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

NCT03029468 | Completed

• 2 other identifiers: PRO17010378K23HL135396
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Chronic Pain

Keywords

Cognitive behavioral therapy; Chronic pain; Sickle cell disease; Mobile phone app; Mental health; Behavioral intervention; Behavioral health

Outcome Measures

Primary Outcomes (2)

• Acceptability of cognitive behavioral therapy trial for participants

  Number of cCBT sessions completed

  6 months

• Feasibility of recruitment and enrollment into cognitive behavioral therapy trial

  Number of patients enrolled / number of patients screened and approached

  3-6 months of open enrollment

Secondary Outcomes (7)

• Pain intensity

  1, 3, 6, and 12 months

• Pain interference

  1, 3, 6, and 12 months

• Depressive symptoms

  1, 3, 6, and 12 months

• Anxiety symptoms

  1, 3, 6, and 12 months

• Pain Catastrophizing Scale

  1, 3, 6, and 12 months

Other Outcomes (1)

• Activity space

  6 months

Study Arms (3)

Computerized CBT

EXPERIMENTAL

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

e-Education

ACTIVE COMPARATOR

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.

Behavioral: eEducation

Usual Care

NO INTERVENTION

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.

Interventions

cognitive behavioral therapy BEHAVIORAL

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.

Computerized CBT

eEducation BEHAVIORAL

Pain and sickle cell disease education delivered through a mobile electronic device

e-Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide informed consent due to low literacy or cognitive difficulties

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Toronto: collaborator
• University of Washington: collaborator
• Duke University: collaborator
• Vanderbilt University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Chronic Pain; Psychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Charles Jonassaint, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Three-arm feasibility trial

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: March 28, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)