Use of Facilitated STAIR Coach in Kenya

Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Facilatated STAIR Coach
• Intervention / Treatment: Behavioral: STAIR Coach

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina Korte, PhD; Phone Number: 6176436090; Email: kkorte@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• criteria

  1. 18 years of age or older
  2. ability to complete the study in English
  3. agreed to be contacted for follow-up studies when consenting to the parent study
  4. not currently enrolled in another form of psychotherapy
  5. if currently prescribed medications, participants must be on a stable dosage of psychotropic medications (i.e., prescribed on stable dose for 1 month or more)

  6. have a score of 33 or higher on the PCL-5 lifetime score in the parent study

     Exclusion Criteria:

  1. less than 18 years of age
  2. unable to complete the study in English
  3. did not agree to be contacted for follow-up studies when consenting to the parent study
  4. diagnosed with a psychotic disorder, unmedicated bipolar disorder, or severe substance-use disorder
  5. experiencing ongoing long-term trauma as it is a contraindication for trauma focused treatment
  6. experiencing acute levels of alcohol or is under the influence of an illegal substance, demonstrated by inpatient medical care for alcohol or substance abuse
  7. participant is not competent to consent to the study as measured by the UBACC in the parent study
  8. During parent study assessment (IRB23-0211), the participant receives a PCL score less than 33
  9. Participant is receiving inpatient psychiatric care at the time of the study or experiencing involuntary detention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facilitated STAIR Coach; STAIR (Skills Training in Affective and Interpersonal Regulation ) Coach is a brief, low-intensity mobile-based intervention targeting difficulties in affective and interpersonal regulation. STAIR Coach participants will complete 10 interventions modules. Every two week, the participant will meet with a facilitator to review the module materials.	Behavioral: STAIR Coach; STAIR is a brief, low-intensity intervention targeting difficulties in affective and interpersonal regulation that tend to be a significant problem for those exposed to traumatic events.; Other Names: Skills Training in Affective and Interpersonal Regulation; STAIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for the DSM-5 (PCL-5)	The PCL is an 18-item measure assessing symptions of post-trauamatic stress disorder. Higher scores indicate higher levels of trauma related symptoms.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborators: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: post-traumatic stress disorder; STAIR; STAIR Coach
• Other Study ID Numbers: 2024HSPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No