Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications (CaRISMA)

  • STATUS
    Recruiting
  • End date
    Aug 11, 2024
  • participants needed
    350
  • sponsor
    University of Pittsburgh
Updated on 11 May 2022
analgesics
analgesia
opioid
behavior therapy
chronic pain
cognitive therapy
cognitive behavioral therapy
pain relieving

Summary

The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.

Description

The study interventions are both Internet-delivered, evidence-based tools that have been tailored specifically for the target population through a user-centered approach that has engaged stakeholders at each stage of the process.

  1. Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach 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. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.
  2. Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.

Details
Condition Chronic Pain, Depression, Anxiety, Opioid Use
Treatment cCBT, m-Education
Clinical Study IdentifierNCT04419168
SponsorUniversity of Pittsburgh
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

People with any type of sickle cell disease
Male or female, age 18 years or older
Reports chronic pain: i.e pain more days that not for the past 3 months or longer and/or is prescribed daily or long-acting opioids for pain
English speaking

Exclusion Criteria

Any potential participants who fail consent comprehension questions
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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