Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders

NCT04221269 | Completed

• 1 other identifier: 1908-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The current project is a pilot randomized controlled trial to test the Coping Long-term with Active Suicide Program for schizophrenia-spectrum disorders (CLASP-S) for patients following a psychiatric hospitalization. Participants will be assigned to enhanced treatment as usual (ETAU) alone vs CLASP-S plus ETAU. Participants complete assessments at baseline during their psychiatric hospitalization and at 3 months (mid-treatment) and 6 months (post-treatment) following discharge. The primary aim is to assess the feasibility and acceptability of CLASP-S. The secondary aim is to estimate the effects of CLASP-S on reducing suicidal thoughts and behaviors relative to ETAU.

Conditions

Schizophrenia; Suicide

Keywords

psychiatric hospitalization; suicide prevention; psychosis; psychosocial intervention

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire

  The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.

  6 months

Secondary Outcomes (1)

• Columbia Suicide Severity Rating Scale

  6 months

Study Arms (2)

Enhanced Treatment as Usual

ACTIVE COMPARATOR

Participants assigned to Enhanced Treatment as Usual (ETAU) alone will receive unrestricted routine care in the community. Assessment feedback reports will be sent to participants' community providers at baseline, 3 months, and 6 months for care coordination.

Behavioral: Enhanced Treatment as Usual

Coping Long-term with Active Suicide Program for Schizophrenia

EXPERIMENTAL

Coping Long-term with Active Suicide Program for Schizophrenia-Spectrum Disorders (CLASP-S) includes 3 individual sessions, 1 family meeting, and 11 phone sessions with the participant and their significant other over 6 months post-hospital discharge.

Behavioral: Enhanced Treatment as Usual; Behavioral: Coping Long-term with Active Suicide Program for Schizophrenia

Interventions

Enhanced Treatment as Usual BEHAVIORAL

Routine community care plus assessment feedback reports to clinicians.

Coping Long-term with Active Suicide Program for Schizophrenia; Enhanced Treatment as Usual

Coping Long-term with Active Suicide Program for Schizophrenia BEHAVIORAL

Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.

Coping Long-term with Active Suicide Program for Schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suicidal thoughts or behaviors prior to hospital admission
• diagnosis of a schizophrenia-spectrum disorder
• receiving pharmacotherapy
• years or older
• speaks/reads English

You may not qualify if:

• psychosis due to substance use or medical condition
• lack of phone access
• discharge to long-term facility

Sponsors & Collaborators

• Butler Hospital: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Schizophrenia; Suicide; Suicide Prevention; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Brandon Gaudiano, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)