NCT04307394

Brief Summary

The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 24, 2023

Completed
Last Updated

March 24, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

March 11, 2020

Results QC Date

February 28, 2023

Last Update Submit

February 28, 2023

Conditions

Keywords

video interventiontreatment developmentopen trial

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 (1)

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

Interventions

LifePlansBEHAVIORAL

LifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge.

LifePlans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • plan to continue outpatient treatment
  • access to means for viewing videos (computer, tablet, smartphone)

You may not qualify if:

  • current psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

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

Study Officials

  • Brandon Gaudiano, PhD

    Butler Hospital

    PRINCIPAL INVESTIGATOR
  • Lisa Uebelacker, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

July 29, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 24, 2023

Results First Posted

March 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Upload to NIMH Data Archive

Time Frame
Plan to upload by 7/1/2023

Locations