Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT06476457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Facilitated STAIR Coach in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'We will recruit 10 participants to assess the feasibility of using STAIR Coach mobile based app for PTSD in Kenya'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist for the DSM-5 (PCL-5)', 'timeFrame': 'pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up', 'description': 'The PCL is an 18-item measure assessing symptions of post-trauamatic stress disorder. Higher scores indicate higher levels of trauma related symptoms.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up', 'description': 'The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up', 'description': 'The PHQ-9 is a 9-item measure assessing symptoms of depression. Higher scores indicate greater levels of depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STAIR', 'STAIR Coach', 'post-traumatic stress disorder'], 'conditions': ['Facilatated STAIR Coach']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* criteria\n\n 1. 18 years of age or older\n 2. ability to complete the study in English\n 3. agreed to be contacted for follow-up studies when consenting to the parent study\n 4. not currently enrolled in another form of psychotherapy\n 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)\n 6. have a score of 33 or higher on the PCL-5 lifetime score in the parent study\n\n Exclusion Criteria:\n\n <!-- -->\n\n 1. less than 18 years of age\n 2. unable to complete the study in English\n 3. did not agree to be contacted for follow-up studies when consenting to the parent study\n 4. diagnosed with a psychotic disorder, unmedicated bipolar disorder, or severe substance-use disorder\n 5. experiencing ongoing long-term trauma as it is a contraindication for trauma focused treatment\n 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\n 7. participant is not competent to consent to the study as measured by the UBACC in the parent study\n 8. During parent study assessment (IRB23-0211), the participant receives a PCL score less than 33\n 9. Participant is receiving inpatient psychiatric care at the time of the study or experiencing involuntary detention'}, 'identificationModule': {'nctId': 'NCT06476457', 'briefTitle': 'Use of Facilitated STAIR Coach in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Harvard Medical School (HMS and HSDM)'}, 'officialTitle': 'Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya', 'orgStudyIdInfo': {'id': '2024HSPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facilitated STAIR Coach', '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.', 'interventionNames': ['Behavioral: STAIR Coach']}], 'interventions': [{'name': 'STAIR Coach', 'type': 'BEHAVIORAL', 'otherNames': ['STAIR', 'Skills Training in Affective and Interpersonal Regulation'], 'description': '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.', 'armGroupLabels': ['Facilitated STAIR Coach']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kristina Korte, PhD', 'role': 'CONTACT', 'email': 'kkorte@mgh.harvard.edu', 'phone': '6176436090'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aga Khan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kristina Korte', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}