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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 : June 3, 2019
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

Tracking Information
First Submitted Date  ICMJE January 20, 2017
First Posted Date  ICMJE January 24, 2017
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE March 28, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Acceptability [ Time Frame: 6 months ]
    Number of cCBT sessions completed
  • Feasibility [ Time Frame: 3-6 months of open enrollment ]
    Number of patients enrolled / number of patients screened and approached
Change History Complete list of historical versions of study NCT03029468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Pain intensity [ Time Frame: 3 and 6 months ]
    Average change in 0-10 VAS pain intensity over course of study
  • Pain interference [ Time Frame: 3 and 6 months ]
    Brief pain inventory and PROMIS pain interference measures
  • Depressive symptoms [ Time Frame: 3 and 6 months ]
    PHQ-9 depression measure
  • Anxiety symptoms [ Time Frame: 3 and 6 months ]
    GAD-7 anxiety scale
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2017)
Activity space [ Time Frame: 6 months ]
GPS activity tracking on the smartphone
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Computerized Cognitive Behavioral Therapy Assisted Life Management for Pain in Sickle Cell Disease
Official Title  ICMJE 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)
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.
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Three-arm feasibility trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Chronic Pain
Intervention  ICMJE
  • 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.
  • Behavioral: eEducation
    Pain and sickle cell disease education delivered through a mobile electronic device
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: cognitive behavioral therapy
  • 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.
    Intervention: Behavioral: eEducation
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles Jonassaint, PhD 412-586-9580 cjonassaint@pitt.edu
Contact: Jordan Driscoll, BA 412-246-6009 Jad166@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03029468
Other Study ID Numbers  ICMJE PRO17010378
K23HL135396 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Charles Jonassaint, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • University of Toronto
  • University of Washington
  • Duke University
  • Vanderbilt University
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Charles Jonassaint, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP