Supplementing Brief Psychotherapy With a Mobile App

NCT05867316 | Completed DMC

• 2 other identifiers: Pro2022001944R34MH113757
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. Most traditional treatments are not designed to be effective during a suicide crisis. In order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. As such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide

Conditions

Suicide and Self-harm; Emotion Regulation

Keywords

suicidal ideation; suicide attempts

Outcome Measures

Primary Outcomes (2)

• Suicidal thoughts

  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

  Overall changes in momentary self-reported intensity of suicidal urges (on a 11-point scale up to 4x/ day via ecological momentary assessment) from pre- to post-EMI use, across the study period, which is approximately four weeks post discharge

• Self-efficacy for managing negative emotion

  Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing negative emotions scale. The scale is measured with four five-point scale items, summed to a score ranging from 4 to 20 where higher scores are better.

  Beginning of study and end-of-study, approximately four weeks post discharge

Study Arms (1)

Unified Protocol

EXPERIMENTAL

Unified Protocol-based treatment, with three sessions

Behavioral: Unified Protocol

Interventions

Unified Protocol BEHAVIORAL

Unified Protocol based treatment, modified for use in brief treatment on inpatient units

Unified Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult status (18+ years)
• Admission to eligible units in our partner hospital with a reason for admission having to do with suicide risk
• 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)

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Massachusetts General Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Rutgers University Behavioral Healthcare

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior; Emotional Regulation; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Evan Kleiman

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 19, 2023
• Study Start: September 14, 2023
• Primary Completion: May 7, 2024
• Study Completion: June 6, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Code will be shared within three months after manuscript publication.

Locations

US (1)