Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT06476457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Facilitated STAIR Coach in Kenya
Sponsor:
Harvard Medical School (HMS and HSDM)
Organization:
Study Overview
Official Title:
Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific aim of this project is to examine the feasibility of using a low cost, low intensity, mobile app-based intervention teaching emotion regulation and interpersonal skills to improve general well-being for those with probable post-traumatic stress disorder (PTSD) in Kenyan clinics.
Detailed Description:
The aim of the present study is to examine the feasibility of the use of the Skills Training in Affective and Interpersonal Regulation (STAIR; Cloitre et al., 2020) Coach mobile app delivered through a mobile app for individuals with probable post-traumatic stress disorder (PTSD) in Kenya. This pilot study will recruit a total of 10 participants with probable PTSD. Participants will complete 10 modules focused on learning skills to improve interpersonal functioning and emotion regulation. The sessions will be facilitated by a mental health worker trained in STAIR. Participants will complete baseline (week 0), mid-treatmnet (week 5), post-treatment (week 11), one-month (week 15) and 3-month (week 23) follow-up visits.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: