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cCBT for Chronic Pain (CaRISMA Trial)
N/A
Waitlist Available
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 baseline and 12 months
Awards & highlights
CaRISMA Trial Summary
This trial is testing whether mobile phone-delivered computerized cognitive behavioral therapy (cCBT) is more effective than digital education (m-Education) in reducing chronic pain among adult patients with sickle cell disease (SCD). 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).
Who is the study for?
Adults with sickle cell disease experiencing chronic pain, who are English-speaking and can pass consent comprehension questions. It's for those who've had pain most days in the past 3 months or use daily opioids for pain management.Check my eligibility
What is being tested?
The trial is testing two mobile phone interventions: computerized cognitive behavioral therapy (cCBT) and digital education (m-Education). Participants will also track their pain, mood, medication usage, and engage with an online support group while continuing regular care.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like therapy and education via a mobile app, there are no direct medical side effects. However, participants may experience emotional discomfort when discussing painful experiences or using new coping strategies.
CaRISMA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 baseline and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month Change in PROMIS Pain interference
Secondary outcome measures
12-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)
12-month Change in Current Opioid Misuse Measure (COMM)
12-month Change in Daily pain intensity
+14 moreCaRISMA Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: m-EducationExperimental Treatment1 Intervention
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.
Group II: cCBTExperimental Treatment1 Intervention
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.
Group III: Convenience ComparisonActive Control1 Intervention
Not participating in the intervention. Participants will complete the baseline questionnaire battery only and the investigational team will abstract their medical record data for the 12-months before enrollment and 12-months post enrollment.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,341,991 Total Patients Enrolled
16 Trials studying Chronic Pain
128,666 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any form of sickle cell disease.Any person, male or female, aged 18 or older.You experience pain on most days for the last 3 months or longer, and/or you are taking opioids daily or for a long period to manage your pain.countries
There are a few English speaking countries in the world
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: m-Education
- Group 2: cCBT
- Group 3: Convenience Comparison
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for individuals to join this research endeavor?
"Clinicaltrials.gov certifies that this clinical trial is still looking for individuals to participate in the study, which was initially posted on August 12th 2020 and revised April 26th 2022."
Answered by AI
What is the enrolment capacity of this research trial?
"This clinical trial requires 350 participants who meet the eligibility criteria to participate. There are two sites that patients can enrol at, Ohio State University in Columbus and University of Illinous-Chicago in Chicago respectively."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
North Carolina
What site did they apply to?
University of Illinous-Chicago
Johns Hopkins
Duke University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
How responsive is this trial?
Most responsive sites:
- Duke University: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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