Use of Facilitated STAIR Coach in Kenya

Not Applicable

Not yet recruiting

• Conditions: Facilatated STAIR Coach
• Interventions: Behavioral: STAIR Coach

• Registration Number: NCT06476457
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Study Start: 2024-12-01
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Facilitated STAIR Coach	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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