Web-MAP Intervention for Youth With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

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.
    

Intervention name(s): WEB-MAP Educational Control Group; WEB-MAP CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): OPEC (Online Patient Education Control) Group: The purpose of the patient education control group is to control for time, attention, and computer usage. This group will serve as an attention control condition. Children will continue with the standard medical care that has been prescribed for their pain problem. Children and parents will be provided with access to a revised version of the Web-MAP study website, which will have two functional components: 1) information from publicly available educational websites about pediatric chronic pain management, 2) diary and assessments. This version of the website differs from the one accessed by the treatment condition in that it does not provide access to behavioral and cognitive skills training via treatment modules for children and parents.; Web-MAP Group: Participants will have access to the full version of the web program. They will be asked to log in to the website using their own personal computer at home, work, school, or a public library. Participants in the Web-MAP group will have access to treatment modules and daily diaries on the web site. The online treatment will take between 8 and 9 weeks for participants to complete. Children and parents will be asked to log onto the web site, read through the treatment modules, and complete practice assignments to learn new skills (e.g., relaxation). Adolescents and parents will be asked to complete a total of 8 modules each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment