NCT06555094

Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App

Supplementing Brief Psychotherapy With a Mobile App

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.

Detailed description

This study is a companion project to NCT05848089. The present study is a two-arm parallel design RCT to test the efficacy of using ecological momentary intervention (EMI) to deliver therapeutic content based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) - an evidence-based transdiagnostic cognitive behavioral therapy (CBT) that focuses on delivering adaptive skills for managing strong emotions. Participants in this study will be 50 adult psychiatric inpatients with recent suicidal thoughts or behaviors (STBs). Participants will be randomized to receive either the control condition, which consists of treatment as usual (TAU; n = 25) and 4x/daily daily ecological momentary assessment (EMA) of emotions and STBs, or the experimental condition, consisting of TAU, 4x/daily EMA, 3 brief sessions to deliver CBT skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors, all drawn from the UP), and EMI to prompt guided skills practice (n = 25). Control participants will receive TAU and be prompted to complete 4x/day EMA of emotions and STBs for the duration of their hospital stay and the 28-day post-discharge period. Participants randomized to the experimental conditions will receive TAU plus three brief treatment sessions delivering core UP skills content (during inpatient stays) that may be offered after discharge via either phone or telehealth. Those in the experimental condition will also receive training to use the EMI (which prompts guided skills practice), followed by smartphone-based for the 28-day post-discharge period.

Conditions

• Suicidal Ideation
• Suicide
• Suicide Attempt

Interventions

Type	Name	Description
BEHAVIORAL	Ecological momentary assessment (EMA)	4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs
BEHAVIORAL	Treatment as usual (TAU)	TAU (or usual care) during hospitalization and the 28-day post-discharge period
BEHAVIORAL	Brief skills sessions plus EMI skills practice prompts	(1) Three brief treatment sessions delivering core cognitive behavioral therapy (CBT) skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors) (during hospitalization), (2) a discretionary booster session to reinforce treatment session content (that may be offered after discharge via either phone or telehealth), and (3) ecological momentary intervention (EMI) prompts to engage in guided skills practice exercises via smartphone

Timeline

• Start date: 2024-05-14
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: United States