Use of Facilitated STAIR Coach in Kenya

Harvard Medical School (HMS and HSDM)

Status: Not yet enrolling

Conditions: Facilatated STAIR Coach

Treatments: Behavioral: STAIR Coach

Study type: Interventional

Funder types: Other

Identifiers

NCT06476457

2024HSPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Facilitated STAIR Coach

Experimental group

Description:

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.

Treatment:

Behavioral: STAIR Coach