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

Chronic Pain Clinical Trial

— CALM-SCD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029468
• Other study ID #: PRO17010378
• Secondary ID: K23HL135396
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Chronic Pain
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
University of Pittsburgh	Duke University, National Heart, Lung, and Blood Institute (NHLBI), University of Toronto, University of Washington, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity space	GPS activity tracking on the smartphone	6 months
Primary	Acceptability of cognitive behavioral therapy trial for participants	Number of cCBT sessions completed	6 months
Primary	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	Pain intensity	Average change in 0-10 VAS pain intensity over course of study	1, 3, 6, and 12 months
Secondary	Pain interference	PROMIS Pain Interference	1, 3, 6, and 12 months
Secondary	Depressive symptoms	PHQ-9 depression measure	1, 3, 6, and 12 months
Secondary	Anxiety symptoms	GAD-7 anxiety scale	1, 3, 6, and 12 months
Secondary	Pain Catastrophizing Scale	Pain Catastrophizing	1, 3, 6, and 12 months
Secondary	Sickle Cell Self-efficacy Scale	Self-efficacy	1, 3, 6, and 12 months
Secondary	ASCQ-Me	Quality of life measures	1, 3, 6, and 12 months