Supplementing Brief Psychotherapy With a Mobile App

NCT ID: NCT05867316

Last Updated: 2025-06-13

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2024-06-06

Brief Summary

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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

Detailed Description

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Conditions

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Suicide and Self-harm Emotion Regulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unified Protocol

Unified Protocol-based treatment, with three sessions

Group Type EXPERIMENTAL

Unified Protocol

Intervention Type BEHAVIORAL

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

Interventions

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Unified Protocol

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

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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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Evan M. Kleiman, Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evan Kleiman

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Rutgers University Behavioral Healthcare

Piscataway, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R34MH113757

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2022001944

Identifier Type: -

Identifier Source: org_study_id

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