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Completed

NCT Number: NCT03571750

Building Stronger Allies

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

101st Airborne Division (Air Assault) Combat Aviation Brigade

Fort Campbell North, Kentucky, 42223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BSA

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.

Other names: HET

Primary outcomes

  1. 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).

  2. 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.

  3. 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)

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. Beck Anxiety Inventory (BAI)

    Time frame: Up to year three of the study

    21-item measure of general anxiety symptomatology (Beck et al.,1988).

  6. 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).

  7. 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)

  8. 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)

  9. 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.

  10. 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).

  11. 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)

  12. 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

  13. 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)

  14. 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).

  15. 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

  16. Dyadic Adjustment Scale (DAS)

    Time frame: Up to year three of the study

    32-item measure of satisfaction in an intimate relationship (Spanier, 1976).

  17. 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.

  18. 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).

  19. *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).

  20. 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).

  21. 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).

  22. 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)

  23. 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)

  24. 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).

  25. 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).

  26. 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Acronym: BSA

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 28, 2018
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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