Back to resultsBuilding Stronger Allies (BSA)
Primary Purpose
Suicide, Risk Reduction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Building Stronger Allies
Health Education Training
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Suicide, Prevention, Risk Factor, Intervention, Military
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.
Sites / Locations
- 101st Airborne Division (Air Assault) Combat Aviation Brigade
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Building Stronger Allies Condition
Health Education Training Condition
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Suicide Bereavement (ASF)
1 item created by the MSRC to obtain information regarding the experience of knowing someone who died by suicide.
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)
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).
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).
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).
Suicide Attempt History (SHF)
6 items created by the MSRC to assess history of suicide attempts, most lethal attempt, and non-suicidal self-injury.
Suicide Intensity Ratings (SIR)
3 items to assess current intent and desire to die by suicide, as well as current intensity of suicidal ideation.
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.
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.
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.
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
Secondary Outcome Measures
Attentional Control Scale (ACS)
20-item measure that assesses the differences in voluntary attentional control (Derryberry & Rothbart, 1988).
Anxiety Sensitivity Index - 3 (ASI-3)
18-item measure of anxiety sensitivity, or fears of anxiety related sensations (Taylor et al., 2007).
Anxiety and Stress Sensitivity (ASS)
26-item measure of anxiety, fear, or distress caused by a variety of symptoms or bodily sensations.
Alcohol Use Disorders Identification Test (AUDIT)
10-item measure of alcohol use and frequency of related problems or consequences (Saunders et al., 1993).
Beck Anxiety Inventory (BAI)
21-item measure of general anxiety symptomatology (Beck et al.,1988).
Beck Depression Inventory (BDI-II)
21-item measure that assesses severity of depressive symptomatology (Beck et al., 1988).
Beck Hopelessness Scale (BHS)
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)
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)
3-item measure about possession of firearms.
Client Expectancy Questionnaire (CEQ)
8-item questionnaire measuring treatment expectancy and rationale credibility for use in clinical outcome studies (Devilly & Borkovec, 2000).
Client Satisfaction Questionnaire (CSQ)
8-item measure assessing general satisfaction with services of treatment received by the individual (Attkisson & Zwick, 1982)
DARTS Quiz
11-item measure assessing general satisfaction with an intervention by asking questions regarding presentation, applicability, and acceptability
Disturbing Dream and Nightmare Severity Index (DDNSI)
up to 16-item measure of nightmare severity and frequency (Krakow et al., 2002)
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).
Drug Use Questions (DUQ)
2 items created by the MSRC to assess frequency of prescription medication abuse and non-prescription/recreational drug use
Dyadic Adjustment Scale (DAS)
32-item measure of satisfaction in an intimate relationship (Spanier, 1976).
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.
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).
*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).
Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)
10-item measure of levels of negative affect (Watson et al., 1988).
PTSD Checklist for DSM-5 (PCL-5)
20-item measure of symptoms of PTSD (Blevins et al., 2015).
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)
Sheehan Disability Scale (SDS)
4-item measure assessing degree of impairment and disability in several main life areas (Sheehan, 1983)
Social Interaction Anxiety Scale (SIAS)
20-item measure assessing fears of general social interactions (Mattick & Clarke, 1998).
Traumatic Brain Injury - 4 (TBI-4)
4-items to screen for potential traumatic brain injuries (Brenner et al., 2012).
Use of Behavioral Health Services (UBHS)
2 items created by the MSRC to assess the effects of psychotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03571750
Brief Title
Building Stronger Allies
Acronym
BSA
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Risk Reduction
Keywords
Suicide, Prevention, Risk Factor, Intervention, Military
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Approximately 510 participants will be randomly assigned to one of two conditions (1) BSA or (2) HET Control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Building Stronger Allies Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Training Condition
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Building Stronger Allies
Other Intervention Name(s)
BSA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Training
Other Intervention Name(s)
HET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD)
Description
7-item measure that assesses the degree to which individuals feel fearless or unafraid about death (Ribeiro et al., 2014).
Time Frame
Up to year three of the study
Title
Suicide Bereavement (ASF)
Description
1 item created by the MSRC to obtain information regarding the experience of knowing someone who died by suicide.
Time Frame
Up to year three of the study
Title
Beck Suicide Scale (BSS)
Description
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)
Time Frame
Up to year three of the study
Title
Depression Symptom Index - Suicidality Subscale (DSI-SS)
Description
4-item measure to assess the frequency and intensity of suicidal ideation and impulses (Joiner et al., 2002).
Time Frame
Up to year three of the study
Title
Reasons for Living Inventory (RFL)
Description
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).
Time Frame
Up to year three of the study
Title
Suicidal Behaviors Questionnaire - Revised (SBQ-R)
Description
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).
Time Frame
Up to year three of the study
Title
Suicide Attempt History (SHF)
Description
6 items created by the MSRC to assess history of suicide attempts, most lethal attempt, and non-suicidal self-injury.
Time Frame
Up to year three of the study
Title
Suicide Intensity Ratings (SIR)
Description
3 items to assess current intent and desire to die by suicide, as well as current intensity of suicidal ideation.
Time Frame
Up to year three of the study
Title
Suicide Intent Questions (SIS)
Description
4 items picked by the MSRC to assess thoughts and feelings during most recent engagement in self-injury with intent to die.
Time Frame
Up to year three of the study
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
a structured clinical interview that measures the presence, frequency, and characteristics of various types of suicidal thoughts and behaviors.
Time Frame
Up to year three of the study
Title
Implicit Association Task (IAT) for Suicide
Description
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.
Time Frame
Up to year three of the study
Title
Affect Misattribution Procedure (AMP) for Suicide
Description
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
Time Frame
Up to year three of the study
Secondary Outcome Measure Information:
Title
Attentional Control Scale (ACS)
Description
20-item measure that assesses the differences in voluntary attentional control (Derryberry & Rothbart, 1988).
Time Frame
Up to year three of the study
Title
Anxiety Sensitivity Index - 3 (ASI-3)
Description
18-item measure of anxiety sensitivity, or fears of anxiety related sensations (Taylor et al., 2007).
Time Frame
Up to year three of the study
Title
Anxiety and Stress Sensitivity (ASS)
Description
26-item measure of anxiety, fear, or distress caused by a variety of symptoms or bodily sensations.
Time Frame
Up to year three of the study
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
10-item measure of alcohol use and frequency of related problems or consequences (Saunders et al., 1993).
Time Frame
Up to year three of the study
Title
Beck Anxiety Inventory (BAI)
Description
21-item measure of general anxiety symptomatology (Beck et al.,1988).
Time Frame
Up to year three of the study
Title
Beck Depression Inventory (BDI-II)
Description
21-item measure that assesses severity of depressive symptomatology (Beck et al., 1988).
Time Frame
Up to year three of the study
Title
Beck Hopelessness Scale (BHS)
Description
current study will use 3 of the 20 items in this measure to assess hopelessness (Beck et al., 1974)
Time Frame
Up to year three of the study
Title
Buss-Perry Aggression Questionnaire - Anger Subscale (BPAQ)
Description
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)
Time Frame
Up to year three of the study
Title
Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)
Description
3-item measure about possession of firearms.
Time Frame
Up to year three of the study
Title
Client Expectancy Questionnaire (CEQ)
Description
8-item questionnaire measuring treatment expectancy and rationale credibility for use in clinical outcome studies (Devilly & Borkovec, 2000).
Time Frame
Up to year three of the study
Title
Client Satisfaction Questionnaire (CSQ)
Description
8-item measure assessing general satisfaction with services of treatment received by the individual (Attkisson & Zwick, 1982)
Time Frame
Up to year three of the study
Title
DARTS Quiz
Description
11-item measure assessing general satisfaction with an intervention by asking questions regarding presentation, applicability, and acceptability
Time Frame
Up to year three of the study
Title
Disturbing Dream and Nightmare Severity Index (DDNSI)
Description
up to 16-item measure of nightmare severity and frequency (Krakow et al., 2002)
Time Frame
Up to year three of the study
Title
Demographics
Description
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).
Time Frame
Up to year three of the study
Title
Drug Use Questions (DUQ)
Description
2 items created by the MSRC to assess frequency of prescription medication abuse and non-prescription/recreational drug use
Time Frame
Up to year three of the study
Title
Dyadic Adjustment Scale (DAS)
Description
32-item measure of satisfaction in an intimate relationship (Spanier, 1976).
Time Frame
Up to year three of the study
Title
Engagement in Behavioral Health Treatment (EBHT)
Description
1 item created by the MSRC to assess number of behavioral health treatment sessions attended in the previous 3 months.
Time Frame
Up to year three of the study
Title
Interpersonal Needs Questionnaire (INQ-R)
Description
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).
Time Frame
Up to year three of the study
Title
*Insomnia Severity Index (ISI)
Description
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).
Time Frame
Up to year three of the study
Title
Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)
Description
10-item measure of levels of negative affect (Watson et al., 1988).
Time Frame
Up to year three of the study
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
20-item measure of symptoms of PTSD (Blevins et al., 2015).
Time Frame
Up to year three of the study
Title
Relationship Closeness Inventory (RCI)
Description
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)
Time Frame
Up to year three of the study
Title
Sheehan Disability Scale (SDS)
Description
4-item measure assessing degree of impairment and disability in several main life areas (Sheehan, 1983)
Time Frame
Up to year three of the study
Title
Social Interaction Anxiety Scale (SIAS)
Description
20-item measure assessing fears of general social interactions (Mattick & Clarke, 1998).
Time Frame
Up to year three of the study
Title
Traumatic Brain Injury - 4 (TBI-4)
Description
4-items to screen for potential traumatic brain injuries (Brenner et al., 2012).
Time Frame
Up to year three of the study
Title
Use of Behavioral Health Services (UBHS)
Description
2 items created by the MSRC to assess the effects of psychotherapy.
Time Frame
Up to year three of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora R Hunter, PhD
Organizational Affiliation
Medical Service Corps, United States Army
Official's Role
Study Chair
Facility Information:
Facility Name
101st Airborne Division (Air Assault) Combat Aviation Brigade
City
Fort Campbell North
State/Province
Kentucky
ZIP/Postal Code
42223
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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