Clinical trial NCT02511769: Web-MAP Intervention for Youth With Sickle Cell Disease
Official title: WEB MAP Intervention for Youth With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2015-07-30
Enrollment: 42
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment from sickle cell centers will also be determined. The short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral intervention in a large population of youth with SCD. The long-term goal of this research is to develop effective, easily accessible, behavioral pain interventions for youth with SCD to reduce the long-term impact of pain on function, quality of life, and health service use in this population.

The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1) Subjects will be randomized to either the behavioral intervention or the online patient education control group. The treatment protocol will be implemented over 8 weeks in Internet-based treatment modules. The primary study outcome is pain and functional impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.

Detailed description: The proposed study will determine whether the efficacy of WebMAP generalizes to pediatric SCD, and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment from sickle cell centers will also be determined. The short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral intervention in a large population of youth with SCD. The long-term goal of this research is to develop effective, easily accessible, behavioral pain interventions for youth with SCD to reduce the long-term impact of pain on function, quality of life, and health service use in this population.

The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1) Subjects will be randomized to either the behavioral intervention or the online patient education control group. The treatment protocol will be implemented over 8 weeks in Internet-based treatment modules. The primary study outcome is pain and functional impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Documented sickle cell disease (verified by physician at SCD center if referred participant is a self referral)
* 11-18 years old
* Parental/patient consent and patient assent
* Internet and computer or smartphone access
* Score of \>3 on the SCPBI-Y

Exclusion Criteria:

* Primary language spoken other than English
* 11\<Age≤19
* Serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)
* More than 4 sessions of outpatient behavioral therapy for pain management in the 6 months prior to the time of screening

Primary outcomes:
measure: Efficacy in pain reduction
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of reducing depressive symptoms
timeFrame: 6 months
Other outcomes:
measure: Feasibility of WEB-MAP program
timeFrame: 6 months
Locations:
city: Hartford
country: United States
facility: CCMC
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: William T Zempsky, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: