Computerized Cognitive Behavioral Therapy Assisted Life Management for Pain in Sickle Cell Disease (CALM-SCD)
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|ClinicalTrials.gov Identifier: NCT03029468|
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : October 8, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Chronic Pain||Behavioral: cognitive behavioral therapy Behavioral: eEducation||Not Applicable|
The objective of this study is to provide the experiences and data that will support a later, larger, and adequately powered effectiveness trial of the CALM-SCD, computerized cognitive behavioral therapy (cCBT) program. The investigators hypothesize that CALM-SCD is acceptable, i.e., patients will use it (90% of users will complete the first lesson within 3 months; 70% will complete³4 sessions; 50% of users will complete all 8 sessions), and feasible, i.e., the investigators can recruit >80% of patients approached, and >90% of enrolled participants will complete their 6-month follow-up assessment. The investigators will also have preliminary data on effectiveness and hypothesize that 70% of cCBT users will achieve a >50% decline in daily pain ratings.
The investigators will enroll 40 SCD patients at the University of Pittsburgh Medical Center (UPMC) with chronic pain to either CALM-SCD or pain education (eEducation) and follow them for 12 months. Implementation of routine stress/pain screening in the UPMC Adult Sickle Cell Clinic allows investigators to identify patients with SCD who have chronic pain as indicated by self-report "I have had pain nearly every day for at least 3 months" or have been prescribed long-acting opioids for pain.
Following confirmation of protocol-eligibility and informed consent, investigators will provide all patients with a large-screen smartphone (unless the patient owns their own compatible large-screen smartphone) with a symptoms diary app, and GPS tracking features pre-installed; this will allow investigators to track pain and mood as well as any opioid or non-opioid pain treatments used by patients, and steps traveled.
Patients enrolled in the CALM-SCD group will complete at least 4 1-hour cCBT sessions over 3 months using their personal or study-provided smartphone. Because cCBT programs are less effective without a human support component, participants will also be introduced to a care coach (master's level student tech who will receive training in CBT) who will contact them on a weekly basis by phone/text for up to 3 months. The care coach will reinforce CBT materials and encourage engagement. Participants will have continued access to the program after first 3 months, but care coach support will only be available on an as-needed basis.
Patients enrolled in the eEducation group will receive pain education through online modules that they will be asked to complete using their study-provided smartphone. Each module includes learning tasks, a reading assignment, and a short quiz based on material. The education group will receive care coach contact on the same schedule as the cCBT group. The care coach will provide supportive therapy and encouragement to complete modules and apply the lessons to their daily life.
Patients who are not eligible or who are not randomized into one of the intervention arms of this study will serve as a comparison group to ensure we are treating a representative sample of patients. Further, patients who were eligible but were not randomized into one of the intervention arms will serve as a usual care control group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Three-arm feasibility trial|
|Masking:||None (Open Label)|
|Official Title:||A Three-arm Feasibility Study of Web- and Smartphone-delivered Cognitive Behavioral Therapy as an Adjunct to Opioid Pain Treatment Among Adults With Sickle Cell Disease (SCD)|
|Actual Study Start Date :||March 28, 2018|
|Actual Primary Completion Date :||September 1, 2020|
|Actual Study Completion Date :||September 1, 2020|
Experimental: Computerized CBT
Computerized cognitive behavioral therapy (cCBT) for pain via an integrated smartphone and web-based skills training program: The training plan will help users learn 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; thus, the program involves regular homework assignments, and follow-up with the care coach and social network about issues faced and what skills were or could be used. 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.
Behavioral: cognitive behavioral therapy
CBT teaches 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.
Active Comparator: e-Education
Participants will receive pain education through online modules that they will be asked to complete using their personal or study-provided smartphone. Each module includes learning tasks, a reading assignment, and a short quiz based on material. The education group will receive care coach contact on the same schedule as the cCBT group. The care coach will provide supportive therapy and encouragement to complete modules and apply the lessons to their daily life.
Pain and sickle cell disease education delivered through a mobile electronic device
No Intervention: Usual Care
Participants who are not eligible or who are not randomized into one of the intervention arms of this study will serve as a comparison group to ensure we are treating a representative sample of patients. Further, patients who were eligible but were not randomized into one of the intervention arms will serve as a usual care control group.
- Acceptability of cognitive behavioral therapy trial for participants [ Time Frame: 6 months ]Number of cCBT sessions completed
- Feasibility of recruitment and enrollment into cognitive behavioral therapy trial [ Time Frame: 3-6 months of open enrollment ]Number of patients enrolled / number of patients screened and approached
- Pain intensity [ Time Frame: 1, 3, 6, and 12 months ]Average change in 0-10 VAS pain intensity over course of study
- Pain interference [ Time Frame: 1, 3, 6, and 12 months ]PROMIS Pain Interference
- Depressive symptoms [ Time Frame: 1, 3, 6, and 12 months ]PHQ-9 depression measure
- Anxiety symptoms [ Time Frame: 1, 3, 6, and 12 months ]GAD-7 anxiety scale
- Pain Catastrophizing Scale [ Time Frame: 1, 3, 6, and 12 months ]Pain Catastrophizing
- Sickle Cell Self-efficacy Scale [ Time Frame: 1, 3, 6, and 12 months ]Self-efficacy
- ASCQ-Me [ Time Frame: 1, 3, 6, and 12 months ]Quality of life measures
- Activity space [ Time Frame: 6 months ]GPS activity tracking on the smartphone
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- To be eligible for the study, patients must be 18 years of age or older, have a documented diagnosis of SCD (HgbSS, HgbSC, SB+Thal, or SBoThal), receive routine care at the UPMC Sickle Cell Clinic, and self-report chronic pain or have been prescribed long-acting opioids for pain.
- Unable to provide informed consent due to low literacy or cognitive difficulties
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): NCT03029468
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15237|
|Principal Investigator:||Charles Jonassaint, PhD||University of Pittsburgh|
|Responsible Party:||Charles Jonassaint, PhD, University of Pittsburgh|
|Other Study ID Numbers:||
K23HL135396 ( U.S. NIH Grant/Contract )
|First Posted:||January 24, 2017 Key Record Dates|
|Last Update Posted:||October 8, 2020|
|Last Verified:||October 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
A public-use data set (PUD) will be available through our study website. The PUD will be a cleaned, de-identified copy that includes all enrolled participants. Sensitive, identifying, unreliable, or invalid data will be excluded.
Researchers may request a copy of the PUD electronically from the Clinical Research Services at the University of Pittsburgh, conditional upon receiving IRB approval for a research proposal from their home institution.
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cognitive behavioral therapy
Sickle cell disease
Mobile phone app
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn