Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555094
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Supplementing Brief Psychotherapy With a Mobile App
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 4xdaily daily ecological momentary assessment EMA of emotions and STBs or the experimental condition consisting of TAU 4xdaily 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 4xday 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
Control participants will receive TAU and be prompted to complete 4xday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None