Web-MAP Intervention for Youth With Sickle Cell Disease

NCT ID: NCT02511769

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-08-18

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.

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WEB-MAP CBT

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.

Group Type: EXPERIMENTAL

WEB-MAP CBT

Intervention Type: BEHAVIORAL

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.

WEB-MAP Educational Control Group

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.

Group Type: ACTIVE_COMPARATOR

WEB-MAP Educational Control Group

Intervention Type: BEHAVIORAL

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.

Interventions

WEB-MAP Educational Control Group

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.

Intervention Type: BEHAVIORAL

WEB-MAP CBT

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

William Zempsky, MD

Head, Division of Pain and Palliative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William T Zempsky, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

CCMC

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

13-032

Identifier Type: -

Identifier Source: org_study_id