Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders

Overview

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.

Full Title of Study: “Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2021

Interventions

  • Behavioral: Enhanced Treatment as Usual
    • Routine community care plus assessment feedback reports to clinicians.
  • Behavioral: Coping Long-term with Active Suicide Program for Schizophrenia
    • Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.

Arms, Groups and Cohorts

  • Active Comparator: Enhanced Treatment as Usual
    • 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.
  • Experimental: Coping Long-term with Active Suicide Program for Schizophrenia
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Client Satisfaction Questionnaire
    • Time Frame: 6 months
    • 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.

Secondary Measures

  • Columbia Suicide Severity Rating Scale
    • Time Frame: 6 months
    • The Columbia Suicide Severity Rating Scale is an interviewer-rated measure of suicidal thoughts and behaviors. The total score (sum of items) will be used and ranges from 2 to 25 with higher scores indicating higher suicidal thoughts and behaviors.

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Butler Hospital
  • Collaborator
    • American Foundation for Suicide Prevention
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brandon Gaudiano, PhD, Principal Investigator, Butler Hospital
  • Overall Contact(s)
    • Cheryl Cordeira, 401-455-6654, CCordeiro@butler.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.