Sickle Cell Disease Clinical Trial
Official title:
WEB MAP Intervention for Youth With Sickle Cell Disease
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.
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.
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