Low Cost, Low Intensity, Mobile-based Trauma Intervention (Facilitated STAIR Coach) for Use in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- PTSD Checklist for the DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
PTSD Checklist for the DSM-5 (PCL-5)
时间窗: 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)
时间窗: 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.
次要结局
- Patient Health Questionnaire (PHQ-9)(pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
研究者
Kristina Korte
Assistant Professor
Harvard Medical School (HMS and HSDM)