SuicideBSANCT03571750
Building Stronger Allies
A study testing Building Stronger Allies and Health Education Training in people with Suicide and Risk Reduction, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Risk Reduction
- What is being tested?
- Building Stronger Allies and Health Education Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
101st Airborne Division (Air Assault) Combat Aviation Brigade
Fort Campbell North, Kentucky, 42223
About this study
Official title: "Building Stronger Allies": Development and Evaluation of a Web Application Targeting Interpersonal Risk Factors for Suicide in Active Duty Service Members
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.
Read the 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.
- Conditions
- Suicide, Risk Reduction
- Being tested
- Building Stronger Allies, Health Education Training
- Keywords
- Suicide, Prevention, Risk Factor, Intervention, Military
- Medical subject headings
- Suicide, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Stronger AlliesBehavioural
Also called BSA
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 TrainingBehavioural
Also called HET
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.
| Study group | Role | What they receive |
|---|---|---|
| Building Stronger Allies Condition | Experimental | 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. Receives: Behavioral: Building Stronger Allies |
| Health Education Training Condition | Placebo comparator | 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. Receives: Behavioral: Health Education Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to year three of the study
Suicide Bereavement (ASF)
1 item created by the MSRC to obtain information regarding the experience of knowing someone who died by suicide.
Measured: Up to year three of the study
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)
Measured: Up to year three of the study
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).
Measured: Up to year three of the study
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).
Measured: Up to year three of the study
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).
Measured: Up to year three of the study
Suicide Attempt History (SHF)
6 items created by the MSRC to assess history of suicide attempts, most lethal attempt, and non-suicidal self-injury.
Measured: Up to year three of the study
Suicide Intensity Ratings (SIR)
3 items to assess current intent and desire to die by suicide, as well as current intensity of suicidal ideation.
Measured: Up to year three of the study
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.
Measured: Up to year three of the study
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.
Measured: Up to year three of the study
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.
Measured: Up to year three of the study
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
Measured: Up to year three of the study
Secondary outcomes (26)
Attentional Control Scale (ACS)
20-item measure that assesses the differences in voluntary attentional control (Derryberry \& Rothbart, 1988).
Measured: Up to year three of the study
Anxiety Sensitivity Index - 3 (ASI-3)
18-item measure of anxiety sensitivity, or fears of anxiety related sensations (Taylor et al., 2007).
Measured: Up to year three of the study
Anxiety and Stress Sensitivity (ASS)
26-item measure of anxiety, fear, or distress caused by a variety of symptoms or bodily sensations.
Measured: Up to year three of the study
Alcohol Use Disorders Identification Test (AUDIT)
10-item measure of alcohol use and frequency of related problems or consequences (Saunders et al., 1993).
Measured: Up to year three of the study
Beck Anxiety Inventory (BAI)
21-item measure of general anxiety symptomatology (Beck et al.,1988).
Measured: Up to year three of the study
Beck Depression Inventory (BDI-II)
21-item measure that assesses severity of depressive symptomatology (Beck et al., 1988).
Measured: Up to year three of the study
Beck Hopelessness Scale (BHS)
current study will use 3 of the 20 items in this measure to assess hopelessness (Beck et al., 1974)
Measured: Up to year three of the study
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)
Measured: Up to year three of the study
Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)
3-item measure about possession of firearms.
Measured: Up to year three of the study
Client Expectancy Questionnaire (CEQ)
8-item questionnaire measuring treatment expectancy and rationale credibility for use in clinical outcome studies (Devilly \& Borkovec, 2000).
Measured: Up to year three of the study
Client Satisfaction Questionnaire (CSQ)
8-item measure assessing general satisfaction with services of treatment received by the individual (Attkisson \& Zwick, 1982)
Measured: Up to year three of the study
DARTS Quiz
11-item measure assessing general satisfaction with an intervention by asking questions regarding presentation, applicability, and acceptability
Measured: Up to year three of the study
Disturbing Dream and Nightmare Severity Index (DDNSI)
up to 16-item measure of nightmare severity and frequency (Krakow et al., 2002)
Measured: Up to year three of the study
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).
Measured: Up to year three of the study
Drug Use Questions (DUQ)
2 items created by the MSRC to assess frequency of prescription medication abuse and non-prescription/recreational drug use
Measured: Up to year three of the study
Dyadic Adjustment Scale (DAS)
32-item measure of satisfaction in an intimate relationship (Spanier, 1976).
Measured: Up to year three of the study
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.
Measured: Up to year three of the study
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).
Measured: Up to year three of the study
*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).
Measured: Up to year three of the study
Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)
10-item measure of levels of negative affect (Watson et al., 1988).
Measured: Up to year three of the study
PTSD Checklist for DSM-5 (PCL-5)
20-item measure of symptoms of PTSD (Blevins et al., 2015).
Measured: Up to year three of the study
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)
Measured: Up to year three of the study
Sheehan Disability Scale (SDS)
4-item measure assessing degree of impairment and disability in several main life areas (Sheehan, 1983)
Measured: Up to year three of the study
Social Interaction Anxiety Scale (SIAS)
20-item measure assessing fears of general social interactions (Mattick \& Clarke, 1998).
Measured: Up to year three of the study
Traumatic Brain Injury - 4 (TBI-4)
4-items to screen for potential traumatic brain injuries (Brenner et al., 2012).
Measured: Up to year three of the study
Use of Behavioral Health Services (UBHS)
2 items created by the MSRC to assess the effects of psychotherapy.
Measured: Up to year three of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start1 May 2019
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 510 participants will be randomly assigned to one of two conditions (1) BSA or (2) HET Control.
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
- Investigators
- Lora R Hunter, PhD, Study chair, Medical Service Corps, United States Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571750
- Sponsor's protocol ID
- W81XWH-16-2-003
- Acronym
- BSA
- Status last verified
- Apr 2022
- First submitted
- 21 May 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Building Stronger Allies": Development and Evaluation of a Web Application Targeting Interpersonal Risk Factors for Suicide in Active Duty Service Members
- ClinicalTrials.gov ID
- NCT03571750
- Acronym / sponsor ID
- BSA / W81XWH-16-2-003
- Conditions
- Suicide, Risk Reduction
- Keywords
- Suicide, Prevention, Risk Factor, Intervention, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 510 participants will be randomly assigned to one of two conditions (1) BSA or (2) HET Control.
| Arm | Type | Receives |
|---|---|---|
| Building Stronger Allies Condition | Experimental | Behavioral: Building Stronger AlliesBSA 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 Condition | Placebo comparator | Behavioral: Health Education TrainingIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Stronger AlliesAlso: BSABSA 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. | Behavioural | Building Stronger Allies Condition |
| Health Education TrainingAlso: HETIn 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. | Behavioural | Health Education Training Condition |
Primary outcome
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
26 secondary outcomes
Attentional Control Scale (ACS)
Time frame: Up to year three of the study
Anxiety Sensitivity Index - 3 (ASI-3)
Time frame: Up to year three of the study
Anxiety and Stress Sensitivity (ASS)
Time frame: Up to year three of the study
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Up to year three of the study
Beck Anxiety Inventory (BAI)
Time frame: Up to year three of the study
Beck Depression Inventory (BDI-II)
Time frame: Up to year three of the study
Beck Hopelessness Scale (BHS)
Time frame: Up to year three of the study
Buss-Perry Aggression Questionnaire - Anger Subscale (BPAQ)
Time frame: Up to year three of the study
Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System State (BRFSS)
Time frame: Up to year three of the study
Client Expectancy Questionnaire (CEQ)
Time frame: Up to year three of the study
Client Satisfaction Questionnaire (CSQ)
Time frame: Up to year three of the study
DARTS Quiz
Time frame: Up to year three of the study
Disturbing Dream and Nightmare Severity Index (DDNSI)
Time frame: Up to year three of the study
Demographics
Time frame: Up to year three of the study
Drug Use Questions (DUQ)
Time frame: Up to year three of the study
Dyadic Adjustment Scale (DAS)
Time frame: Up to year three of the study
Engagement in Behavioral Health Treatment (EBHT)
Time frame: Up to year three of the study
Interpersonal Needs Questionnaire (INQ-R)
Time frame: Up to year three of the study
*Insomnia Severity Index (ISI)
Time frame: Up to year three of the study
Positive and Negative Affect Scale - Negative Affect Subscale (PANAS-NA)
Time frame: Up to year three of the study
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Up to year three of the study
Relationship Closeness Inventory (RCI)
Time frame: Up to year three of the study
Sheehan Disability Scale (SDS)
Time frame: Up to year three of the study
Social Interaction Anxiety Scale (SIAS)
Time frame: Up to year three of the study
Traumatic Brain Injury - 4 (TBI-4)
Time frame: Up to year three of the study
Use of Behavioral Health Services (UBHS)
Time frame: Up to year three of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora R Hunter, PhD study chair
Medical Service Corps, United States Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Stronger Allies and Health Education Training in people with Suicide and Risk Reduction, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD) (time frame: Up to year three of the study). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.