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
- Diseases
- Sickle cell disease
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Illinous-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.