SuicideNCT04084756
Couples Intervention to Improve Mental Health
A study testing Couples Crisis Response Plan and Mental Health Education in people with Suicide, run by Wesleyan University at 1 site in United States.
Trial summary
Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Couples Crisis Response Plan and Mental Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- military service member (active duty or veteran) of any branch or component that has served since 9/11/2001 or the partner of such a service member;
- that the service member reports active suicide ideation and/or a suicide attempt within the previous 30 days;
- that the service member is in a committed, exclusive, cohabiting relationship of at least 6 months;
- the willingness of the service member's partner to participate in research.
Who cannot join
- a psychiatric condition, medical condition, or cognitive disability/deficit that precludes the ability of either partner to provide informed consent
- physical aggression within the past year reported by either partner on a behaviorally-anchored screener for moderate to severe partner violence or extreme relationship distress (a score of of less than 9 on the Couples Satisfaction Index-4)
- inability of either partner to read or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Salt Lake Behavioral Health
Salt Lake City, Utah, 84111
About this study
Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment. The study's objectives are to test the effect of the CCRP, a targeted single session couples intervention on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the 6 months immediately postdischarge from a psychiatric inpatient unit.
Read the detailed description
Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment, however no couple-bases suicide-specific interventions exist.
The study's objectives are to test the effect of the Couples Crisis Response Plan (CCRP), a targeted single-session couples intervention, on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the period of time immediately post-discharge from a psychiatric inpatient unit. The CCRP will be compared to an active control condition (mental health education).
The primary aim is to compare the effect of the CCRP to an active control condition on suicide ideation in the 6 months following treatment among military service members and Veterans who have been psychiatrically hospitalized for acute suicide risk and their partners. The CCRP is specifically adapted for use with partnered service members at elevated risk for suicide. A secondary aim is to determine how use of the CCRP skills impacts suicidal ideation over time and identify the role partners play in encouraging use of the plan and managing suicide risk.
- Conditions
- Suicide
- Being tested
- Couples Crisis Response Plan, Mental Health Education
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Crisis Response PlanBehavioural
The CCRP is a single session therapist-facilitated suicide prevention intervention conducted with a dyad
Mental Health EducationBehavioural
The Mental Health Education session is a single session therapist-facilitated mental health psychoeducation session conducted with a dyad
| Study group | Role | What they receive |
|---|---|---|
| Couples Crisis Response Plan | Experimental | Not described Receives: Behavioral: Couples Crisis Response Plan |
| Mental Health Education | Active comparator | Not described Receives: Behavioral: Mental Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
Self-report assessment of severity of suicidal thoughts and behaviors. Items 1-19 are summed (range: 0-38) and higher scores indicate greater suicide severity. Measured at baseline, hospital discharge, and 1, 3, and 6 month follow ups.
Measured: Assessed at baseline and 1, 3 and 6-months follow ups
Secondary outcomes (1)
Change in number of suicide attempts from baseline
The change in number of suicide attempts from baseline will be assessed through participants' responses to the Self-Injurious Thoughts and Behaviors Interview. The Self-Injurious Thoughts and Behaviors Interview is a structured interview assessing history of suicidal thoughts and behaviors, including suicide attempt history (dates, methods, and severity (e.g., need for medical attention) of previous suicide attempts). An increased number of suicide attempts at any assessment is considered a worse outcome.
Measured: Assessed at baseline and 1, 3 and 6-months follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Aug 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wesleyan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Military Suicide Research Consortium
- Responsible party
- Principal investigator, Alexis May, Wesleyan University
- Investigators
- Alexis May, PhD, Principal investigator, Wesleyan UniverityCraig Bryan, PsyD, APBB, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084756
- Sponsor's protocol ID
- 00113793
- Other IDs
- W81XWH-16-2-0004
- Status last verified
- May 2022
- First submitted
- 3 Sep 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Intervention to Improve Mental Health
- ClinicalTrials.gov ID
- NCT04084756
- Acronym / sponsor ID
- 00113793
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wesleyan UniversityUniversity, hospital or other
- Collaborators
- University of Utah, Military Suicide Research Consortium
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 10 Sep 2019 (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.
Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment. The study's objectives are to test the effect of the CCRP, a targeted single session couples intervention on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the 6 months immediately postdischarge from a psychiatric inpatient unit.
Detailed description
Over the last decade, suicide rates have risen within the military and have remained high. Converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment, however no couple-bases suicide-specific interventions exist.
The study's objectives are to test the effect of the Couples Crisis Response Plan (CCRP), a targeted single-session couples intervention, on suicide ideation among military service members and Veterans, and to understand how the use of the CCRP impacts suicide risk during the period of time immediately post-discharge from a psychiatric inpatient unit. The CCRP will be compared to an active control condition (mental health education).
The primary aim is to compare the effect of the CCRP to an active control condition on suicide ideation in the 6 months following treatment among military service members and Veterans who have been psychiatrically hospitalized for acute suicide risk and their partners. The CCRP is specifically adapted for use with partnered service members at elevated risk for suicide. A secondary aim is to determine how use of the CCRP skills impacts suicidal ideation over time and identify the role partners play in encouraging use of the plan and managing suicide risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples Crisis Response Plan | Experimental | Behavioral: Couples Crisis Response Plan |
| Mental Health Education | Active comparator | Behavioral: Mental Health Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- military service member (active duty or veteran) of any branch or component that has served since 9/11/2001 or the partner of such a service member;
- that the service member reports active suicide ideation and/or a suicide attempt within the previous 30 days;
- that the service member is in a committed, exclusive, cohabiting relationship of at least 6 months;
- the willingness of the service member's partner to participate in research.
Key exclusion criteria (3 listed)
- a psychiatric condition, medical condition, or cognitive disability/deficit that precludes the ability of either partner to provide informed consent
- physical aggression within the past year reported by either partner on a behaviorally-anchored screener for moderate to severe partner violence or extreme relationship distress (a score of of less than 9 on the Couples Satisfaction Index-4)
- inability of either partner to read or speak English
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 |
|---|---|---|
| Couples Crisis Response PlanThe CCRP is a single session therapist-facilitated suicide prevention intervention conducted with a dyad | Behavioural | Couples Crisis Response Plan |
| Mental Health EducationThe Mental Health Education session is a single session therapist-facilitated mental health psychoeducation session conducted with a dyad | Behavioural | Mental Health Education |
Primary outcome
Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
Time frame: Assessed at baseline and 1, 3 and 6-months follow ups
Self-report assessment of severity of suicidal thoughts and behaviors. Items 1-19 are summed (range: 0-38) and higher scores indicate greater suicide severity. Measured at baseline, hospital discharge, and 1, 3, and 6 month follow ups.
1 secondary outcome
Change in number of suicide attempts from baseline
Time frame: Assessed at baseline and 1, 3 and 6-months follow ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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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.
Alexis May, PhD principal investigator
Wesleyan Univerity
Craig Bryan, PsyD, APBB principal investigator
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 Couples Crisis Response Plan and Mental Health Education in people with Suicide, run by Wesleyan 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 May 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. 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?
Results are not available in the source record.
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?
Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation (time frame: Assessed at baseline and 1, 3 and 6-months follow ups). 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 12 May 2022.