Supplementing Brief Psychotherapy With a Mobile App

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

Study Overview

• Status: Recruiting
• Conditions: Emotion Regulation; Suicide and Self-harm
• Intervention / Treatment: Behavioral: Unified Protocol

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kleiman Lab Research Staff; Phone Number: 8484452345; Email: kleiman-lab@psych.rutgers.edu
• Study Contact Backup: Name: Kate Bentley, PhD; Email: kbentley@mgh.harvard.edu

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Recruiting
      • Rutgers University Behavioral HealthCare
      • Contact: Evan Kleiman; Email: evan.kleiman@rutgers.edu
      • Principal Investigator: Evan Kleiman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute of Mental Health (NIMH); Massachusetts General Hospital
• Investigators: Principal Investigator: Evan Kleiman, Rutgers, the State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: suicidal ideation; suicide attempts
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: Pro2022001944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No