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

NCT04419168 | Completed Results DMC

• 2 other identifiers: STUDY20110346CER-2018C2-13320 20
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Pain; Depression, Anxiety; Opioid Use

Keywords

sickle cell disease; pain; opioids; depression; cognitive behavioral therapy; mobile technology; digital health; mHealth; implementation science; community-based participatory research

Outcome Measures

Primary Outcomes (1)

• 6-month Change in PROMIS Pain Interference

  The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain.

  Baseline and 6 months

Secondary Outcomes (17)

• 6-month Change in Daily Pain Intensity

  Baseline and 6 months

• 6-month Change in Patient Health Questionnaire (PHQ)

  Baseline and 6 months

• 6-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)

  Baseline and 6 months

• 6-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)

  Baseline and 6 months

• 6-month Change in Sickle Cell Self-Efficacy Scale (SCSES)

  Baseline and 6 months

Study Arms (2)

cCBT

EXPERIMENTAL

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

m-Education

EXPERIMENTAL

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

Interventions

cCBT OTHER

A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.

cCBT

m-Education OTHER

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

m-Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any potential participants who fail consent comprehension questions

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (7)

University of Illinous-Chicago

Chicago, Illinois, 60607, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

Related Publications (3)

• Oluwole OB, McGill LS, Gayle K, O'Brien JA, Abebe KZ, Jonassaint CR, Hamm M. Experiences With a Multicomponent Digital Behavioral Pain Management Intervention for Adults With Sickle Cell Disease: Qualitative Analysis of the CaRISMA Trial. JMIR Hum Factors. 2025 Aug 5;12:e73719. doi: 10.2196/73719.

  PMID: 40763347 DERIVED

• Jonassaint CR, Parchuri E, O'Brien JA, Lalama CM, Lin J, Badawy SM, Hamm ME, Stinson J, Lalloo C, Carroll CP, Saraf SL, Gordeuk VR, Cronin R, Shah N, Lanzkron SM, Liles D, Trimnell C, Bailey L, Lawrence RH, Abebe KZ. Mental health, pain and likelihood of opioid misuse among adults with sickle cell disease. Br J Haematol. 2024 Mar;204(3):1029-1038. doi: 10.1111/bjh.19243. Epub 2024 Jan 3.

  PMID: 38171495 DERIVED

• Badawy SM, Abebe KZ, Reichman CA, Checo G, Hamm ME, Stinson J, Lalloo C, Carroll P, Saraf SL, Gordeuk VR, Desai P, Shah N, Liles D, Trimnell C, Jonassaint CR. Comparing the Effectiveness of Education Versus Digital Cognitive Behavioral Therapy for Adults With Sickle Cell Disease: Protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) Study. JMIR Res Protoc. 2021 May 14;10(5):e29014. doi: 10.2196/29014.

  PMID: 33988517 DERIVED

MeSH Terms

Conditions

Chronic Pain; Depression; Anxiety Disorders; Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Charles Jonassaint
• Organization: University of Pittsburgh

cjonassaint@pitt.edu

412-586-9850

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: comparative effectiveness trial

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 5, 2020
• Study Start: August 12, 2020
• Primary Completion: May 31, 2023
• Study Completion: December 11, 2023
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)