跳至主要内容
临床试验/NCT03029468
NCT03029468已完成不适用

A Three-arm Feasibility Study of Web- and Smartphone-delivered Cognitive Behavioral Therapy as an Adjunct to Opioid Pain Treatment Among Adults With Sickle Cell Disease (SCD)

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Acceptability of cognitive behavioral therapy trial for participants

研究概览

简要总结

The primary aim of this study is to test the feasibility and acceptability of implementing a multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40 SCD patients with chronic pain and/or on chronic opioid pain treatment and randomize them 3:1 to two groups (cCBT and e-Education respectively), randomizing unevenly in order to best gather feasibility data for the cCBT. Both groups will use a mobile app to track daily pain/mood. The cCBT group will receive sessions of the CALM-SCD program to complete via mobile device and will have weekly follow-up with a care coach. The Education group will receive online education modules to complete via mobile device and will also have weekly follow-up with a care coach. The primary outcomes of the trial include feasibility (recruitment, retention, provider and patient feedback) and acceptability (sessions completed) of the CALM-SCD program.

详细描述

The objective of this study is to provide the experiences and data that will support a later, larger, and adequately powered effectiveness trial of the CALM-SCD, computerized cognitive behavioral therapy (cCBT) program. The investigators hypothesize that CALM-SCD is acceptable, i.e., patients will use it (90% of users will complete the first lesson within 3 months; 70% will complete³4 sessions; 50% of users will complete all 8 sessions), and feasible, i.e., the investigators can recruit >80% of patients approached, and >90% of enrolled participants will complete their 6-month follow-up assessment. The investigators will also have preliminary data on effectiveness and hypothesize that 70% of cCBT users will achieve a >50% decline in daily pain ratings.

The investigators will enroll 40 SCD patients at the University of Pittsburgh Medical Center (UPMC) with chronic pain to either CALM-SCD or pain education (eEducation) and follow them for 12 months. Implementation of routine stress/pain screening in the UPMC Adult Sickle Cell Clinic allows investigators to identify patients with SCD who have chronic pain as indicated by self-report "I have had pain nearly every day for at least 3 months" or have been prescribed long-acting opioids for pain.

Following confirmation of protocol-eligibility and informed consent, investigators will provide all patients with a large-screen smartphone (unless the patient owns their own compatible large-screen smartphone) with a symptoms diary app, and GPS tracking features pre-installed; this will allow investigators to track pain and mood as well as any opioid or non-opioid pain treatments used by patients, and steps traveled.

Patients enrolled in the CALM-SCD group will complete at least 4 1-hour cCBT sessions over 3 months using their personal or study-provided smartphone. Because cCBT programs are less effective without a human support component, participants will also be introduced to a care coach (master's level student tech who will receive training in CBT) who will contact them on a weekly basis by phone/text for up to 3 months. The care coach will reinforce CBT materials and encourage engagement. Participants will have continued access to the program after first 3 months, but care coach support will only be available on an as-needed basis.

Patients enrolled in the eEducation group will receive pain education through online modules that they will be asked to complete using their study-provided smartphone. Each module includes learning tasks, a reading assignment, and a short quiz based on material. The education group will receive care coach contact on the same schedule as the cCBT group. The care coach will provide supportive therapy and encouragement to complete modules and apply the lessons to their daily life.

研究设计

研究类型
Interventional
分配方式
Randomized
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

入选标准

  • To be eligible for the study, patients must be 18 years of age or older, have a documented diagnosis of SCD (HgbSS, HgbSC, SB+Thal, or SBoThal), receive routine care at the UPMC Sickle Cell Clinic, and self-report chronic pain or have been prescribed long-acting opioids for pain.

排除标准

  • Unable to provide informed consent due to low literacy or cognitive difficulties

结局指标

主要结局

Acceptability of cognitive behavioral therapy trial for participants

时间窗: 6 months

Number of cCBT sessions completed

Feasibility of recruitment and enrollment into cognitive behavioral therapy trial

时间窗: 3-6 months of open enrollment

Number of patients enrolled / number of patients screened and approached

次要结局

  • Pain interference(1, 3, 6, and 12 months)
  • Depressive symptoms(1, 3, 6, and 12 months)
  • Anxiety symptoms(1, 3, 6, and 12 months)
  • Pain Catastrophizing Scale(1, 3, 6, and 12 months)
  • Sickle Cell Self-efficacy Scale(1, 3, 6, and 12 months)
  • ASCQ-Me(1, 3, 6, and 12 months)
  • Pain intensity(1, 3, 6, and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Jonassaint

PhD

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验

Computerized Cognitive Behavioral Therapy Assisted... | 临床试验