Pilot RCT of a Video-based Intervention for Suicide Prevention

March 26, 2024 updated by: Butler Hospital
The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in a pilot randomized controlled trial (n = 40) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • current psychiatric hospitalization for suicidal thoughts and behaviors
  • 18 years or older
  • ability to speak and read English
  • access to means for viewing videos (computer, tablet, smartphone)

Exclusion Criteria:

  • current psychotic symptoms
  • current cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LifePlans
LifePlans is a video series using real patients telling their stories of overcoming suicidal thoughts and behaviors to help others who are struggling with these issues.
LifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge. Other mental health treatment is unrestricted.
Active Comparator: Treatment as Usual
Individuals will receive unrestricted routine care only.
Individuals will receive unrestricted routine mental health care in the community as appropriate for their condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ)
Time Frame: 1 Month
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
1 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 1 Month
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.
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Lisa Uebelacker, PhD, Butler Hospital
  • Principal Investigator: Brandon Gaudiano, PhD, Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1504431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upload to NIMH Data Archive

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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