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Use of Facilitated STAIR Coach in Kenya

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06476457
Enrollment
10
Registered
2024-06-26
Start date
2024-12-01
Completion date
2025-12-31
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facilatated STAIR Coach

Keywords

STAIR, STAIR Coach, post-traumatic stress disorder

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.

Interventions

BEHAVIORALSTAIR 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.

Sponsors

Aga Khan University
CollaboratorOTHER
Harvard Medical School (HMS and HSDM)
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

We will recruit 10 participants to assess the feasibility of using STAIR Coach mobile based app for PTSD in Kenya

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for the DSM-5 (PCL-5)pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-upThe 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-upThe PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms.

Secondary

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

Contacts

Primary ContactKristina Korte, PhD
kkorte@mgh.harvard.edu6176436090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026