Clinical trial NCT03571750: Building Stronger Allies
Official title: "Building Stronger Allies": Development and Evaluation of a Web Application Targeting Interpersonal Risk Factors for Suicide in Active Duty Service Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Risk Reduction
Keywords: Suicide
Prevention
Risk Factor
Intervention
Military
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 510 participants will be randomly assigned to one of two conditions (1) BSA or (2) HET Control.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD)
timeFrame: Up to year three of the study
measure: Suicide Bereavement (ASF)
timeFrame: Up to year three of the study
measure: Beck Suicide Scale (BSS)
timeFrame: Up to year three of the study
measure: Depression Symptom Index - Suicidality Subscale (DSI-SS)
timeFrame: Up to year three of the study
measure: Reasons for Living Inventory (RFL)
timeFrame: Up to year three of the study
measure: Suicidal Behaviors Questionnaire - Revised (SBQ-R)
timeFrame: Up to year three of the study
measure: Suicide Attempt History (SHF)
timeFrame: Up to year three of the study
measure: Suicide Intensity Ratings (SIR)
timeFrame: Up to year three of the study
measure: Suicide Intent Questions (SIS)
timeFrame: Up to year three of the study
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to year three of the study
measure: Implicit Association Task (IAT) for Suicide
timeFrame: Up to year three of the study
measure: Affect Misattribution Procedure (AMP) for Suicide
timeFrame: Up to year three of the study
Secondary outcomes:
measure: Attentional Control Scale (ACS)
timeFrame: Up to year three of the study
measure: Anxiety Sensitivity Index - 3 (ASI-3)
timeFrame: Up to year three of the study
measure: Anxiety and Stress Sensitivity (ASS)
timeFrame: Up to year three of the study
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Up to year three of the study
measure: Beck Anxiety Inventory (BAI)
timeFrame: Up to year three of the study
measure: Beck Depression Inventory (BDI-II)
timeFrame: Up to year three of the study
measure: Beck Hopelessness Scale (BHS)
timeFrame: Up to year three of the study
measure: Buss-Perry Aggression Questionnaire - Anger Subscale (BPAQ)
timeFrame: Up to year three of the study
measure: Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)
timeFrame: Up to year three of the study
measure: Client Expectancy Questionnaire (CEQ)
timeFrame: Up to year three of the study
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Up to year three of the study
measure: DARTS Quiz
timeFrame: Up to year three of the study
measure: Disturbing Dream and Nightmare Severity Index (DDNSI)
timeFrame: Up to year three of the study
measure: Demographics
timeFrame: Up to year three of the study
measure: Drug Use Questions (DUQ)
timeFrame: Up to year three of the study
measure: Dyadic Adjustment Scale (DAS)
timeFrame: Up to year three of the study
measure: Engagement in Behavioral Health Treatment (EBHT)
timeFrame: Up to year three of the study
measure: Interpersonal Needs Questionnaire (INQ-R)
timeFrame: Up to year three of the study
measure: *Insomnia Severity Index (ISI)
timeFrame: Up to year three of the study
measure: Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)
timeFrame: Up to year three of the study
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Up to year three of the study
measure: Relationship Closeness Inventory (RCI)
timeFrame: Up to year three of the study
measure: Sheehan Disability Scale (SDS)
timeFrame: Up to year three of the study
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: Up to year three of the study
measure: Traumatic Brain Injury - 4 (TBI-4)
timeFrame: Up to year three of the study
measure: Use of Behavioral Health Services (UBHS)
timeFrame: Up to year three of the study
Other outcomes:
Locations:
city: Fort Campbell North
country: United States
facility: 101st Airborne Division (Air Assault) Combat Aviation Brigade
state: Kentucky
Study officials:
affiliation: Medical Service Corps, United States Army
name: Lora R Hunter, PhD
role: STUDY_CHAIR
References: