SuicideBISSRNCT02042131
Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations
A study testing Treatment As Usual (TAU), Standard Crisis Response Plan (S-CRP) and Enhanced Crisis Response Plan (E-CRP) in people with Suicide and Suicidal Ideation, run by University of Utah at 1 site in United States.
Trial summary
The purpose of the proposed study is to identify the most effective brief interventions for reducing short-term risk for suicide attempts in "real world" military triage settings, and to identify potential mechanisms of change underlying the interventions' impact on subsequent suicide attempts. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Suicidal Ideation
- What is being tested?
- Treatment As Usual (TAU), Standard Crisis Response Plan (S-CRP) and Enhanced Crisis Response Plan (E-CRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active duty
- 18 years of age or older
- Reporting current suicidal ideation with intent to die, or a suicide attempt within the past two weeks
- Able to speak and understand the English language
- Able to complete the informed consent process
Who cannot join
- Severe psychiatric or medical conditions that preclude the ability to provide informed consent or participation in outpatient treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed study is to identify the most effective brief interventions for reducing short-term risk for suicide attempts in "real world" military triage settings, and to identify potential mechanisms of change underlying the interventions' impact on subsequent suicide attempts. We will randomize 360 patients to one of three commonly-used crisis interventions delivered as routine care in the mental health triage system: (1) Treatment As Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan with Reasons For Living (E-CRP). The following hypotheses will be tested:
- The enhanced crisis response plan (E-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to the standard crisis response plan alone (S-CRP) and treatment as usual (TAU).
- The standard crisis response plan (S-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to treatment as usual (TAU).
- Greater ambivalence about suicide and faster recall of reasons for living will mediate the relationship between intervention and reduced risk for suicide attempt during follow-up.
Read the detailed description
The CRP has been proposed as an alternative to TAU for the short-term management of suicidal patients and is now in widespread use, but has never been empirically tested. The CRP is purported to reduce suicide risk via unique mechanisms that directly suicide risk, notably suicidal ambivalence (i.e., the relative balance between the wish to live and the wish to die) and problem solving. Because suicidal ambivalence has gained support as an active mechanism for reducing suicide risk, the present study will also seek to augment this underlying mechanism by directly engaging the suicidal patient in a discussion about their reasons for living, thereby potentially increasing the potency of the CRP.
The present study therefore entails a component analysis of crisis interventions. As such, we anticipate ordered effects, whereby the S-CRP and E-CRP conditions will show significantly better outcomes than TAU, and E-CRP will demonstrate significantly better outcomes than the standard CRP condition.
- Conditions
- Suicide, Suicidal Ideation
- Being tested
- Treatment As Usual (TAU), Standard Crisis Response Plan (S-CRP), Enhanced Crisis Response Plan (E-CRP)
- Keywords
- suicide, suicidal ideation, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, veteran, clinical trial, cognitive behavioral therapy, psychotherapy, crisis, Treatment As Usual (TAU), Crisis Response Plan (CRP), Enhanced Crisis Response Plan (E-CRP)
- Medical subject headings
- Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As Usual (TAU)Behavioural
Also called Usual Care, Enhanced Care, Enhanced Care As Usual
Standard Crisis Response Plan (S-CRP)Behavioural
Also called Safety Plan
Enhanced Crisis Response Plan (E-CRP)Behavioural
Also called Safety Plan
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety Receives: Behavioral: Treatment As Usual (TAU) |
| Standard Crisis Response Plan (S-CRP) | Experimental | CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources Receives: Behavioral: Standard Crisis Response Plan (S-CRP); Behavioral: Enhanced Crisis Response Plan (E-CRP) |
| Enhanced Crisis Response Plan (E-CRP) | Experimental | The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources Receives: Behavioral: Enhanced Crisis Response Plan (E-CRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Proportion of Participants With Suicide Attempt
Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent
Measured: 6 months
Secondary outcomes (2)
Beck Scale for Suicide Ideation (BSSI)
The BSSI is used to evaluate the intensity of the patient's specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation.
Measured: 1 month, 3 months, and 6 months
Inpatient Psychiatric Hospitalization Days
Mean number of days of inpatient psychiatric hospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Bryan, University of Utah
- Investigators
- Craig J Bryan, PsyD, ABPP, Principal investigator, National Center for Veterans Studies & The University of UtahTracy A Clemans, PsyD, Study director, National Center for Veterans Studies & The University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042131
- Sponsor's protocol ID
- R01481
- Other IDs
- W81XWH-10-2-0181
- Acronym
- BISSR
- Status last verified
- Aug 2017
- First submitted
- 17 Jan 2014
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.
PubMed 28967323Lowder EM, Rade CB, Desmarais SL. Effectiveness of Mental Health Courts in Reducing Recidivism: A Meta-Analysis. Psychiatr Serv. 2018 Jan 1;69(1):15-22. doi: 10.1176/appi.ps.201700107. Epub 2017 Aug 15.
PubMed 28806894
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations
- ClinicalTrials.gov ID
- NCT02042131
- Acronym / sponsor ID
- BISSR / R01481
- Conditions
- Suicide, Suicidal Ideation
- Keywords
- suicide, suicidal ideation, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 11 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to identify the most effective brief interventions for reducing short-term risk for suicide attempts in "real world" military triage settings, and to identify potential mechanisms of change underlying the interventions' impact on subsequent suicide attempts. We will randomize 360 patients to one of three commonly-used crisis interventions delivered as routine care in the mental health triage system: (1) Treatment As Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan with Reasons For Living (E-CRP). The following hypotheses will be tested:
- The enhanced crisis response plan (E-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to the standard crisis response plan alone (S-CRP) and treatment as usual (TAU).
- The standard crisis response plan (S-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to treatment as usual (TAU).
- Greater ambivalence about suicide and faster recall of reasons for living will mediate the relationship between intervention and reduced risk for suicide attempt during follow-up.
Detailed description
The CRP has been proposed as an alternative to TAU for the short-term management of suicidal patients and is now in widespread use, but has never been empirically tested. The CRP is purported to reduce suicide risk via unique mechanisms that directly suicide risk, notably suicidal ambivalence (i.e., the relative balance between the wish to live and the wish to die) and problem solving. Because suicidal ambivalence has gained support as an active mechanism for reducing suicide risk, the present study will also seek to augment this underlying mechanism by directly engaging the suicidal patient in a discussion about their reasons for living, thereby potentially increasing the potency of the CRP.
The present study therefore entails a component analysis of crisis interventions. As such, we anticipate ordered effects, whereby the S-CRP and E-CRP conditions will show significantly better outcomes than TAU, and E-CRP will demonstrate significantly better outcomes than the standard CRP condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment As Usual (TAU)TAU includes the following intervention components: 1. suicide risk assessment 2. supportive listening 3. provision of professional and crisis contact information 4. referral to mental health treatment and community resources 5. verbal contract for safety |
| Standard Crisis Response Plan (S-CRP) | Experimental | Behavioral: Standard Crisis Response Plan (S-CRP), Behavioral: Enhanced Crisis Response Plan (E-CRP)CRP includes the following intervention components: 1. suicide risk assessment 2. supportive listening 3. identify personal warning signs 4. identify self-management skills 5. identify social support contacts 6. provision of professional and crisis contact information 7. referral to mental health treatment and community resources |
| Enhanced Crisis Response Plan (E-CRP) | Experimental | Behavioral: Enhanced Crisis Response Plan (E-CRP)The E-CRP includes the following intervention components: 1. suicide risk assessment 2. supportive listening 3. identify personal warning signs 4. identify self-management skills 5. identify reasons for living 6. identify social support contacts 7. provision of professional and crisis contact information 8. referral to mental health treatment and community resources |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active duty
- 18 years of age or older
- Reporting current suicidal ideation with intent to die, or a suicide attempt within the past two weeks
- Able to speak and understand the English language
- Able to complete the informed consent process
Key exclusion criteria (1 listed)
- Severe psychiatric or medical conditions that preclude the ability to provide informed consent or participation in outpatient treatment
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 |
|---|---|---|
| Treatment As Usual (TAU)Also: Usual Care, Enhanced Care, Enhanced Care As Usual | Behavioural | Treatment As Usual (TAU) |
| Standard Crisis Response Plan (S-CRP)Also: Safety Plan | Behavioural | Standard Crisis Response Plan (S-CRP) |
| Enhanced Crisis Response Plan (E-CRP)Also: Safety Plan | Behavioural | Enhanced Crisis Response Plan (E-CRP), Standard Crisis Response Plan (S-CRP) |
Primary outcome
Estimated Proportion of Participants With Suicide Attempt
Time frame: 6 months
Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent
2 secondary outcomes
Beck Scale for Suicide Ideation (BSSI)
Time frame: 1 month, 3 months, and 6 months
Inpatient Psychiatric Hospitalization Days
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28967323Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.
- Derived from this study: PubMed 28806894Lowder EM, Rade CB, Desmarais SL. Effectiveness of Mental Health Courts in Reducing Recidivism: A Meta-Analysis. Psychiatr Serv. 2018 Jan 1;69(1):15-22. doi: 10.1176/appi.ps.201700107. Epub 2017 Aug 15.
- National Center for Veterans StudiesLink provided by the sponsor.
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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.
Craig J Bryan, PsyD, ABPP principal investigator
National Center for Veterans Studies & The University of Utah
Tracy A Clemans, PsyD study director
National Center for Veterans Studies & The University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment As Usual (TAU), Standard Crisis Response Plan (S-CRP) and Enhanced Crisis Response Plan (E-CRP) in people with Suicide and Suicidal Ideation, run by University of Utah 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 5 inclusion and 1 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 11 Aug 2017. 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. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Estimated Proportion of Participants With Suicide Attempt (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02042131, which also lists 2 linked publications.
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 11 Aug 2017.