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Pilot RCT of a Video-based Intervention for Suicide Prevention

Pilot RCT of a Video-based Intervention for Suicide Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05127330
Enrollment
40
Registered
2021-11-19
Start date
2022-01-01
Completion date
2023-11-30
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Behaviors, Suicidal Ideation, Suicide

Keywords

Psychiatric Hospitalization

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.

Detailed description

In this project, we propose to develop a new intervention, called LifePlans. LifePlans will consist of brief videos that highlight patients' experiences. Episodes will cover these topics: 1) developing a personalized Life Plan to stay safe and restrict means, 2) clarifying valued life domains and related goals to improve hopefulness, 3) using informal problem solving to cope better with illness, 4) improving communication with family/friends to increase social support, and 5) adhering to primary treatments including pharmacotherapy and psychotherapy to promote illness management. 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.

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. Other mental health treatment is unrestricted.

BEHAVIORALTreatment as Usual

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

Sponsors

Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Client Satisfaction Questionnaire (CSQ)1 MonthThe 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

MeasureTime frameDescription
Columbia Suicide Severity Rating Scale (C-SSRS)1 MonthThe 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.

Countries

United States

Participant flow

Pre-assignment details

A total of 92 participants were approached for the study, and 40 were consented and enrolled in the study after it was determined that they met eligibility criteria.

Participants by arm

ArmCount
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.
19
Treatment as Usual
Individuals will receive unrestricted routine care only.
21
Total40

Baseline characteristics

CharacteristicTreatment as UsualTotalLifePlans
Age, Continuous40.0 years
STANDARD_DEVIATION 15.9
36.7 years
STANDARD_DEVIATION 14.7
33.0 years
STANDARD_DEVIATION 12.8
Columbia Suicide Severity Rating Scale (C-SSRS)13.6 score on scale
STANDARD_DEVIATION 2.7
14.0 score on scale
STANDARD_DEVIATION 2.7
14.5 score on scale
STANDARD_DEVIATION 2.6
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants36 Participants17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants0 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants34 Participants18 Participants
Region of Enrollment
United States
21 Participants40 Participants19 Participants
Sex: Female, Male
Female
8 Participants14 Participants6 Participants
Sex: Female, Male
Male
13 Participants26 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 14
other
Total, other adverse events
0 / 100 / 14
serious
Total, serious adverse events
1 / 100 / 14

Outcome results

Primary

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

Population: Difference due to missing data.

ArmMeasureValue (MEAN)Dispersion
LifePlansClient Satisfaction Questionnaire (CSQ)25.6 score on scaleStandard Deviation 3.1
Treatment as UsualClient Satisfaction Questionnaire (CSQ)24.6 score on scaleStandard Deviation 14
Secondary

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

Population: Difference due to missing data.

ArmMeasureValue (MEAN)Dispersion
LifePlansColumbia Suicide Severity Rating Scale (C-SSRS)7.6 score on scaleStandard Deviation 6.9
Treatment as UsualColumbia Suicide Severity Rating Scale (C-SSRS)6.1 score on scaleStandard Deviation 5.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026