Expired Study
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Hartford, Connecticut 06106


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

13-032


NCT ID:

NCT02511769


Secondary ID:


Study Acronym:

Web-MAP


Brief Title:

Web-MAP Intervention for Youth With Sickle Cell Disease


Official Title:

WEB MAP Intervention for Youth With Sickle Cell Disease


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

11 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Connecticut Children's Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

42


Enrollment Type:

Actual


Overall Contact Information

Official Name:William T Zempsky, MD, MPH
Principal Investigator
Connecticut Children's Medical Center

Study Dates

Start Date:September 2013
Completion Date:August 18, 2016
Completion Type:Actual
Primary Completion Date:August 18, 2016
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 30, 2017
First Received Date:September 25, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Efficacy of reducing depressive symptoms
Time Frame:6 months
Safety Issues:False
Description:We will compare changes changes in depressive symptoms using the Centers for Epidemiological Study Depression scale from baseline to T2 (immediately after finishing the treatment arm) and T3 (6 months after enrollment in study). We will used a paired samp
Outcome Type:Primary Outcome
Measure:Efficacy in pain reduction
Time Frame:6 months
Safety Issues:False
Description:We will compare pain intensity (pain scores), pain burden (Sickle Cell Pain Burden Interview), activity limitations (Child Activity Limitations Interview), quality of life (PedsQL), and health service use, and their corresponding changes from baseline to

Study Interventions

Intervention Type:Behavioral
Name:WEB-MAP Educational Control Group
Description: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 educ
Arm Name:WEB-MAP Educational Control Group
Intervention Type:Behavioral
Name:WEB-MAP CBT
Description: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 co
Arm Name:WEB-MAP CBT

Study Arms

Study Arm Type:Active Comparator
Arm Name:WEB-MAP Educational Control Group
Description: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 educ
Study Arm Type:Experimental
Arm Name:WEB-MAP CBT
Description: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 co

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Connecticut Children's Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:Seattle Children's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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