Facilatated STAIR CoachNCT06476457
Use of Facilitated STAIR Coach in Kenya
A study testing STAIR Coach in people with Facilatated STAIR Coach, run by Harvard Medical School (HMS and HSDM).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facilatated STAIR Coach
- What is being tested?
- STAIR Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- criteria
- 18 years of age or older
- ability to complete the study in English
- agreed to be contacted for follow-up studies when consenting to the parent study
- not currently enrolled in another form of psychotherapy
- 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)
- have a score of 33 or higher on the PCL-5 lifetime score in the parent study
Who cannot join
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- less than 18 years of age
- unable to complete the study in English
- did not agree to be contacted for follow-up studies when consenting to the parent study
- diagnosed with a psychotic disorder, unmedicated bipolar disorder, or severe substance-use disorder
- experiencing ongoing long-term trauma as it is a contraindication for trauma focused treatment
Show all 10Show fewer
- experiencing acute levels of alcohol or is under the influence of an illegal substance, demonstrated by inpatient medical care for alcohol or substance abuse
- participant is not competent to consent to the study as measured by the UBACC in the parent study
- During parent study assessment (IRB23-0211), the participant receives a PCL score less than 33
- Participant is receiving inpatient psychiatric care at the time of the study or experiencing involuntary detention
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya
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.
Read the 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
- Being tested
- STAIR Coach
- Keywords
- STAIR, STAIR Coach, post-traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAIR CoachBehavioural
Also called STAIR, Skills Training in Affective and Interpersonal Regulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated STAIR Coach | Experimental | 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. Receives: Behavioral: STAIR Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Secondary outcomes (1)
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.
Measured: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facilatated STAIR CoachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will recruit 10 participants to assess the feasibility of using STAIR Coach mobile based app for PTSD in Kenya
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Kristina Korte, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476457
- Sponsor's protocol ID
- 2024HSPH
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya
- ClinicalTrials.gov ID
- NCT06476457
- Acronym / sponsor ID
- 2024HSPH
- Conditions
- Facilatated STAIR Coach
- Keywords
- STAIR, STAIR Coach, post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will recruit 10 participants to assess the feasibility of using STAIR Coach mobile based app for PTSD in Kenya
| Arm | Type | Receives |
|---|---|---|
| Facilitated STAIR Coach | Experimental | Behavioral: STAIR CoachSTAIR (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- criteria
Key exclusion criteria (10 listed)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAIR CoachAlso: STAIR, Skills Training in Affective and Interpersonal RegulationSTAIR 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. | Behavioural | Facilitated STAIR Coach |
Primary outcome
PTSD Checklist for the DSM-5 (PCL-5)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
The 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)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms.
1 secondary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing STAIR Coach in people with Facilatated STAIR Coach, run by Harvard Medical School (HMS and HSDM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Korte, PhD (6176436090, kkorte@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for the DSM-5 (PCL-5) (time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.