SuicideNCT05637203
Study About Group and Phone Follow-Up After a Crisis
A study testing THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement) and Discharge / Safety Planning in people with Suicide and Crisis; Emotional, run by University of Rochester at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Crisis; Emotional
- What is being tested?
- THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement) and Discharge / Safety Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mental Health Cooperative
Nashville, Tennessee, 37228
Connections Health-Urgent Psychiatric Center
Phoenix, Arizona, 850007
About this study
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.
Read the 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.
- Conditions
- Suicide, Crisis; Emotional
- Being tested
- THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement), Discharge / Safety Planning
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)Behavioural
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.
Discharge / Safety PlanningBehavioural
- A written safety plan completed with the person
- Mental health appointment scheduled within seven days
- One phone follow-up call within 30 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Discharge / Safety Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start23 Sep 2024
- Primary completion28 Feb 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centerstone Research Institute
- Responsible party
- Principal investigator, Anthony Pisani, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637203
- Sponsor's protocol ID
- 00007664
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Group and Phone Follow-Up After a Crisis
- ClinicalTrials.gov ID
- NCT05637203
- Acronym / sponsor ID
- 00007664
- Conditions
- Suicide, Crisis; Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centerstone Research Institute
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE + Discharge / Safety Planning | Experimental | Behavioral: THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)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. |
| Discharge / Safety Planning Alone | Active comparator | Behavioral: Discharge / Safety PlanningParticipants assigned to the control condition will receive Discharge/Safety Planning as it is practiced by Connections Health Solutions per industry best practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)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. | Behavioural | THRIVE + Discharge / Safety Planning |
| 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 | Behavioural | Discharge / Safety Planning Alone |
Primary outcome
Treatment Initiation
Time frame: 1 month after discharge
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
Treatment Initiation
Time frame: 3 months after discharge
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.
Perceived Burdensomeness
Time frame: 1 month after discharge
Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Perceived Burdensomeness
Time frame: 3 months after discharge
Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Thwarted Belongingness
Time frame: 1 month
Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Thwarted Belongingness
Time frame: 3 months after discharge
Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement) and Discharge / Safety Planning in people with Suicide and Crisis; Emotional, run by University of Rochester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Initiation (time frame: 1 month after discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.