Back to resultsStudy About Group and Phone Follow-Up After a Crisis
Primary Purpose
Suicide, Crisis; Emotional
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)
Discharge / Safety Planning
Sponsored by
About this trial
This is an interventional treatment trial for Suicide
Eligibility Criteria
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 two persons 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.
Sites / Locations
- Connections Health-Urgent Psychiatric Center
- Connections Health-Crisis Response Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
THRIVE + Discharge / Safety Planning
Discharge / Safety Planning Alone
Arm Description
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.
Participants assigned to the control condition will receive Discharge/Safety Planning as it is practiced by Connections Health Solutions per industry best practices.
Outcomes
Primary Outcome Measures
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
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.
Perceived Burdensomeness
Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Perceived Burdensomeness
Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Thwarted Belongingness
Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Thwarted Belongingness
Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Secondary Outcome Measures
Full Information
NCT ID
NCT05637203
First Posted
November 23, 2022
Last Updated
November 23, 2022
Sponsor
University of Rochester
Collaborators
Centerstone Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05637203
Brief Title
Study About Group and Phone Follow-Up After a Crisis
Official Title
Study About Group and Phone Follow-Up After a Crisis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Centerstone Research Institute
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Crisis; Emotional
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
THRIVE + Discharge / Safety Planning
Arm Type
Experimental
Arm Description
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.
Arm Title
Discharge / Safety Planning Alone
Arm Type
Active Comparator
Arm Description
Participants assigned to the control condition will receive Discharge/Safety Planning as it is practiced by Connections Health Solutions per industry best practices.
Intervention Type
Behavioral
Intervention Name(s)
THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Discharge / Safety Planning
Intervention Description
A written safety plan completed with the person
Mental health appointment scheduled within seven days
One phone follow-up call within 30 days
Primary Outcome Measure Information:
Title
Treatment Initiation
Description
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
Time Frame
1 month after discharge
Title
Treatment Initiation
Description
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.
Time Frame
3 months after discharge
Title
Perceived Burdensomeness
Description
Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Time Frame
1 month after discharge
Title
Perceived Burdensomeness
Description
Perceived Burdensomeness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Time Frame
3 months after discharge
Title
Thwarted Belongingness
Description
Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Time Frame
1 month
Title
Thwarted Belongingness
Description
Thwarted Belongingness Items of Interpersonal Needs Questionnaire. Scale has 5 items scored 0 to 2. Range= 0-10 (lower=better outcome)
Time Frame
3 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 two persons 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Lockman, PhD
Phone
615-830-2413
Email
jennifer.lockman@centerstone.org
Facility Information:
Facility Name
Connections Health-Urgent Psychiatric Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
850007
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Balfour, MD
Phone
972-251-0616
Email
Margie.Balfour@connectionshs.com
Facility Name
Connections Health-Crisis Response Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85714
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Balfour, MD
Phone
972-251-0616
Email
Margie.Balfour@connectionshs.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
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.
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.
Learn more about this trial
Study About Group and Phone Follow-Up After a Crisis
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