Pilot RCT of a Video-based Intervention for Suicide Prevention

NCT05127330 | Completed Results DMC

• 1 other identifier: 1504431
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicidal Ideation; Suicidal Behaviors; Suicide

Keywords

Psychiatric Hospitalization

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire (CSQ)

  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 Outcomes (1)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  1 Month

Study Arms (2)

LifePlans

EXPERIMENTAL

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.

Behavioral: LifePlans

Treatment as Usual

ACTIVE COMPARATOR

Individuals will receive unrestricted routine care only.

Behavioral: Treatment as Usual

Interventions

LifePlans BEHAVIORAL

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.

LifePlans

Treatment as Usual BEHAVIORAL

Individuals will receive unrestricted routine mental health care in the community as appropriate for their condition.

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• current psychotic symptoms
• current cognitive impairment

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

This is a treatment development study and therefore was not designed to test the efficacy of the intervention given the small sample size. Instead, the goal was to examine feasibility and acceptability.

Results Point of Contact

• Title: Brandon Gaudiano, Ph.D.
• Organization: Butler Hospital

bgaudiano@butler.org

401-455-6457

Study Officials

• Brandon Gaudiano, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Lisa Uebelacker, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 19, 2021
• Study Start: January 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after the completion of the study and stored permanently.
• Access Criteria: Refer to NIMH Data Archive for details.

Locations

US (1)