- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558891
Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers (THRIVE)
July 2, 2024 updated by: Jordan Nelon, Centerstone Research Institute
THRIVE: Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers
Crisis Stabilization Centers (CSCs) have a unique role to play in Emergency Department diversion and suicide-specific care.
However, brief interventions tailored for CSC settings are needed.
This study will examine a new, 60-minute, narrative, technology-based, recovery-oriented intervention called THRIVE.
THRIVE may help people make meaning of their suicide crisis, reduce suicidal ideation, and increase their recovery compared to usual care.
If effective, THRIVE will help CSCs deliver better recovery-focused care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
More than 5.3 million individuals at risk for suicide seek treatment through emergency departments (EDs) each year despite the fact that EDs are not well suited for their care.
Crisis Stabilization Centers (CSCs) have been proposed as a person-centered alternative to EDs.
More than 600 CSCs nationwide operate 24 hours per day, accept walk-ins, provide care regardless of ability to pay, and partner with local law enforcement to divert suicidal patients from EDs.
However, research outcomes on CSCs are mixed, likely associated with the fact that brief, recovery-oriented interventions with the potency to decrease suicide attempts and deaths are needed in CSCs but do not exist.
Toward recovery, hope, recovery, interpersonal growth, values, and engagement (THRIVE) is a 60 minute intervention developed by the Principal Investigator and CSC stakeholders.
THRIVE is uniquely tailored to CSC workflows and helps guests increase hopefulness, make meaning from stressful life events, and promote self-efficacy to prevent suicide attempts.
In THRIVE, the guest is asked to narrate the suicide crisis, make meaning of the crisis through building an autobiographical timeline, and construct actionable future goals through an building an interactive meaningful living plan.
THRIVE is conducted via a tablet so that all materials can be saved electronically in a HIPAA-compliant cloud to support providers in collaborating on care goals during and after discharge.
The goal of this project is to fill a critical gap in the crisis stabilization literature by testing THRIVE as a novel solution to maximize the effectiveness of CSCs.
This study will address the following aims: 1) Examine the feasibility, acceptability, and ecological validity of THRIVE as a unique fit for CSC guests (n = 30) and staff; 2) Conduct a pilot randomized trial (n = 150) to examine the degree to which THRIVE engages proposed recovery-oriented mechanisms of change relevant to the unique treatment philosophies of CSC settings; 3) As part of the pilot randomized trial, compare the outcomes of THRIVE + Usual Care (THRIVE + UC) to the outcomes of Usual Care (UC) delivered in the CSC (i.e., on recovery orientation, suicidal ideation, resolved suicide plans and preparation, treatment engagement, and acute psychiatric re-admissions).
In Phase I (Aim 1), participants will be administered quantitative surveys after experiencing the THRIVE intervention.
In Phase II (Aims, 2-3), participants in the RCT will be administered surveys at baseline, discharge, 1 month follow-up, and 3-month follow-up time points.
CSCs represent the future of suicide-specific care and THRIVE is a novel intervention with the potential to impact more than 5.3 million individuals in a highly lethal group - suicidal individuals seeking care at EDs diverted to CSCs.
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37228
- Mental Health Cooperative
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Admitted to the crisis stabilization center (CSC)
- Davidson county resident
- English-speaking
- Able to provide informed consent
- Willing to complete a locator form for follow-up assessments
- Willing to complete two emergency contacts
- Medically and clinically cleared by onsite psychiatrist/nurse practitioner
- Increased risk for suicide (Patient safety screener-3, Item 2 and/or 3 is "Yes")
- Willing and able to discuss their experiences around suicidal thoughts and/or attempts
Exclusion Criteria:
- Individuals who are acutely psychotic
- Individuals unable to communicate with the research team
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: THRIVE + Usual Care
Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
|
Toward Hope, Recovery, Interpersonal Relationships, Values and Engagement (THRIVE), is a brief, suicide-specific, narrative, recovery-focused, 60 minute intervention.
THRIVE includes three components: 1) Sharing the suicide narrative; 2) Completing the Lifeline and Meaning Reconstruction; 3) Completing the Meaningful Living Plan (MLP).
Care as Usual in this Crisis Stabilization Unit includes medication management, medication management, safety planning Intervention, group psychoeducation, discharge planning, and community linkages
|
|
Active Comparator: Usual Care
Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
|
Care as Usual in this Crisis Stabilization Unit includes medication management, medication management, safety planning Intervention, group psychoeducation, discharge planning, and community linkages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meaning made of stress
Time Frame: 3 months
|
Integration of Stressful Life Experiences Scale (ISLES; Holland et al., 2010).
Subscale scores range from 11 to 55 (Footing in the World subscale), 5 to 25 (Comprehensibility subscale) and 16 to 80 (Total ISLES score).
Higher scores on each ISLES subscale and the ISLES total score represent greater meaning reconstruction.
|
3 months
|
|
Hopefulness
Time Frame: 3 months
|
Adult State Hope Scale (ASHS; Snyder et al., 1996).
Subscale scores range from 3 to 34 (Pathways subscale), from 3 to 24 (Agency subscale), and from 6 to 48 (Total Hope Score).
Higher scores on each ASHS subscale and the ASHS total score represent higher levels of hope.
|
3 months
|
|
Self-efficacy to avoid suicidal action
Time Frame: 3 months
|
Self-Efficacy to Avoid Suicidal Action Scale (SEASA; Czyz et al., 2014).
The total score on the SEASA ranges from 0 to 54, with higher levels presenting higher self-efficacy to avoid suicidal action.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Lockman, PhD, Centerstone Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2022
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
June 30, 2022
First Submitted That Met QC Criteria
September 23, 2022
First Posted (Actual)
September 28, 2022
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CenterstoneRI
- YIG-0-113-20 (Other Grant/Funding Number: American Foundation for Suicide Prevention)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
VA Office of Research and DevelopmentRecruitingSuicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation | Suicide | Suicide AttemptUnited States
Clinical Trials on THRIVE
-
Colorado School of Public HealthUniversity of Colorado, Denver; CU Thrive: Office for Well-being | Center for...Not yet recruitingBurnout | Leadership | Professional Fulfillment | Belonging | Intent to LeaveUnited States
-
Hada Fongha Ieong, PhDRotary Club of BarbadosNot yet recruitingPregnancy in AdolescenceBarbados
-
University of PennsylvaniaAgency for Healthcare Research and Quality (AHRQ)RecruitingCare TransitionsUnited States
-
University of PennsylvaniaRita & Alex Hillman FoundationEnrolling by invitationCare TransitionsUnited States
-
Montana State UniversityCompletedDepressive SymptomsUnited States
-
Patrick C. Johnson, MDRecruiting
-
SABA AL-SULTTANCompletedPre-oxygenation in Term Pregnant WomenUnited Kingdom
-
Medical College of WisconsinChildren's National Research InstituteTerminatedFailure to ThriveUnited States
-
Children's Hospital Medical Center, CincinnatiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingObesity | Weight Gain | Obesity, Childhood | Weight Gain TrajectoryUnited States
-
Edinburgh Napier UniversityNot yet recruitingComplex Post-Traumatic Stress Disorder