Telehealth-delivered Massed Imaginal Exposure for PTSD: Toward Increasing Access to Alternative, Evidence-based Treatment Schedules for Virtual Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of treatment completion and pre-mature dropout.
研究概览
简要总结
The purpose of this study is to establish the safety, feasibility, and acceptability of very brief imaginal exposure therapy for post-traumatic stress disorder (PTSD) delivered by telehealth over the course of six-daily 60-minute sessions within a 10-day window. All study visits occur remotely, by telehealth. You will be asked to complete a pre-treatment assessment involving a clinical interview, video-based measures of emotional and physical reactions, such as heart rate and breathing rate, and self-report questionnaires to measure the severity and impact of trauma-related symptoms. These assessments are completed again 1-week, and 1-month after completing treatment. The researchers propose that massed exposure-based therapy delivered via telehealth will advance telemental health treatment options and personalized care for Veterans with PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Ability to speak, read, and write English.
- •Diagnosis of PTSD based on CAPS-5 (> 3 mo. post-trauma).
- •Seeking treatment for PTSD at the Charleston VA.
- •Willingness and ability to engage in assessment and treatment visits through VVC, or another VA-approved telehealth videoconferencing platform.
排除标准
- •Currently receiving psychotherapy for another anxiety- or stress-related condition.
- •Current substance use disorder diagnosis with repeated abuse or dependence within 3 months of study entry and unwillingness to abstain for 24 hours prior to study visits.
- •Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMSC; see measures).
- •Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems; DMSC, and chart review; see measures).
- •Current, or history of bipolar I disorder
- •Current, or history of psychotic symptoms
- •Serious suicidal risk or a suicide attempt in the past year, as determined by self-report (PHQ-9) and clinical interview (C-SSRS; see measures).
- •Active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion (DMSC, and chart review; see measures)
结局指标
主要结局
Rate of treatment completion and pre-mature dropout.
时间窗: from pre-treatment to 1-month follow-up
Total percent of patients retained from initial patients.
PTSD symptom checklist
时间窗: from pre-treatment to 1-month follow-up
PCL-5: PTSD Symptom Checklist for DSM-5. Scores range from 0 to 80, with higher scores indicating greater PTSD severity and impairment.
Satisfaction with treatment - provider
时间窗: 1 week post-treatment
PETQ: Prolonged exposure therapist questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment.
Satisfaction with treatment - patient
时间窗: 1 week post-treatment
STTSR: Satisfaction with Therapy and Therapist Scale-Revised; scores range 0-60 with higher scores indicating higher satisfaction
Adverse events
时间窗: from admission to 1 month follow up
Potential adverse events will be assessed with a structured as well as open-ended interview daily during treatment and at follow up.
Satisfaction with telehealth - patient
时间窗: 1 week post-treatment
Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.
Satisfaction with telehealth - provider
时间窗: 1 week post-treatment
TTSQ-Provider: Technology Treatment Satisfaction Questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment
CAPS: Clinician-Administered PTSD Scale for DSM-5
时间窗: from pre-treatment to 1-month follow-up
Structured interview for DSM-5 PTSD severity and impairment; Scores range from 0 to 80 with higher scores indicating greater PTSD severity and impairment.
Number of sessions attended per patient
时间窗: from pre-treatment to 1-month follow-up
Number of telehealth therapy appointments attended per patient.
次要结局
- Facial emotional expressivity(Pre-treatment, 1-week post-treatment, and 1-month follow-up.)
- Remote photoplethysmography(Pre-treatment, 1-week post-treatment, and 1-month follow-up.)
- Vocal and linguistic emotional expressivity(Pre-treatment, 1-week post-treatment, and 1-month follow-up.)