Clinical trial NCT04419168: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Official title: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative effectiveness trial
Primary purpose: TREATMENT

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.

Detailed description: CaRISMA is a randomized comparative effectiveness trial among adult patients with SCD who report chronic pain (N = 350) randomized to receive either cCBT (n = 175) or m-Education (n = 175). A third group of adult patients with SCD who do not meet the criteria for having chronic pain or who are not interested in participating in the intervention will be a convenience non-chronic pain comparison group and will not receive any intervention or scheduled follow-up. The non-chronic pain comparison group will only complete the battery of questionnaires at baseline and each time they return to the clinic for a medical visit. The study will access patients' stored information or verbally obtained information to assess a person's eligibility and suitability for potential participation in the study.

All adult patients, age 18 or above, with a self-report SCD diagnosis, are willing to complete a brief stress and pain functioning screener (stress/pain screener). The stress/pain screener includes measures of depression, anxiety, disability, pain (intensity, quality, and location), and quality of life. The PHQ-9 and GAD-7 measures are administered as part of routine clinical care at the UPMC comprehensive sickle cell clinic and will both be utilized as part of the stress and pain functioning screener for research purposes in the study. Each patient completes electronic versions of all or some of these scales before the sickle cell clinic social worker or psychologist sees them. The total screener typically takes patients about 15-20 minutes to complete.

Patients who do meet the criteria for having chronic pain will be randomized to one of the two intervention groups. For at least 12 weeks, one group will be asked to engage in a mobile cCBT program tailored for adults with SCD. The second group will receive pain and SCD education on mobile phones (m-Education). Both programs use identical mobile technology platforms; only the content differs. The cCBT program focuses on teaching behavioral coping skills through participants' "seeing and doing" while the pain education arm focuses on improving self-management through participants' "learning and knowing" more about pain and SCD. All participants in the intervention group will have weekly follow-ups with a health coach and will track pain symptoms daily during the intervention. A smartphone is required to participate in the intervention. If an interested and eligible participant does not have a smartphone, one may be provided to them. Upon completion of the study, the participant may keep the phone after completing all study elements, including having the study team remove all study-related data from the phone.

Both arms of the intervention will be delivered through pre-programmed chatbot interactions administered in a mobile messaging app. The intervention arm is automatically assigned via the chatbot. When the CaRISMA intervention is opened for the first time, it will automatically randomize each participant to either study arm: cCBT or m-Education. The participants will not know which arm they have been assigned to, and they will only have access to the materials included in the respective study arm

Participants will receive a link to our online survey tool where they will be asked to respond to a set of questionnaires and Painimation, a novel pain assessment tool.

The questionnaires are as follows: Sickle Cell Self-Efficacy Scale (SCSS), Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference, Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorders Scale (GAD- 7), and the Current Opioid Misuse Measure (COMM). For participants who are eligible to be randomized, in addition to baseline questionnaires, items from the Coping Strategies Questionnaire (CSQ) will be asked through the messaging app as participants progress through their respective programs.

The Painimation tool is an electronic pain assessment tool developed by our team at the University of Pittsburgh that allows users to better communicate their pain symptoms. Patients are provided with a selection of animations that they use to describe the quality of their pain. The animations can be increased or decreased in speed, color saturation, focus, and size, to reflect the intensity of their pain.

For intervention participants, in addition to the quantitative assessments, our partners at the Qualitative, Evaluation, And Stakeholder Engagement (Qual EASE) Research Services will conduct a set of qualitative interviews to further understand which intervention works best for whom and when, the lived experience of patients in the trial, and differences in perceptions between depression subgroups. Qual- EASE will randomly select 48 participants (of the 350) to be interviewed. Attending the qualitative interviews is completely voluntary and participants may opt out at any time. However, if one of the 48 selected participants does opt out, Qual-EASE will invite another participant, of those not previously selected, as a replacement.

In the first three months of the study, intervention participants will complete all modules of their assigned study arm (cCBT or m-Education) at their own pace. The recommended progression is one module per week; this will give participants time to practice the techniques taught in each module. Participants will be asked to complete a daily electronic diary to track their pain symptoms. Only intervention arm participants will receive follow-up assessment. The convenience comparison group will not be followed with scheduled assessments.

At the 3-month assessment (T1) (i.e., three months after enrollment, on the same date the participant began the study) participants will again receive a link to our online survey tool to complete the second iteration of Painimation, the SCSS, PROMIS, ASCQ-ME, PHQ-9 and GAD-7. If participants have questions while completing these questionnaires, they may contact their health coach for guidance.

Participants will also be asked to complete daily pain intensity entries in the electronic diary. If participants do not complete the questionnaires or the pain intensity entries, health coaches will contact them and remind them to do so. The 48 patients selected for qualitative interviews will have their second interview with Qual- EASE at this time.

Between months 4-6, participants will continue to use the CaRISMA intervention but will no longer have weekly follow-ups with a health coach except upon request or on an as-needed basis. At the end of month 6 (T2), they will receive a link to our online survey tool to complete Painimation, the SCSS, PROMIS, ASCQ-ME, PHQ-9, and GAD-7 for the third time. Participants will continue to complete daily pain intensity entries through the electronic diary.

Between months 6-12, participants will continue daily pain diary submissions and communication with health coaches only as desired. Additionally, Qual-EASE will conduct the final set of qualitative interviews with 48 of the 350 participants.

In the final month of the study (T3), participants will receive a link to our online survey tool to complete Painimation, the SCSS, PROMIS, ASCQ-ME, PHQ-9, GAD- 7 and COMM for the final time.

The pain diary may include some version of the following types of questions in daily assessments:

* 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?
* Did you take opiate medications today?
* Which one of the following emojis best represents your mood today? The pain diary may include some version of the following types of questions in weekly assessments:
* 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?
* Did you take opiate medications today?
* Compared to what you used yesterday, is the amount of opiate meds you took today less than yesterday, the same as yesterday, or more than yesterday?
* Did you take non-opiate medications today?
* This past week, how often have you been bothered by little interest or pleasure in doing things?
* This past week, how often have you been bothered by feeling down, depressed, or irritable?
* This past week, how often have you been bothered by feeling nervous, anxious, or on edge?
* This past week, how often have you been bothered by not being able to stop or control worry?

Medical Outcomes (PCORnet). For patients recruited at one of the five clinical sites, we will evaluate objectively measured opioid medication refills and emergency department visits or hospitalizations for pain crisis. We will be working in collaboration with PCORnet to collect data retrospectively (from the past 12 months) and prospectively (12 months from the date of enrollment) from patient medical records.

These data will allow us to track medications including opioid pain medication prescriptions and refills, and health care utilization (i.e., emergency department visits and hospitalizations), as well as lab values (e.g., hemoglobin level) and clinical outcomes (e.g., end-organ damage score). For the patients recruited from our community partner organizations or online who are not affiliated with a participating clinical center, we will only acquire or evaluate their medical records for the purpose of confirming their sickle cell diagnosis.

The primary outcome is the change in pain interference at 6 months. Secondary outcomes include changes in pain intensity, depression (PHQ), anxiety (GAD), quality of life (ASCQ-ME), self-efficacy (SCSES), opioid misuse (COMM), and health care utilization at 6 and 12 months. The study team has updated the outcomes to be more comprehensive due to the funder's requirement that it align with the contract milestones

Eligibility 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

Primary outcomes:
measure: 6-month Change in PROMIS Pain Interference
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: 6-month Change in Daily Pain Intensity
timeFrame: Baseline and 6 months
measure: 6-month Change in Patient Health Questionnaire (PHQ)
timeFrame: Baseline and 6 months
measure: 6-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: Baseline and 6 months
measure: 6-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)
timeFrame: Baseline and 6 months
measure: 6-month Change in Sickle Cell Self-Efficacy Scale (SCSES)
timeFrame: Baseline and 6 months
measure: Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 6 Months
timeFrame: Baseline and 6 months
measure: 12-month Change in PROMIS Pain Interference
timeFrame: Baseline and 12 months
measure: 12-month Change in Daily Pain Intensity
timeFrame: Baseline and 12 months
measure: 12-month Change in Patient Health Questionnaire (PHQ)
timeFrame: Baseline and 12 months
measure: 12-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: Baseline and 12 months
measure: 12-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)
timeFrame: Baseline and 12 months
measure: 12-month Change in Sickle Cell Self-Efficacy Scale (SCSES)
timeFrame: Baseline and 12 months
measure: 12-month Change in Current Opioid Misuse Measure (COMM)
timeFrame: Baseline and 12 months
measure: Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 12 Months
timeFrame: 12 months
measure: Number of Opioid Prescriptions
timeFrame: 12 months
measure: Number of Emergency Department Visits
timeFrame: 12 months
measure: Number of Hospitalizations
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinous-Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
citation: 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.