- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05848089
Real-time Intervention for Suicide Risk Reduction
Study Overview
Status
Conditions
Detailed Description
The present study is a two-arm parallel design RCT to test the efficacy of using ecological momentary intervention (EMI) to deliver therapeutic content based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) - an evidence-based transdiagnostic cognitive behavioral therapy (CBT) that focuses on delivering adaptive skills for managing strong emotions. Participants in this study will be 50 adult psychiatric inpatients with recent suicidal thoughts or behaviors (STBs). Participants will be randomized to receive either the control condition, which consists of treatment as usual (TAU; n = 25) and 4x/daily daily ecological momentary assessment (EMA) of emotions and STBs, or the experimental condition, consisting of TAU, 4x/daily EMA, 3 brief sessions to deliver CBT skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors, all drawn from the UP), one discretionary skills booster session, and EMI to prompt guided skills practice (n = 25).
Control participants will receive TAU and be prompted to complete 4x/day EMA of emotions and STBs for the duration of their hospital stay and the 28-day post-discharge period. Participants randomized to the experimental conditions will receive TAU plus three brief treatment sessions delivering core UP skills content (during inpatient stays) and a discretionary booster session to reinforce treatment sessions that may be offered after discharge via either phone or telehealth. Those in the experimental condition will also receive training to use the EMI (which prompts guided skills practice), followed by smartphone-based EMA/EMI for the duration of the inpatient stay and the 28-day post-discharge period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kate Bentley, PhD
- Phone Number: 617-724-7741
- Email: kbentley@mgh.harvard.edu
Study Contact Backup
- Name: Evan Kleiman, PhD
- Email: evan.kleiman@rutgers.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02130
- Recruiting
- Brigham and Women's Faulkner Hospital
-
Contact:
- Christopher AhnAllen, PhD
- Email: cahnallen@bwh.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult status (18+ years),
- a recent suicide attempt or any report of current suicidal ideation,
- the ability to speak and write English fluently,
- ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone), and
- providing at least one collateral contact in cases where we cannot reach the participant
Exclusion criteria:
- the presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Treatment as usual (TAU) + EMA
Participants will receive TAU and be prompted to complete 4x/day smartphone-based EMA surveys of negative emotion and STBs.
|
4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs
TAU (or usual care) during hospitalization and the 28-day post-discharge period
|
Experimental: Experimental intervention + TAU
Participants will receive TAU plus 3 brief sessions of CBT skills, one discretionary post-discharge skills booster session, and 4x/day EMA and prompted EMI, which guides in-the-moment CBT skills practice.
|
4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs
TAU (or usual care) during hospitalization and the 28-day post-discharge period
(1) Three brief treatment sessions delivering core cognitive behavioral therapy (CBT) skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors) (during hospitalization), (2) a discretionary booster session to reinforce treatment session content (that may be offered after discharge via either phone or telehealth), and (3) ecological momentary intervention (EMI) prompts to engage in guided skills practice exercises via smartphone
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Within-person changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment) from pre- to post-EMI
Time Frame: Through study completion (up to 28 days after inpatient hospital discharge)
|
Overall changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) from pre- to post-EMI use, among those in the experimental condition only
|
Through study completion (up to 28 days after inpatient hospital discharge)
|
Between-condition differences in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment)
Time Frame: Through study completion (up to 28 days after inpatient hospital discharge)
|
Means and slopes of momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) will be compared between the experimental and control conditions
|
Through study completion (up to 28 days after inpatient hospital discharge)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P000221
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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