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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. 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.

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

Conditions
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Chronic Pain, Depression, Anxiety, Opioid Use

Intervention / Treatment
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* Other: cCBT
* Other: m-Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: comparative effectiveness trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cCBT<br>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<br>* A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.<br>|
| Experimental: m-Education<br>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<br>* A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.<br>|
| No Intervention: Convenience Comparison<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain interference | - 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 | 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily pain intensity | 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? | 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell disease, pain, opioids, depression, cognitive behavioral therapy, mobile technology, digital health, mHealth, implementation science, community-based participatory research