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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 : Recruiting
First Posted : January 24, 2017
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
University of Toronto
University of Washington
Duke University
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Charles Jonassaint, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Chronic Pain Behavioral: cognitive behavioral therapy Behavioral: eEducation Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Three-arm feasibility trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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 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.
Behavioral: eEducation
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.



Primary Outcome Measures :
  1. Acceptability [ Time Frame: 6 months ]
    Number of cCBT sessions completed

  2. Feasibility [ Time Frame: 3-6 months of open enrollment ]
    Number of patients enrolled / number of patients screened and approached


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 1, 3, 6, and 12 months ]
    Average change in 0-10 VAS pain intensity over course of study

  2. Pain interference [ Time Frame: 1, 3, 6, and 12 months ]
    PROMIS Pain Interference

  3. Depressive symptoms [ Time Frame: 1, 3, 6, and 12 months ]
    PHQ-9 depression measure

  4. Anxiety symptoms [ Time Frame: 1, 3, 6, and 12 months ]
    GAD-7 anxiety scale

  5. Pain Catastrophizing Scale [ Time Frame: 1, 3, 6, and 12 months ]
    Pain Catastrophizing

  6. Sickle Cell Self-efficacy Scale [ Time Frame: 1, 3, 6, and 12 months ]
    Self-efficacy

  7. ASCQ-Me [ Time Frame: 1, 3, 6, and 12 months ]
    Quality of life measures


Other Outcome Measures:
  1. Activity space [ Time Frame: 6 months ]
    GPS activity tracking on the smartphone



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Charles Jonassaint, PhD 412-586-9580 cjonassaint@pitt.edu
Contact: Jordan Driscoll, BA 412-623-1668 Jad166@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Charles R Jonassaint, PhD    412-586-9850    cjonassaint@pitt.edu   
Principal Investigator: Charles Jonassaint, PhD         
Sponsors and Collaborators
University of Pittsburgh
University of Toronto
University of Washington
Duke University
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Charles Jonassaint, PhD University of Pittsburgh

Responsible Party: Charles Jonassaint, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03029468     History of Changes
Other Study ID Numbers: PRO17010378
K23HL135396 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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

Keywords provided by Charles Jonassaint, University of Pittsburgh:
Cognitive behavioral therapy
Chronic pain
Sickle cell disease
Mobile phone app
Mental health
Behavioral intervention
Behavioral health

Additional relevant MeSH terms:
Chronic Pain
Anemia, Sickle Cell
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn