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

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

Interventions

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

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Duke University

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Charles Jonassaint, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-28

Primary Completion

2020-09-01

Completion

2020-09-01

Countries

• United States

Study Locations