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CompletedNCT04307394Updated Mar 24, 2023Results posted

Development of a Video-based Intervention for Suicide Prevention

An interventional study of LifePlans in Suicide and Psychiatric Hospitalization, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Suicide
  • Psychiatric Hospitalization

Keywords

  • video intervention
  • treatment development
  • open trial
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 10 is below the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • current psychotic symptoms
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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.

    Behavioral: LifePlans

Interventions

  • BehavioralLifePlans

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

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What researchers measure

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.

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

07

Results

Posted Mar 24, 2023
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.

Participant flow

Participant flow — Overall Study
MilestoneLifePlans
Started10
Completed5
Not completed5
Withdrew: Lost to follow-up3
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryClient 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.

Time frame:
1 month
Reported as:
Mean · score on a scale
Client Satisfaction Questionnaire (CSQ)
score on a scaleLifePlans
Client Satisfaction Questionnaire (CSQ)25.00 ± 5.83
SecondaryColumbia 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.

Time frame:
1 month
Reported as:
Mean · score on a scale
Columbia Suicide Severity Rating Scale (C-SSRS)
score on a scaleLifePlans
Baseline13.80 ± 2.39
Month 113.60 ± 7.67
Statistical analysis
  • LifePlans · t-test, 2 sided · p = 0.957

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LifePlans0/10 (0%)4/10 (40%)0/10 (0%)
Most frequent serious events
Most frequent serious events
EventLifePlans
Re-hospitalizationPsychiatric disorders4/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)LifePlans
Mean41.00 ± 15.67
Sex/Gender, Customized
Sex/Gender, Customized(Participants)LifePlans
Gender — Female6
Gender — Male1
Gender — Trans-female1
Gender — Trans-male1
Gender — More than one gender1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)LifePlans
Hispanic or Latino1
Not Hispanic or Latino9
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LifePlans
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White7
More than one race1
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(Participants)LifePlans
United States10
08

Study locations

1 site
  • Butler Hospital
    Providence, Rhode Island 02906, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 28, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Upload to NIMH Data Archive

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04307394
Lead sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Mar 13, 2020
Start date
Jul 29, 2021
Primary completion
May 1, 2022
Completion
May 1, 2022
Results posted
Mar 24, 2023
Last update
Mar 24, 2023

Study contacts

Brandon Gaudiano, PhD
principal investigator · Butler Hospital
Lisa Uebelacker, Ph.D.
principal investigator · Butler Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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