- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842667
Development and Preliminary Testing of a "Papageno"-Story Interview Intervention- Aim 3
April 20, 2026 updated by: Jane Harness, University of Michigan
The purpose of this study is to determine the effects of a short "Papageno story" video of a compilation of interviews on proximal risk factors for suicide.
The researchers believe that the intervention may increase protective factors related to suicide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Update 4/20/2026: We changed the study design section from "randomized" to "non-randomized" to reflect a change that was brought to our attention.
The platform we used for this study did not use a randomizing function, but rather, individuals were presented with surveys on their dashboards.
They only became aware of the surveys' content once they clicked the link and began the session.
They were not allowed to respond to both the "Papageno" and the active control surveys.
Study Type
Interventional
Enrollment (Actual)
506
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- People who are part of an existing cohort within DesignXM
- They will also answer yes to the question: "In the past 1 year, have you wished you were dead or wished you could go to sleep and not wake up?"
Exclusion Criteria:
- No exclusions if all inclusion criteria is met
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Papageno video
The arm will watch a compilation of interviews on proximal risk factors for suicide
|
The intervention will be a video (14 min 13 sec in length) of a series of clips from the "Papageno" interviews developed during the pilot phase of this project.
The decision to combine the videos and shorten the total length of the video was based on the feedback we received during the acceptability and feasibility phase of this study.
Interviewees were asked questions about a time in their life when they came close to suicide but found non-suicide alternatives (their "Papageno" story).
|
|
Active Comparator: Control video
The arm will watch an educational control video
|
The control condition will involve viewing a mental health education video (12 min 14 sec in length) created by our team.
It is a simple informational video, aimed at psychoeducation about suicide and safety promotion.
It includes a list of mental health and crisis resources.
Both videos are interview-style.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal ideation
Time Frame: Immediately before and after watching the video and at 3 months
|
Assessed with the Abbreviated Reasons For Living- Young Adult Abbreviated (RFL-YA-II) which consists of 24 questions rated on a scale of 1-6.
Higher scores indicate greater importance.
|
Immediately before and after watching the video and at 3 months
|
|
Hopelessness
Time Frame: Immediately before and after watching the video and at 3 months
|
Assessed with the Beck Hopelessness Scale-4 (BHS-4).
The BHS-4 assesses participants' sense of hopelessness, including perceptions of whether their personal actions can improve future outcomes.
Participants rate 4 items using a 4 point Likert scale (e.g.
"My future seems dark to me").
Each question is coded 0 for positive expectations and 1 for negative expectations.
|
Immediately before and after watching the video and at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant perceived agency
Time Frame: Immediately before and after watching the video and at 3 months
|
As measured by the Perceived Control Scale which is a single-item measure of participant perceived control.
Participants will rate agreement with the statement, "right now, I feel like things are out of my control" from 0-10 ("not at all" to "a lot").
|
Immediately before and after watching the video and at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jane Harness, DO, University of Michigan
- Principal Investigator: Cheryl King, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2025
Primary Completion (Actual)
October 6, 2025
Study Completion (Actual)
October 6, 2025
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 18, 2025
First Posted (Actual)
February 24, 2025
Study Record Updates
Last Update Posted (Actual)
April 23, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00266531
- SRG-1-123-19 (Other Grant/Funding Number: American Foundation for Suicide Prevention)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data that underlie the results reported.
IPD Sharing Time Frame
Approximately 5 years following publication.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by the investigator.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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