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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02227472 -
Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
|
||
| Recruiting |
NCT06301893 -
Uganda Sickle Surveillance Study (US-3)
|
||
| Recruiting |
NCT04398628 -
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
|
||
| Completed |
NCT02522104 -
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
|
Phase 4 | |
| Recruiting |
NCT04688411 -
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
|
N/A | |
| Terminated |
NCT03615924 -
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
|
Phase 3 | |
| Not yet recruiting |
NCT06300723 -
Clinical Study of BRL-101 in Severe SCD
|
N/A | |
| Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
| Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
| Completed |
NCT04917783 -
Health Literacy - Neurocognitive Screening in Pediatric SCD
|
N/A | |
| Completed |
NCT02580565 -
Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
|
||
| Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
| Completed |
NCT04388241 -
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
|
N/A | |
| Recruiting |
NCT05431088 -
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
|
Phase 2/Phase 3 | |
| Completed |
NCT01158794 -
Genes Influencing Iron Overload State
|
||
| Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
| Withdrawn |
NCT02960503 -
Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02565082 -
Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
|
N/A | |
| Completed |
NCT02567682 -
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02620488 -
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
|
N/A |