Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD)

Study Overview

Brief Summary

BSA is a novel, computerized intervention specifically designed for active military personnel with the intent to reduce two risk factors known to be associated with suicide outcomes.

Detailed Description

The investigators have focused on the identification of malleable risk factors for preventative intervention in a number of types of psychopathology including suicidality. In the case of Perceived Burdensomeness (PB) and Thwarted Belongingness (TB), theory suggests that they may be malleable, though this has received little empirical attention. Taken together, the Interpersonal Theory of Suicide and related empirical literature suggest that targeting PB/TB should offer a novel and important avenue to reduce suicidality. This inspired the investigators' efforts to create and evaluate an intervention - called Building Stronger Allies (BSA) - designed to reduce these factors.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Must show at least some suicide risk based on scoring > 0 on the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • •Must also own a Smartphone.

Exclusion Criteria

  • •No evidence of such serious suicidal risk that would indicate a need for immediate hospitalization or emergency intervention.
  • •No planned moves/deployments for the next 3 months.

Arms & Interventions

Building Stronger Allies Condition

Experimental

BSA was developed to model the educational and behavioral techniques commonly employed in the treatment of individuals with mood psychopathology. The psychoeducation portion uses Cognitive Behavioral Therapy principles to correct problematic ideas and behaviors related to PB/TB. More specifically, the program was designed to correct "myths" regarding PB/TB. The program emphasizes the idea that social interaction is a critical need, just like other basic needs such as the need for food and water. Participants are taught that negative beliefs about being isolated and being a burden are usually inaccurate. Following this, behavioral activation techniques are introduced as a way to decrease isolation and feelings of burdensomeness.

Intervention: Building Stronger Allies (Behavioral)

Health Education Training Condition

Placebo Comparator

In the HET condition, participants will spend approximately the same amount of time with a program that will present information regarding the importance and benefits of a maintaining a healthy lifestyle and then will provide guidelines to achieve a healthy lifestyle. HET is shown to engage participants with beneficial information while being inert with respect to the risk mechanisms of interest (i.e., PB/TB). The program covers a number of health related topics including: diet, alcohol use, water consumption, exercise, and sleep. The program reviews with the Participants how to monitor their own daily health habits, which will be reinforced by the Smartphone application.

Intervention: Health Education Training (Behavioral)

Outcomes

Primary Outcomes

Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD)

Time Frame: Up to year three of the study

7-item measure that assesses the degree to which individuals feel fearless or unafraid about death (Ribeiro et al., 2014).

Suicide Bereavement (ASF)

Time Frame: Up to year three of the study

1 item created by the MSRC to obtain information regarding the experience of knowing someone who died by suicide.

Beck Suicide Scale (BSS)

Time Frame: Up to year three of the study

21-item measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts (Beck et al.,1979)

Depression Symptom Index - Suicidality Subscale (DSI-SS)

Time Frame: Up to year three of the study

4-item measure to assess the frequency and intensity of suicidal ideation and impulses (Joiner et al., 2002).

Reasons for Living Inventory (RFL)

Time Frame: Up to year three of the study

current study will use 18 items (3 from each of the 6 subscales) from the 48-item measure of how important, to each respective participant, are common reasons individuals give for not committing suicide (Linehan et al., 1983).

Suicidal Behaviors Questionnaire - Revised (SBQ-R)

Time Frame: Up to year three of the study

4-item measure assessing four dimensions of suicide (lifetime ideation and attempts, 12 month frequency of ideation, threat of suicidal behavior, and likelihood of suicidal behavior; Osman et al., 2001).

Suicide Attempt History (SHF)

Time Frame: Up to year three of the study

6 items created by the MSRC to assess history of suicide attempts, most lethal attempt, and non-suicidal self-injury.

Suicide Intensity Ratings (SIR)

Time Frame: Up to year three of the study

3 items to assess current intent and desire to die by suicide, as well as current intensity of suicidal ideation.

Suicide Intent Questions (SIS)

Time Frame: Up to year three of the study

4 items picked by the MSRC to assess thoughts and feelings during most recent engagement in self-injury with intent to die.

Columbia-Suicide Severity Rating Scale (C-SSRS)

Time Frame: Up to year three of the study

a structured clinical interview that measures the presence, frequency, and characteristics of various types of suicidal thoughts and behaviors.

Implicit Association Task (IAT) for Suicide

Time Frame: Up to year three of the study

We will use Nock's IAT for suicide as a behavioral index of suicide risk. This procedure has demonstrated that implicit associations for death /self are stronger among those with a suicide attempt history relative to psychiatric controls without a history of suicide attempts.

Affect Misattribution Procedure (AMP) for Suicide

Time Frame: Up to year three of the study

We will use a modified version of the AMP task using suicide-relevant stimuli as an additional implicit measure of suicide risk. A variant of this task has been found to predict suicidal behavior

Secondary Outcomes

  • Beck Depression Inventory (BDI-II)(Up to year three of the study)
  • Beck Hopelessness Scale (BHS)(Up to year three of the study)
  • Disturbing Dream and Nightmare Severity Index (DDNSI)(Up to year three of the study)
  • Attentional Control Scale (ACS)(Up to year three of the study)
  • Anxiety Sensitivity Index - 3 (ASI-3)(Up to year three of the study)
  • Anxiety and Stress Sensitivity (ASS)(Up to year three of the study)
  • Alcohol Use Disorders Identification Test (AUDIT)(Up to year three of the study)
  • Beck Anxiety Inventory (BAI)(Up to year three of the study)
  • Buss-Perry Aggression Questionnaire - Anger Subscale (BPAQ)(Up to year three of the study)
  • Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)(Up to year three of the study)
  • Client Expectancy Questionnaire (CEQ)(Up to year three of the study)
  • Client Satisfaction Questionnaire (CSQ)(Up to year three of the study)
  • DARTS Quiz(Up to year three of the study)
  • Demographics(Up to year three of the study)
  • Drug Use Questions (DUQ)(Up to year three of the study)
  • Engagement in Behavioral Health Treatment (EBHT)(Up to year three of the study)
  • Interpersonal Needs Questionnaire (INQ-R)(Up to year three of the study)
  • *Insomnia Severity Index (ISI)(Up to year three of the study)
  • Dyadic Adjustment Scale (DAS)(Up to year three of the study)
  • Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)(Up to year three of the study)
  • PTSD Checklist for DSM-5 (PCL-5)(Up to year three of the study)
  • Relationship Closeness Inventory (RCI)(Up to year three of the study)
  • Sheehan Disability Scale (SDS)(Up to year three of the study)
  • Social Interaction Anxiety Scale (SIAS)(Up to year three of the study)
  • Traumatic Brain Injury - 4 (TBI-4)(Up to year three of the study)
  • Use of Behavioral Health Services (UBHS)(Up to year three of the study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Norman Schmidt

Principal Investigator

Florida State University

Study Sites (1)

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