Clinical trial NCT05637203: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Suicide
Crisis; Emotional
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Centerstone Research Institute
First posted: 2022-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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:

1. Under age 18.
2. Inability to communicate with the researcher in English.
3. 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.
4. Inability to access a phone to participate in phone follow-up program.

Primary outcomes:
measure: Treatment Initiation
timeFrame: 1 month after discharge
measure: Treatment Initiation
timeFrame: 3 months after discharge
measure: Perceived Burdensomeness
timeFrame: 1 month after discharge
measure: Perceived Burdensomeness
timeFrame: 3 months after discharge
measure: Thwarted Belongingness
timeFrame: 1 month
measure: Thwarted Belongingness
timeFrame: 3 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Connections Health-Urgent Psychiatric Center
state: Arizona
city: Nashville
country: United States
facility: Mental Health Cooperative
state: Tennessee
Study officials:
References: