Building Stronger Allies

Suicide Clinical Trial

— BSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571750
• Other study ID #: W81XWH-16-2-003
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Risk Reduction
• Suicide

Intervention

Behavioral:
• Building Stronger Allies
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.
• Health Education Training
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.

Locations

Country	Name	City	State
United States	101st Airborne Division (Air Assault) Combat Aviation Brigade	Fort Campbell North	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Attentional Control Scale (ACS)	20-item measure that assesses the differences in voluntary attentional control (Derryberry & Rothbart, 1988).	Up to year three of the study
Secondary	Anxiety Sensitivity Index - 3 (ASI-3)	18-item measure of anxiety sensitivity, or fears of anxiety related sensations (Taylor et al., 2007).	Up to year three of the study
Secondary	Anxiety and Stress Sensitivity (ASS)	26-item measure of anxiety, fear, or distress caused by a variety of symptoms or bodily sensations.	Up to year three of the study
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	10-item measure of alcohol use and frequency of related problems or consequences (Saunders et al., 1993).	Up to year three of the study
Secondary	Beck Anxiety Inventory (BAI)	21-item measure of general anxiety symptomatology (Beck et al.,1988).	Up to year three of the study
Secondary	Beck Depression Inventory (BDI-II)	21-item measure that assesses severity of depressive symptomatology (Beck et al., 1988).	Up to year three of the study
Secondary	Beck Hopelessness Scale (BHS)	current study will use 3 of the 20 items in this measure to assess hopelessness (Beck et al., 1974)	Up to year three of the study
Secondary	Buss-Perry Aggression Questionnaire - Anger Subscale (BPAQ)	current study will use the 7-item anger subscale of this 29-item measure to assess participant's experience and expression of anger (Buss & Perry, 1992)	Up to year three of the study
Secondary	Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)	3-item measure about possession of firearms.	Up to year three of the study
Secondary	Client Expectancy Questionnaire (CEQ)	8-item questionnaire measuring treatment expectancy and rationale credibility for use in clinical outcome studies (Devilly & Borkovec, 2000).	Up to year three of the study
Secondary	Client Satisfaction Questionnaire (CSQ)	8-item measure assessing general satisfaction with services of treatment received by the individual (Attkisson & Zwick, 1982)	Up to year three of the study
Secondary	DARTS Quiz	11-item measure assessing general satisfaction with an intervention by asking questions regarding presentation, applicability, and acceptability	Up to year three of the study
Secondary	Disturbing Dream and Nightmare Severity Index (DDNSI)	up to 16-item measure of nightmare severity and frequency (Krakow et al., 2002)	Up to year three of the study
Secondary	Demographics	scale was created to collect data on the participants' gender, ethnicity, educational/occupational level, and current medications. It includes additional questions about military service career variables (e.g., duration of active duty, number of deployments).	Up to year three of the study
Secondary	Drug Use Questions (DUQ)	2 items created by the MSRC to assess frequency of prescription medication abuse and non-prescription/recreational drug use	Up to year three of the study
Secondary	Dyadic Adjustment Scale (DAS)	32-item measure of satisfaction in an intimate relationship (Spanier, 1976).	Up to year three of the study
Secondary	Engagement in Behavioral Health Treatment (EBHT)	1 item created by the MSRC to assess number of behavioral health treatment sessions attended in the previous 3 months.	Up to year three of the study
Secondary	Interpersonal Needs Questionnaire (INQ-R)	15-item measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide (Van Orden et al., 2012).	Up to year three of the study
Secondary	*Insomnia Severity Index (ISI)	7-item measure of the symptoms of and consequences of insomnia and the degree of concerns/distress caused by those difficulties (Bastien et al., 2001).	Up to year three of the study
Secondary	Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)	10-item measure of levels of negative affect (Watson et al., 1988).	Up to year three of the study
Secondary	PTSD Checklist for DSM-5 (PCL-5)	20-item measure of symptoms of PTSD (Blevins et al., 2015).	Up to year three of the study
Secondary	Relationship Closeness Inventory (RCI)	measure of interpersonal closeness in a relationship (Snyder & Omoto, 1989). It consists of three subscales assessing amount of time spent together (Frequency), number of different activities done together (Diversity), and the influence another has on one's behaviors, activities, and decisions (Strength)	Up to year three of the study
Secondary	Sheehan Disability Scale (SDS)	4-item measure assessing degree of impairment and disability in several main life areas (Sheehan, 1983)	Up to year three of the study
Secondary	Social Interaction Anxiety Scale (SIAS)	20-item measure assessing fears of general social interactions (Mattick & Clarke, 1998).	Up to year three of the study
Secondary	Traumatic Brain Injury - 4 (TBI-4)	4-items to screen for potential traumatic brain injuries (Brenner et al., 2012).	Up to year three of the study
Secondary	Use of Behavioral Health Services (UBHS)	2 items created by the MSRC to assess the effects of psychotherapy.	Up to year three of the study