Building Stronger Allies

Overview

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.

Full Title of Study: “”Building Stronger Allies”: Development and Evaluation of a Web Application Targeting Interpersonal Risk Factors for Suicide in Active Duty Service Members”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • 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.
  • Behavioral: 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.

Arms, Groups and Cohorts

  • Experimental: Building Stronger Allies Condition
    • 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.
  • Placebo Comparator: Health Education Training Condition
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Attentional Control Scale (ACS)
    • Time Frame: Up to year three of the study
    • 20-item measure that assesses the differences in voluntary attentional control (Derryberry & Rothbart, 1988).
  • Anxiety Sensitivity Index – 3 (ASI-3)
    • Time Frame: Up to year three of the study
    • 18-item measure of anxiety sensitivity, or fears of anxiety related sensations (Taylor et al., 2007).
  • Anxiety and Stress Sensitivity (ASS)
    • Time Frame: Up to year three of the study
    • 26-item measure of anxiety, fear, or distress caused by a variety of symptoms or bodily sensations.
  • Alcohol Use Disorders Identification Test (AUDIT)
    • Time Frame: Up to year three of the study
    • 10-item measure of alcohol use and frequency of related problems or consequences (Saunders et al., 1993).
  • Beck Anxiety Inventory (BAI)
    • Time Frame: Up to year three of the study
    • 21-item measure of general anxiety symptomatology (Beck et al.,1988).
  • Beck Depression Inventory (BDI-II)
    • Time Frame: Up to year three of the study
    • 21-item measure that assesses severity of depressive symptomatology (Beck et al., 1988).
  • Beck Hopelessness Scale (BHS)
    • Time Frame: Up to year three of the study
    • current study will use 3 of the 20 items in this measure to assess hopelessness (Beck et al., 1974)
  • Buss-Perry Aggression Questionnaire – Anger Subscale (BPAQ)
    • Time Frame: Up to year three of the study
    • 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)
  • Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)
    • Time Frame: Up to year three of the study
    • 3-item measure about possession of firearms.
  • Client Expectancy Questionnaire (CEQ)
    • Time Frame: Up to year three of the study
    • 8-item questionnaire measuring treatment expectancy and rationale credibility for use in clinical outcome studies (Devilly & Borkovec, 2000).
  • Client Satisfaction Questionnaire (CSQ)
    • Time Frame: Up to year three of the study
    • 8-item measure assessing general satisfaction with services of treatment received by the individual (Attkisson & Zwick, 1982)
  • DARTS Quiz
    • Time Frame: Up to year three of the study
    • 11-item measure assessing general satisfaction with an intervention by asking questions regarding presentation, applicability, and acceptability
  • Disturbing Dream and Nightmare Severity Index (DDNSI)
    • Time Frame: Up to year three of the study
    • up to 16-item measure of nightmare severity and frequency (Krakow et al., 2002)
  • Demographics
    • Time Frame: Up to year three of the study
    • 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).
  • Drug Use Questions (DUQ)
    • Time Frame: Up to year three of the study
    • 2 items created by the MSRC to assess frequency of prescription medication abuse and non-prescription/recreational drug use
  • Dyadic Adjustment Scale (DAS)
    • Time Frame: Up to year three of the study
    • 32-item measure of satisfaction in an intimate relationship (Spanier, 1976).
  • Engagement in Behavioral Health Treatment (EBHT)
    • Time Frame: Up to year three of the study
    • 1 item created by the MSRC to assess number of behavioral health treatment sessions attended in the previous 3 months.
  • Interpersonal Needs Questionnaire (INQ-R)
    • Time Frame: Up to year three of the study
    • 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).
  • *Insomnia Severity Index (ISI)
    • Time Frame: Up to year three of the study
    • 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).
  • Positive and Negative Affect Scale – Negative Affect Subscale (PANAS-NA)
    • Time Frame: Up to year three of the study
    • 10-item measure of levels of negative affect (Watson et al., 1988).
  • PTSD Checklist for DSM-5 (PCL-5)
    • Time Frame: Up to year three of the study
    • 20-item measure of symptoms of PTSD (Blevins et al., 2015).
  • Relationship Closeness Inventory (RCI)
    • Time Frame: Up to year three of the study
    • 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)
  • Sheehan Disability Scale (SDS)
    • Time Frame: Up to year three of the study
    • 4-item measure assessing degree of impairment and disability in several main life areas (Sheehan, 1983)
  • Social Interaction Anxiety Scale (SIAS)
    • Time Frame: Up to year three of the study
    • 20-item measure assessing fears of general social interactions (Mattick & Clarke, 1998).
  • Traumatic Brain Injury – 4 (TBI-4)
    • Time Frame: Up to year three of the study
    • 4-items to screen for potential traumatic brain injuries (Brenner et al., 2012).
  • Use of Behavioral Health Services (UBHS)
    • Time Frame: Up to year three of the study
    • 2 items created by the MSRC to assess the effects of psychotherapy.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Florida State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Norman Schmidt, Principal Investigator – Florida State University
  • Overall Official(s)
    • Lora R Hunter, PhD, Study Chair, Medical Service Corps, United States Army

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.