- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05637203
Study About Group and Phone Follow-Up After a Crisis
Study Overview
Status
Conditions
Detailed Description
The US is poised for growth and investment in our mental health crisis system, with a national phone/text line launching, accompanied by new funding for crisis services. More than 600 Crisis Stabilization Centers (CSCs) across the US provide suicidal clients with a more comfortable and less costly alternative to Emergency Department (ED) care. In light of rising demand, there is an urgent need for feasible, effective, interpersonal, recovery-oriented interventions. This study adapts and tests a novel intervention for delivery prior to and after discharge from CSCs. THRIVE uses the Interpersonal Theory of Suicide as a framework to bolster social connectedness and counter perceived burdensomeness.
Preliminary data shows promising results. However, CSC workflows and culture require context-specific adaptation. This study leverages the Model for Adaptation Design and Impact to adapt THRIVE for CSCs, test feasibility, acceptability, and appropriateness, and conduct a pilot RCT in two CSCs. The CSC-adapted intervention addresses interpersonal drivers of suicide risk and bolsters safety, recovery, and community linkage through: (a) a 'belonging and giving' group during CSC stay, (b) recovery coaching calls for 4 weeks post-discharge, and (c) an optional phone app that provides reinforcement and resources for connection. The pilot will compare THRIVE + Discharge/Safety Planning (D/SP) to D/SP alone, examining the degree to which THRIVE engages the targeted mechanisms of change at one- and three-months post-discharge.
Aim 1. Adapt THRIVE and complete CSC-specific manual using MADI.
Aim 2. Test feasibility, acceptability, appropriateness of THRIVE for CSCs. CSC Guests (n = 20). 75% of guests will participate in a THRIVE group and at least one follow-up session within one month of discharge. Ratings of acceptability and satisfaction will be ≧ 75%.
CSC Staff (n = 4). Fidelity ratings of audio recordings of group and coaching calls with be at least
≧ 75% for all staff who deliver THRIVE. CSC Administrators will rate acceptability and appropriateness of THRIVE for CSCs as ≧ 75%.
Aim 3. Conduct a randomized pilot effectiveness trial (n = 100) to assess the effect of THRIVE on treatment initiation and on key interpersonal drivers of suicide - belongingness and burdensomeness. We hypothesize that CSC guests who receive THRIVE + D/SP vs. D/SP alone will have:
H1: Higher rates of treatment initiation at 1 month and 3 months from CSC discharge.
H2. Increased belongingness and decreased burdensomeness at 1 and 3 months after discharge.
We will explore the effect of the intervention on treatment engagement, acute care psychiatric readmissions, and suicidal ideation and suicidal behavior over 3-month follow-up. At the end of the study, THRIVE for CSCs will be ready to test in an effectiveness trial for preventing suicidal behavior.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 850007
- Connections Health-Urgent Psychiatric Center
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Tennessee
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Nashville, Tennessee, United States, 37228
- Mental Health Cooperative
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under age 18.
- Inability to communicate with the researcher in English.
- Acute psychiatric instability (e.g., psychotic symptoms). Most patients with psychosis are transferred to Emergency Departments instead of CSCs, so we do not expect many exclusions based on this criterion.
- Inability to access a phone to participate in phone follow-up program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: THRIVE + Discharge / Safety Planning
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.
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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.
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Active Comparator: Discharge / Safety Planning Alone
Participants assigned to the control condition will receive Discharge/Safety Planning as it is practiced by Connections Health Solutions per industry best practices.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment Initiation
Time Frame: 1 month after discharge
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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
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1 month after discharge
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Treatment Initiation
Time Frame: 3 months after discharge
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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.
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3 months after discharge
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Perceived Burdensomeness
Time Frame: 1 month after discharge
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Perceived Burdensomeness Items of Interpersonal Needs Questionnaire.
Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
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1 month after discharge
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Perceived Burdensomeness
Time Frame: 3 months after discharge
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Perceived Burdensomeness Items of Interpersonal Needs Questionnaire.
Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
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3 months after discharge
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Thwarted Belongingness
Time Frame: 1 month
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Thwarted Belongingness Items of Interpersonal Needs Questionnaire.
Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
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1 month
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Thwarted Belongingness
Time Frame: 3 months after discharge
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Thwarted Belongingness Items of Interpersonal Needs Questionnaire.
Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
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3 months after discharge
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00007664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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