Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers (THRIVE)
Primary Purpose
Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THRIVE
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Suicide
Eligibility Criteria
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
Sites / Locations
- Mental Health CooperativeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: THRIVE + Usual Care
Usual Care
Arm Description
Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
Outcomes
Primary Outcome Measures
Meaning made of stress
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.
Hopefulness
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.
Self-efficacy to avoid suicidal action
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05558891
First Posted
June 30, 2022
Last Updated
November 21, 2022
Sponsor
Centerstone Research Institute
Collaborators
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT05558891
Brief Title
Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers
Acronym
THRIVE
Official Title
THRIVE: Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centerstone Research Institute
Collaborators
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: THRIVE + Usual Care
Arm Type
Experimental
Arm Description
Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
Intervention Type
Behavioral
Intervention Name(s)
THRIVE
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Care as Usual in this Crisis Stabilization Unit includes medication management, medication management, safety planning Intervention, group psychoeducation, discharge planning, and community linkages
Primary Outcome Measure Information:
Title
Meaning made of stress
Description
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.
Time Frame
3 months
Title
Hopefulness
Description
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.
Time Frame
3 months
Title
Self-efficacy to avoid suicidal action
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer D Lockman, PhD
Phone
615-830-2413
Email
Jennifer.Lockman@Centerstone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony R Pisani, PhD
Phone
(585) 275-3644
Email
Anthony_Pisani@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Lockman, PhD
Organizational Affiliation
Centerstone Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Cooperative
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Henry, M.S.
Phone
615-743-1468
Email
JHenry@mhc-tn.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers
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