Use of Facilitated STAIR Coach in Kenya

NCT ID: NCT06476457

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

Facilatated STAIR Coach

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Facilitated 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.

Group Type: EXPERIMENTAL

STAIR Coach

Intervention Type: BEHAVIORAL

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.

Interventions

STAIR 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

STAIR; Skills Training in Affective and Interpersonal Regulation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

Kristina Korte

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kristina Korte, PhD

Role: CONTACT

kkorte@mgh.harvard.edu

6176436090

Other Identifiers

2024HSPH

Identifier Type: -

Identifier Source: org_study_id