Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers (THRIVE)

• ClinicalTrials.gov Identifier: NCT05558891
• Recruitment Status: Recruiting
• First Posted: September 28, 2022
• Last Update Posted: November 25, 2022
• Sponsor: Centerstone Research Institute
• Collaborator: University of Rochester
• Information provided by (Responsible Party): Jennifer D. Lockman, PhD, Centerstone Research Institute

Tracking Information

• First Submitted Date: June 30, 2022
• First Posted Date: September 28, 2022
• Last Update Posted Date: November 25, 2022
• Actual Study Start Date: June 22, 2022
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2022)

• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: September 23, 2022)

• Meaning made of stress [ Time Frame: 3 months ]
  Integration of Stressful Life Experiences Scale (ISLES; Holland et al., 2010)
• Hopefulness [ Time Frame: 3 months ]
  Adult State Hope Scale (Snyder et al., 1996)
• Self-efficacy to avoid suicidal action [ Time Frame: 3 months ]
  Self-Efficacy to Avoid Suicidal Action Scale (SEASA; Czyz et al., 2014)

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers
• Official Title: THRIVE: Pilot Study of a Brief, Recovery-focused Intervention for Crisis Stabilization Centers
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Suicide

Intervention

• Behavioral: THRIVE
  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).
• Behavioral: Usual Care
  Care as Usual in this Crisis Stabilization Unit includes medication management, medication management, safety planning Intervention, group psychoeducation, discharge planning, and community linkages

Study Arms

• 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
  Interventions:

  • Behavioral: THRIVE
  • Behavioral: Usual Care
• Active Comparator: Usual Care
  Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk
  Intervention: Behavioral: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 23, 2022): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2024
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jennifer D Lockman, PhD; 615-830-2413; Jennifer.Lockman@Centerstone.org

Contact: Anthony R Pisani, PhD; (585) 275-3644; Anthony_Pisani@urmc.rochester.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05558891
• Other Study ID Numbers: CenterstoneRI; YIG-0-113-20 ( Other Grant/Funding Number: American Foundation for Suicide Prevention )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jennifer D. Lockman, PhD, Centerstone Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Centerstone Research Institute
• Original Study Sponsor: Same as current
• Collaborators: University of Rochester

Investigators

• Principal Investigator: Jennifer Lockman, PhD; Centerstone Research Institute

• PRS Account: Centerstone Research Institute
• Verification Date: November 2022