Development and Feasibility Testing of an Internet-based Pain Self-management Program for Persons With Acute Recurrent and Chronic Pancreatitis Pain (The IMPACT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Treatment acceptability
研究概览
简要总结
Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available medical treatments have limited efficacy. Pain self-management programs equip patients to minimize the impact of chronic painful conditions on activity, health, and psychosocial functioning. The purpose of the current study is to pilot the use of Internet-delivered pain self-management course in adults with chronic and acute recurrent pancreatitis to generate preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial.
详细描述
Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) are associated with high disease burden across the lifespan. Recurring abdominal pain is the most prevalent and distressing symptom. Pain severity reduces health-related quality of life for individuals with CP and is associated with increased fatigue, anxiety and depressive symptoms, lower general health status, and reduced physical and role functioning. Medical therapies for CP pain have limited efficacy. Cognitive-behavioral interventions (CBT) offer safe and effective alternatives to pharmacological treatments for pain management. In other chronic painful conditions including gastrointestinal disorders, CBT interventions have been effective for reducing pain and pain impact including disability and depressive symptoms. CBT is traditionally provided by trained psychologists working with individual patients one-on-one or in small groups. Access to CBT is limited by availability of providers, with long waiting lists at centers offering CBT. The Internet is an ideal medium to provide pain self-management interventions that are low-cost and sustainable, and internet-based CBT has shown efficacy in children and adults with chronic pain, allowing clinics to greatly extend their reach to patients. The purpose of this study is to test the acceptability, feasibility, and preliminary efficacy of an Internet-delivered CBT pain self-management course for adults with acute recurrent and chronic pancreatitis pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Able and willing to provide informed consent for participation in this study
- •Meet CPDPC criteria for diagnosis of either suspected CP (CPDPC "yellow zone") or definite CP (CPDPC "red zone")
- •Have personal internet access on any device (e.g., phone, tablet, computer)
- •Has experienced pain intensity rated as 4 or higher on a 0-10 scale in the last month
排除标准
- •Currently undergoing treatment for cancer
- •Inability to understand English well enough to complete questionnaires or to participate in treatment
- •Severe depression (i.e., indicated by a score > 22 on the Patient Health Questionnaire (PHQ-9)
- •Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9)
- •Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)
- •Currently receiving treatment with a psychologist
研究组 & 干预措施
Internet-based CBT intervention
In addition to standard medical care, participants in the Internet-based CBT group will receive access to the Pancreatitis Pain Course and will be asked to complete all online modules over 2 months using their own smartphone or computer. A coach will guide participants through the weekly lessons.
干预措施: Internet-based CBT intervention (Behavioral)
Wait list control group
Participants assigned to the Wait list control group will be asked to continue with any recommendations made by their clinic provider and will not be offered any internet-based content until after they complete the 5 month assessments (i.e. Months 5-7).
结局指标
主要结局
Treatment acceptability
时间窗: Immediately post-treatment
Participants will complete a 12-item Treatment Evaluation Inventory questionnaire that assesses satisfaction and acceptability of the course of treatment and satisfaction with the outcome of the intervention. Items are rated on a 5-point Likert scale ranging from 1 = Strongly disagree, to 5 = Strongly agree.
次要结局
- Treatment feasibility(Immediately post-treatment)
- Change in pain intensity(Baseline, 3-month follow-up)
- Change in Medication use(Baseline, 3-month follow-up)
- Change in pain-related disability(Baseline, 3-month follow-up)
- Change in Disease specific and generic health related quality of life (HRQOL)(Baseline, 3-month follow-up)
- Change in Pain self-efficacy(Baseline, 3-month follow-up)
- Change in Psychological distress(Baseline, 3-month follow-up)
- Change in Sleep and Fatigue(Baseline, 3-month follow-up)
研究者
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital
