Building Stronger Allies

NCT03571750 | Completed

• 1 other identifier: W81XWH-16-2-003
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Risk Reduction

Keywords

Suicide; Prevention; Risk Factor; Intervention; Military

Outcome Measures

Primary Outcomes (12)

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

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

  Up to year three of the study

• Suicide Bereavement (ASF)

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

  Up to year three of the study

• Beck Suicide Scale (BSS)

  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)

  Up to year three of the study

• Depression Symptom Index - Suicidality Subscale (DSI-SS)

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

  Up to year three of the study

• Reasons for Living Inventory (RFL)

  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).

  Up to year three of the study

• Suicidal Behaviors Questionnaire - Revised (SBQ-R)

  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).

  Up to year three of the study

• Suicide Attempt History (SHF)

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

  Up to year three of the study

• Suicide Intensity Ratings (SIR)

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

  Up to year three of the study

• Suicide Intent Questions (SIS)

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

  Up to year three of the study

• Columbia-Suicide Severity Rating Scale (C-SSRS)

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

  Up to year three of the study

• Implicit Association Task (IAT) for Suicide

  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.

  Up to year three of the study

• Affect Misattribution Procedure (AMP) for Suicide

  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

  Up to year three of the study

Secondary Outcomes (26)

• 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

Study Arms (2)

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.

Behavioral: Building Stronger Allies

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.

Behavioral: Health Education Training

Interventions

Building Stronger Allies BEHAVIORAL

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.

Also known as: BSA

Building Stronger Allies Condition

Health Education Training BEHAVIORAL

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.

Also known as: HET

Health Education Training Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

101st Airborne Division (Air Assault) Combat Aviation Brigade

Fort Campbell North, Kentucky, 42223, United States

Location

MeSH Terms

Conditions

Suicide; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Lora R Hunter, PhD

  Medical Service Corps, United States Army

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Approximately 510 participants will be randomly assigned to one of two conditions (1) BSA or (2) HET Control.

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 28, 2018
• Study Start: May 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)