Pilot of an Integrated Treatment for Comorbid PTSD and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility Indicator: Number of Participants Screened
研究概览
简要总结
Posttraumatic stress disorder (PTSD) occurs in approximately 7% of adults in the general population. PTSD greatly impacts quality of life and often co-occurs with other conditions such as chronic pain. Individuals with co-morbid PTSD and chronic pain demonstrate higher PTSD symptoms and pain (as well as greater anxiety, depression, disability, and opioid use) compared to those with only one of those conditions. Gold standard treatments exist for both PTSD (e.g., Prolonged Exposure; PE) and chronic pain (e.g., Cognitive Behavioral Therapy for Chronic Pain; CBT-CP) and are generally offered sequentially (i.e., one at a time for the condition that is most prominent). Treating these conditions separately may overlook their interconnected nature, which may reduce efficacy and increase dropout. Thus, there is a need for an intervention to target both simultaneously, which may be more effective and efficient than treating conditions sequentially.
This is a single-arm pilot study to assess the feasibility and acceptability of an integrated treatment for adults with comorbid PTSD and chronic pain. The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment draws from modules in PE and CBT-CP including psychoeducation, exposure to feared/avoided situations and activities, processing of exposures, behavioral activation, breathing and relaxation techniques, sleep hygiene, symptom monitoring, and structured homework assignments. Baseline and post-treatment assessments will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •English-speaking
- •Currently meets criteria for PTSD, assessed by the CAPS-5 (any trauma type) - Chronic pain, assessed by greater than or equal to 4 on a scale of 0-10 pain severity over the past 3 months
- •Medically stable at the time of study enrollment (chronic illness and disability does not prevent attendance of outpatient therapy sessions)
- •Stable on psychotropic medication for past 60 days
- •Agreed to not change current medication or pain-related treatments over the course of the study unless medically necessary
排除标准
- •Lifetime diagnosis of schizophrenia, other psychotic disorder, or bipolar I disorder
- •Participation in concurrent evidence-based psychological treatment for PTSD or chronic pain during the past 3 months
- •Participants must not participate in an evidence-based psychological treatment for either PTSD or pain during the course of the study.
- •Moderate or severe substance use in the past 90 days
- •Cognitive impairment to the degree that the patient cannot provide informed consent or fill out assessment measures
- •Participants who in the PI's judgement pose a current homicidal or suicidal risk
研究组 & 干预措施
Integrated PTSD and Chronic Pain Treatment
Integrated treatment combining modules from Prolonged Exposure Therapy with Cognitive Behavioral Therapy for Chronic Pain
干预措施: Integrated Treatment for PTSD and Chronic Pain (Behavioral)
结局指标
主要结局
Feasibility Indicator: Number of Participants Screened
时间窗: Baseline
Feasibility assessment will include number of participants screened defined as number of individuals who complete our initial eligibility screener.
Feasibility Indicator: Enrollment
时间窗: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Number of Sessions Attended
时间窗: Post-Treatment Assessment at approximately 6 weeks
Feasibility assessment will include the number of sessions attended on average (out of 12).
Feasibility Indicator: Attrition Percentage
时间窗: Post-Treatment Assessment at approximately 6 weeks
A feasibility measure of attrition will be assessed by examining the percent of individuals who did not complete all 12 intervention sessions.
Feasibility Indicator: Number of Assessments Attended
时间窗: Baseline and Post-Treatment Assessment at approximately 6 weeks
A feasibility indicator of number of assessments (baseline and post-treatment) attended will be measured.
Feasibility Indicator: Percentage of Self-Reports Completed
时间窗: Baseline, Post-Intervention at approximately 6 weeks, Every Other Treatment Session (Every 2 weeks up to 12 weeks)
Self-reports are administered at each assessment (baseline and post-intervention) as well as every other treatment session (every 2 weeks up to 12 weeks). Therefore, there are 8 total self-report assessments and the percentage of those completed will be calculated.
Intervention Satisfaction
时间窗: Post-Treatment Assessment at approximately 6 weeks
Intervention satisfaction will be rated with a Likert scale ranging from 1-10 with greater scores indicating higher satisfaction.
Intervention Acceptability
时间窗: Post-Treatment Assessment at approximately 6 weeks
Intervention acceptability will be measured on a Likert scale ranging from 1-10 with greater scores indicating higher acceptability.
Qualitative Intervention Feedback
时间窗: Post-Treatment Assessment at approximately 6 weeks
Open-ended questions that include assessing overall impressions of treatment, feedback on the frequency and length of sessions, challenges or barriers, likelihood of recommending this treatment to a friend, and comparison of this treatment to other treatments received in the past.
次要结局
- Change in Score on the Clinician Administered PTSD Score (CAPS-5)(Baseline to approximately 6 weeks)
- Change in Score on the PTSD Checklist for DSM-5 (PCL-5)(Baseline to approximately 6 weeks)
- Change in Score on the Pain Severity Subscale of the Brief Pain Inventory (BPI)(Baseline to approximately 6 weeks)
- Change in Score on the Pain Interference Subscale of the Brief Pain Inventory (BPI)(Baseline to approximately 6 weeks)
- Change in Score on the Pain Catastrophizing Scale (PCS)(Baseline to approximately 6 weeks)
- Change in Score on the Chronic Pain Acceptance Questionnaire (CPAQ)(Baseline to approximately 6 weeks)
- Change in Score on the Posttraumatic Cognitions Inventory (PTCI)(Baseline to approximately 6 weeks)
- Change in Score on the Fear-Avoidance Components Scale (FACS)(Baseline to approximately 6 weeks)
- Change in Score on the Anxiety Sensitivity Index (ASI-3)(Baseline to approximately 6 weeks)
- Change in Score on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)(Baseline to approximately 6 weeks)
- Change in Score on the Expectancies for Alcohol Analgesia (EAA) Measure(Baseline to approximately 6 weeks)
- Change in Score on the Difficulties in Emotion Regulation Scale (DERS-18)(Baseline to approximately 6 weeks)
- Change in Score on the Patient Health Questionnaire (PHQ-9)(Baseline to approximately 6 weeks)
- Change in Score on the Insomnia Severity Index (ISI)(Baseline to approximately 6 weeks)
- Change in Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA-2)(Baseline to approximately 6 weeks)
- Change in Score on the Quality of Life Inventory (QOLI)(Baseline to approximately 6 weeks)