Supplementing Brief Psychotherapy With a Mobile App

Emotion Regulation Clinical Trial

Official title:

Supplementing Brief Psychotherapy With a Mobile App

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867316
• Other study ID #: Pro2022001944
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: September 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Kleiman Lab Research Staff
• Phone: 8484452345
• Email: kleiman-lab[@]psych.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotion Regulation
• Self-Injurious Behavior
• Suicide
• Suicide and Self-harm

Intervention

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

Locations

Country	Name	City	State
United States	Rutgers University Behavioral Healthcare	Piscataway	New Jersey

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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