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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419168
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Charles Jonassaint, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Depression, Anxiety Opioid Use Other: cCBT Other: m-Education Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparative effectiveness trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cCBT
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.
Other: cCBT
A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.

Experimental: m-Education
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.
Other: m-Education
A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

No Intervention: Convenience Comparison
Not participating in the intervention. Participants will complete the baseline questionnaire battery only and we will abstract their medical record data for the 12-months before enrollment and 12-months post enrollment.



Primary Outcome Measures :
  1. Change in Pain interference [ Time Frame: 3, 6, 12 months ]
    - PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale a validated questionnaire that assesses how day-to-day function is altered by pain. Range 8-40, higher scores may mean that pain limits your activity level and enjoyment of certain activities


Secondary Outcome Measures :
  1. Change in Daily pain intensity [ Time Frame: 3, 6, 12 months ]
    Daily pain intensity: 3, 6 and 12-month change in average daily pain intensity "Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419168


Contacts
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Contact: Charles Jonassaint, PhD 412-586-9850 cjonassaint@pitt.edu
Contact: Laura De Castro, MD 412-648-6575 decastrolm@upmc.edu

Locations
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United States, Illinois
University of Illinous-Chicago
Chicago, Illinois, United States, 60607
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
Contact: Patrick Carroll, MD         
Contact: Sophie Lanzkron, MD         
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27708
Contact: Nirmish Shah, MD         
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Contact: Payal Desai, MD         
Sponsors and Collaborators
University of Pittsburgh
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Responsible Party: Charles Jonassaint, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04419168    
Other Study ID Numbers: PRO20030015
CER-2018C2-13320 20 ( Other Grant/Funding Number: PCORI )
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charles Jonassaint, University of Pittsburgh:
sickle cell disease
pain
opioids
depression
cognitive behavioral therapy
mobile technology
digital health
mHealth
implementation science
community-based participatory research
Additional relevant MeSH terms:
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Chronic Pain
Depression
Behavioral Symptoms
Pain
Neurologic Manifestations
Signs and Symptoms