Computerized Cognitive Behavioral Therapy Assisted Life Management for Pain in Sickle Cell Disease



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain, Anemia
Therapuetic Areas:Hematology, Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:5/12/2018
Start Date:March 28, 2018
End Date:September 1, 2020
Contact:Charles Jonassaint, PhD
Email:cjonassaint@pitt.edu
Phone:412-586-9580

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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)

The primary aim of this study is to test the feasibility and acceptability of implementing a
multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain
symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40
SCD patients with chronic pain and/or on chronic opioid pain treatment and randomize them 3:1
to two groups (cCBT and e-Education respectively), randomizing unevenly in order to best
gather feasibility data for the cCBT. Both groups will use a mobile app to track daily
pain/mood. The cCBT group will receive sessions of the CALM-SCD program to complete via
mobile device and will have weekly follow-up with a care coach. The Education group will
receive online education modules to complete via mobile device and will also have weekly
follow-up with a care coach. The primary outcomes of the trial include feasibility
(recruitment, retention, provider and patient feedback) and acceptability (sessions
completed) of the CALM-SCD program.

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 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 from
Painaction.com. 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.

Partients 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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Unable to provide informed consent due to low literacy or cognitive difficulties
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Charles Jonassaint, PhD
Phone: 412-586-9850
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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