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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04221269
Other study ID # 1908-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date June 1, 2023

Study information

Verified date July 2023
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Butler Hospital American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Columbia Suicide Severity Rating Scale 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. 6 months
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