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NCT04419168Completed

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

Source: ClinicalTrials.gov · Last updated 19 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
359 (actual)
First submitted
28 May 2020
Start date
12 Aug 2020
Primary completion date
31 May 2023
Lead sponsor
University of Pittsburgh
NCT number
NCT04419168

What you commit to

  • Study type: Interventional
  • Participants enrolled: 359
  • From 12 Aug 2020 to the primary completion date, 31 May 2023
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Any potential participants who fail consent comprehension questions

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Illinous-Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
East Carolina University
Coordinator of this site? Confirm its status
GreenvilleUnited StatesUnknown status
Vanderbilt University
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
University of Pittsburgh
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.