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Supplementing Brief Psychotherapy With a Mobile App

Primary Purpose

Suicide and Self-harm, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide and Self-harm focused on measuring suicidal ideation, suicide attempts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers University Behavioral HealthcareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unified Protocol

Arm Description

Unified Protocol-based treatment, with three sessions

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
September 18, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Massachusetts General Hospital, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05867316
Brief Title
Supplementing Brief Psychotherapy With a Mobile App
Official Title
Supplementing Brief Psychotherapy With a Mobile App
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Massachusetts General Hospital, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm, Emotion Regulation
Keywords
suicidal ideation, suicide attempts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unified Protocol
Arm Type
Experimental
Arm Description
Unified Protocol-based treatment, with three sessions
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol
Intervention Description
Unified Protocol based treatment, modified for use in brief treatment on inpatient units
Primary Outcome Measure Information:
Title
Suicidal thoughts
Description
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
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
Title
Self-efficacy for managing negative emotion
Description
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.
Time Frame
Beginning of study and end-of-study, approximately four weeks post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kleiman Lab Research Staff
Phone
8484452345
Email
kleiman-lab@psych.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Bentley, PhD
Email
kbentley@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Kleiman
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University Behavioral Healthcare
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Kleiman
Email
evan.kleiman@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Evan Kleiman

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Code will be shared within three months after manuscript publication.
IPD Sharing URL
https://osf.io/6wctf/

Learn more about this trial

Supplementing Brief Psychotherapy With a Mobile App

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