iCanCope With Sickle Cell Pain

Seattle Children's Healthcare System

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Behavioral: Education; Behavioral: Pain self-management

Study type: Interventional

Funder types: Other

Identifiers

NCT03201874

R01HD086978

Details and patient eligibility

About

The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.

Full description

Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.

Enrollment: 137 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 12-18 years
• diagnosed with any type of SCD
• able to speak and read English
• score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
• willing and able to complete online measures

Exclusion criteria

• significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
• have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 2 patient groups

Education Control

Active Comparator group

Description:

In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks.

Treatment:

Behavioral: Education

Pain Self-Management Intervention

Experimental group

Description:

In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks.

Treatment:

Behavioral: Education

Behavioral: Pain self-management