Clinical trial NCT06476457: Use of Facilitated STAIR Coach in Kenya
Official title: Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Facilatated STAIR Coach
Keywords: STAIR
STAIR Coach
post-traumatic stress disorder
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Aga Khan University
First posted: 2024-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will recruit 10 participants to assess the feasibility of using STAIR Coach mobile based app for PTSD in Kenya
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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:

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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

Primary outcomes:
measure: PTSD Checklist for the DSM-5 (PCL-5)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Other outcomes:
Locations:
Study officials:
References: