Use of Facilitated STAIR Coach in Kenya

Harvard Medical School (HMS and HSDM)10 enrolled

Overview

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.

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

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Facilatated STAIR Coach

Interventions

STAIR CoachBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Secondary Outcomes

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.

Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Central Contacts

Kristina Korte, PhD

CONTACT

6176436090 kkorte@mgh.harvard.edu

Data from ClinicalTrials.gov

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