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A Single-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) (NCT03029468)

University of Washington
Duke University
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 or on chronic opioid pain treatment to receive 8 sessions of cCBT through our Web- and smartphone-based iCanCope with SCD program and weekly follow-up with a care coach. Participants will also use the iCanCope smartphone app to track daily pain intensity, pain interference and mood. The primary outcomes of the trial include feasibility (recruitment, retention, provider and patient feedback) and acceptability (sessions completed) of the iCanCope SCD program.
  • Behavioral: cognitive behavioral therapy
    CBT teaches users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • Unable to provide informed consent due to low literacy or cognitive difficulties
    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 iCanCope SCD, computerized cognitive behavioral therapy (cCBT) program. The investigators hypothesize that iCanCope 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 or on opioid therapy for chronic pain into the iCanCope SCD program and follow them for 12 months. While the investigators have already implemented routine stress/pain screening in the UPMC Adult Sickle Cell Clinic, the investigators will utilized EpicCare "best practice alerts" (BPA) that enable physicians to efficiently refer their patients to studies at the time of the patient encounter in response to an automated electronic alert. The investigators will utilize both methods 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 (BPA).

    Following confirmation of protocol-eligibility and informed consent, participating patients are provided with a large-screen smartphone with the iCanCope smartphone app that includes symptoms self-monitoring and our GPS tracking features pre-installed; this will allow tracking of pain and mood as well as any opioid or non-opioid pain treatments used by patients, and steps traveled. Patients enrolled in iCanCope will complete eight 1-hour cCBT sessions over 3 months using their 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 tech who has been trained in CBT) who will contact the participant on a weekly basis by phone/text and as needed for up to 3 months. The care coach will reinforce CBT materials and encourage engagement. Participants will have continued access to the program after 3 months, but without care coach support.

    1 locations

    United States (1)
    • University of Pittsburgh
      Not specified
      Pittsburgh, Pennsylvania, United States, 15237
    not yet recruiting
    31 August, 2017
    23 January, 2017
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