Back to resultsPilot RCT of a Video-based Intervention for Suicide Prevention
Primary Purpose
Suicidal Ideation, Suicidal Behaviors, Suicide
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LifePlans
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Psychiatric Hospitalization
Eligibility Criteria
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
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LifePlans
Treatment as Usual
Arm Description
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.
Individuals will receive unrestricted routine care only.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05127330
Brief Title
Pilot RCT of a Video-based Intervention for Suicide Prevention
Official Title
Pilot RCT of a Video-based Intervention for Suicide Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicidal Behaviors, Suicide
Keywords
Psychiatric Hospitalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LifePlans
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Individuals will receive unrestricted routine care only.
Intervention Type
Behavioral
Intervention Name(s)
LifePlans
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Individuals will receive unrestricted routine mental health care in the community as appropriate for their condition.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Uebelacker, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upload to NIMH Data Archive
Learn more about this trial
Pilot RCT of a Video-based Intervention for Suicide Prevention
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