Real-time Intervention for Suicide Risk Reduction

NCT ID: NCT05848089

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-02-19

Brief Summary

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The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.

Detailed Description

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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.

Conditions

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Suicidal Ideation Suicide Attempt

Keywords

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Suicide Suicidal Ideation Suicide Attempt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Ecological momentary assessment (EMA)

Intervention Type BEHAVIORAL

4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

TAU (or usual care) during hospitalization and the 28-day post-discharge period

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.

Group Type EXPERIMENTAL

Brief skills sessions plus EMI skills practice prompts

Intervention Type BEHAVIORAL

(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

Ecological momentary assessment (EMA)

Intervention Type BEHAVIORAL

4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

TAU (or usual care) during hospitalization and the 28-day post-discharge period

Interventions

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Brief skills sessions plus EMI skills practice prompts

(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

Intervention Type BEHAVIORAL

Ecological momentary assessment (EMA)

4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

TAU (or usual care) during hospitalization and the 28-day post-discharge period

Intervention Type BEHAVIORAL

Other Intervention Names

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cognitive behavioral therapy ecological momentary intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Adam C. Jaroszewski, PhD

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2023P000221

Identifier Type: -

Identifier Source: org_study_id