Cognitive Behavioral Therapy and Real-Time Pain Managemen... | NCT04419168

ID	Type	Description	Link
CER-2018C2-13320 20	Other Grant/Funding Number	PCORI

Description Module

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

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
cCBT	Other	A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.	cCBT

Measure	Description	Time Frame
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

Measure	Description	Time Frame
6-month Change in Daily Pain Intensity	At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.	Baseline and 6 months

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinous-Chicago		Chicago	Illinois	60607	United States
Johns Hopkins

PubMed Identifier	Type	Citation	Retractions
40763347	Derived	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.
38171495	Derived

ID	Title	Description
FG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 15, 2020	Aug 19, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

95% Confidence Interval

T-score

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Units	Counts
Participants	OG000181 OG001178

Title

Denominators

Categories

Title	Measurements
	OG000-2.13(-3.42 to -0.84) OG001-2.66(-3.97 to -1.36)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		.57		Mean Difference (Final Values)	.54			2-Sided	95	-1.30	2.37					Superiority

Secondary

6-month Change in Daily Pain Intensity

At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Analysis population consisted of randomization participants with sufficient pain diary data over the 2 week period after each visit.

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

6-month Change in Patient Health Questionnaire (PHQ)

PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.

Analysis population consisted of randomization participants with PHQ2>0.

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

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

GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.

Analysis population consisted of randomization participants with GAD2>0.

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

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

The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.

Posted

Mean

95% Confidence Interval

T-score

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

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

The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 6 Months

Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.

Posted

Mean

95% Confidence Interval

percentage of total body area shaded

Baseline and 6 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

12-month Change in PROMIS Pain Interference

Posted

Mean

95% Confidence Interval

T-score

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

12-month Change in Daily Pain Intensity

Analysis population consisted of randomization participants with sufficient pain diary data over the 2 week period after each visit.

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

12-month Change in Patient Health Questionnaire (PHQ)

PHQ-9 for Clinic participants and PHQ-8 for Virtual participants with baseline PHQ-2 >0

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

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

GAD-7 for all participants with baseline GAD-2 >0

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

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

Posted

Mean

95% Confidence Interval

T-score

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

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

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

12-month Change in Current Opioid Misuse Measure (COMM)

Current Opioid Misuse Measure (COMM) is a self-reported measure to monitor indicators of current aberrant drug-related behaviors in patients with chronic pain on opioid therapy. Total scores are summed across the 9 individual items and range from 0-36, with higher scores representing greater misuse.

Posted

Mean

95% Confidence Interval

score on a scale

Baseline and 12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 12 Months

Posted

Mean

95% Confidence Interval

percentage of total body area shaded

12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

Number of Opioid Prescriptions

For patients recruited at one of the six clinical sites, study team will evaluate objectively measured opioid medication prescriptions and refills. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.

Analysis population consisted of randomization participants with available data from PCORnet.

Posted

Number

95% Confidence Interval

Prescriptions per person-year

12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

Number of Emergency Department Visits

For patients recruited at one of the six clinical sites, study team will evaluate objectively measured emergency department visits. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.

Analysis population consisted of randomization participants with available data from PCORnet.

Posted

Number

95% Confidence Interval

ED visits per person-year

12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Secondary

Number of Hospitalizations

For patients recruited at one of the six clinical sites, study team will evaluate objectively measured hospitalizations. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.

Analysis population consisted of randomization participants with available data from PCORnet.

Posted

Number

95% Confidence Interval

Hospitalizations per person-year

12 months

ID	Title	Description
OG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
OG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
General disorders and administration site conditions	General disorders	CTCAE	Systematic Assessment		EG0003 events3 affected181 at risk EG0010 events0 affected178 at risk
Cardiac Arrest	Cardiac disorders	CTCAE	Systematic Assessment		EG0000 events0 affected181 at risk EG0011 events1 affected178 at risk

ID	Term
D059350	Chronic Pain
D003863	Depression
D001008	Anxiety Disorders
D000755	Anemia, Sickle Cell
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006453	Hemoglobinopathies
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Title	Description
BG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
BG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. cCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.	3	181	3	181	0	181
EG001	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. m-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.	1	178	1	178	0	178