EMDR to reduce pain interference in children with sickle cell disease
Effect of EMDR for Reduction of Pain Interference in Children With Sickle Cell Disease
This will test EMDR therapy to see if it reduces how much pain gets in the way of daily life for children and adolescents (6–18) with sickle cell disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07001631 on ClinicalTrials.gov |
What this trial studies
This single-center randomized controlled trial at Amsterdam UMC will enroll children and adolescents (6–18) with sickle cell disease who have elevated PROMIS pain interference scores and randomize them to immediate EMDR therapy or a waiting-list control. The intervention consists of an intake and up to six weekly one-hour EMDR sessions, while the control group waits nine weeks before receiving the same therapy. Outcomes include change in pain interference as the primary endpoint, with secondary measures of PTSD symptoms, anxiety, depression, physical complaints, pain frequency/severity, medication use, and school absence, measured at baseline and at standardized post-treatment timepoints. Feasibility and trauma-related memory themes will also be explored.
Who should consider this trial
Good fit: Children and adolescents aged 6–18 with a medical diagnosis of sickle cell disease, elevated PROMIS pain interference scores, and sufficient Dutch or English to complete assessments are the ideal candidates.
Not a fit: Patients who have had a successful stem cell transplant, are pregnant, have active severe psychiatric or unsafe living situations, are receiving concurrent trauma therapy, or have an estimated IQ below 80 may be excluded or unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, EMDR could reduce how much pain disrupts daily activities and school for children with sickle cell disease.
How similar studies have performed: EMDR is an established treatment for PTSD and has reduced pain in some adult studies, but its use specifically for reducing pain interference in children with sickle cell disease is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medical diagnosis of SCD * Age between 6 and 18 years old * Elevated pain interference scores: Reporting above the clinical cut-off T-score of 49 on PROMIS Pain Interference (parent-proxy version for children from 6-7 years and self-report version for children from 8 years). * Having sufficient knowledge of the Dutch or English languages to complete the assessments Exclusion Criteria: * Undergone successful stem cell transplantation * Pregnant adolescents * Current unsafety that is likely to interfere with psychological therapy for example ongoing domestic violence * Major interfering acute medical or psychiatric condition, such as psychosis, substance dependence, current severe self-harm or high risk for suicide requiring immediate treatment * Receiving psychological (trauma) treatment by another therapist at the same time * IQ estimated to be \< 80 based on information contained in the medical history or information from educational services/school
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Karin Fijnvandraat, prof. dr. — Amsterdam UMC
- Study coordinator: Mariana Nery, MD
- Email: m.c.nery@amsterdamumc.nl
- Phone: +31 020 - 5666462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.