Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders

NCT ID: NCT04221269

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

Routine community care plus assessment feedback reports to clinicians.

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.

Group Type EXPERIMENTAL

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

Routine community care plus assessment feedback reports to clinicians.

Coping Long-term with Active Suicide Program for Schizophrenia

Intervention Type BEHAVIORAL

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

Interventions

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Enhanced Treatment as Usual

Routine community care plus assessment feedback reports to clinicians.

Intervention Type BEHAVIORAL

Coping Long-term with Active Suicide Program for Schizophrenia

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Foundation for Suicide Prevention

OTHER

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brandon Gaudiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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1908-001

Identifier Type: -

Identifier Source: org_study_id

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