Supplementing Brief Psychotherapy With a Mobile App

Study Overview
=================
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

Official Title
-----------------
Supplementing Brief Psychotherapy With a Mobile App

Conditions
-----------------
Suicide and Self-harm, Emotion Regulation

Intervention / Treatment
-----------------
* Behavioral: Unified Protocol


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol<br>Unified Protocol-based treatment, with three sessions | Behavioral: Unified Protocol<br>* Unified Protocol based treatment, modified for use in brief treatment on inpatient units<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suicidal ideation, suicide attempts