NCT05637203

Brief Summary

Crisis stabilization centers (CSCs) provide a less costly and more comfortable alternative to Emergency Department care for individuals with suicidal crises. With demand for crisis alternatives growing, effective interventions that fit the unique workflows and workforce of CSCs are needed to realize their life-saving potential. To address this need, the investigators will adapt, and pilot test the effectiveness of an interpersonally enhanced recovery and follow-up intervention delivered during and after admissions acute suicidal crises.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 18, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

November 23, 2022

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Treatment Initiation

    Psychological Problem Area subscale of the Treatment Services Review. This scale consists of 5 service review items in which the person states the number of times s/he received a specified service. Outcome of interest is 0 v. \> 0. \>0 = treatment initiation

    1 month after discharge

  • Treatment Initiation

    Psychological Problem Area subscale of the Treatment Services Review. This scale consists of 5 service review items in which the person states the number of times s/he received a specified service. Outcome of interest is 0 v. \> 0. \>0 = treatment initiation.

    3 months after discharge

  • Perceived Burdensomeness

    Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)

    1 month after discharge

  • Perceived Burdensomeness

    Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)

    3 months after discharge

  • Thwarted Belongingness

    Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)

    1 month

  • Thwarted Belongingness

    Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)

    3 months after discharge

Study Arms (2)

THRIVE + Discharge / Safety Planning

EXPERIMENTAL

Participants assigned to the intervention condition will receive THRIVE Crisis Recovery and Care Transition Program, which consists of group-based reflections on "giving and belonging" and a plan for community connection and treatment, followed by 3-4 coaching calls to reinforce and troubleshoot the plans.

Behavioral: THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)

Discharge / Safety Planning Alone

ACTIVE COMPARATOR

Participants assigned to the control condition will receive Discharge/Safety Planning as it is practiced by Connections Health Solutions per industry best practices.

Behavioral: Discharge / Safety Planning

Interventions

THRIVE is an interpersonally focused recovery and care transition program. THRIVE (previously called "RELATE" in our SAMHSA grants) involves engaging a person during and following acute suicidal crisis in a sequence of interpersonally focused therapeutic tasks. The purpose of THRIVE is to help CSC guests re-build connections and "contribute" to the world in ways they find personally meaningful, while also transitioning safely to outpatient, community-based care. THRIVE involves a Belonging and Giving Reflections Group while at the CSC, followed by a 4-week, phone-based, recovery and care transition series of coaching calls.

THRIVE + Discharge / Safety Planning

* A written safety plan completed with the person * Mental health appointment scheduled within seven days * One phone follow-up call within 30 days

Discharge / Safety Planning Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to CSC with suicidal crisis, as defined by active suicide ideation ascertained by the Columbia Suicide-Severity Rating scale, which the sites already routinely administer.
  • Ability and willingness to provide information for and permission to contact one person in case of emergency or inability to reach the participant for follow-up

You may not qualify if:

  • Under age 18.
  • Inability to communicate with the researcher in English.
  • Inability to access a phone to participate in phone follow-up program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Connections Health-Urgent Psychiatric Center

Phoenix, Arizona, 850007, United States

RECRUITING

Mental Health Cooperative

Nashville, Tennessee, 37228, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Suicide

Interventions

NicotineSalvage TherapyDrainage

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Jennifer Lockman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 5, 2022

Study Start

April 18, 2024

Primary Completion

February 28, 2026

Study Completion

April 30, 2026

Last Updated

September 10, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The final dataset that we will share will include self-reported demographic and behavioral data from assessments with subjects as described in the Research Strategy section of this application. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIMH Data Archive (NDA) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA. Data will be of sufficient quality to validate and replicate research findings described in the Aims.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. We will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
Access Criteria
To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. The NDA GUID tool allows researchers to aggregate data from the same research participant without different laboratories having to share personally identifiable information about that research participant. The NDA data dictionaries do not permit personally identifiable information to be shared. NDA maintains a Certificate of Confidentiality.

Locations