Supplementing Brief Psychotherapy With a Mobile App

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05867316
Collaborator
Massachusetts General Hospital (Other), National Institute of Mental Health (NIMH) (NIH)
40
1
1
10
4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Unified Protocol
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Supplementing Brief Psychotherapy With a Mobile App
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Unified Protocol

Unified Protocol-based treatment, with three sessions

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

Outcome Measures

Primary Outcome Measures

  1. Suicidal thoughts [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]

    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

  2. Self-efficacy for managing negative emotion [Beginning of study and end-of-study, approximately four weeks post discharge]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers University Behavioral Healthcare Piscataway New Jersey United States 08854

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Evan Kleiman, Rutgers, The State University of New Jersey

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Evan M. Kleiman, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT05867316
Other Study ID Numbers:
  • Pro2022001944
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Evan M. Kleiman, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2023