Effect of EMDR for Reduction of Pain Interference in Children With Sickle Cell Disease

NCT ID: NCT07001631

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2027-07-01

Brief Summary

Children with sickle cell disease may experience frequent painful episodes. This, together with the traumatic experiences during a hospitalization, can lead to the development of posttraumatic stress reactions. As the stress can trigger painful episodes (pain crisis) in children with sickle cell disease, the investigators think that treating these stress symptoms can reduce the pain-related problems in their lives. Eye Movement Desensitization and Reprocessing (EMDR) is proven to be an effective trauma treatment for posttraumatic stress disorder. Research studies show that EMDR can reduce pain in adults. The investigators want to study now if EMDR effective is in reducing pain-related problems in children with sickle cell disease.

Detailed Description

Objective: The primary objective of this study is to investigate the efficacy of EMDR therapy in reducing pain interference in the lives of children with SCD. Secondary objectives are to study the efficacy of EMDR in reducing PTSD symptoms, anxiety, depressive symptoms, physical complaints (low mobility), frequency and severity of pain, use of pain medication, and number of days absent from school. Themes of pain and trauma-related memories and feasibility of EMDR therapy for this population will also be explored.

Study design: In this single-center randomized controlled trial (RCT) patients (aged 6-18 years) with SCD and clinically relevant scores on PROMIS pain interference will be randomized into an intervention group and waiting list control group. Measurements will be done for the complete study population at inclusion (T0). In the intervention group, measurements will be done 2 weeks (T1i) and 3 months (T2i) after the end of EMDR sessions. Eight weeks after inclusion (T1c) will be performed for participants in the waiting list control group just before they receive EMDR treatment, and they are asked to complete measurements, 2 weeks (T1.1c) and 3 months after the end of EMDR sessions (T2c).

Intervention: After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. The waiting list control group will wait 9 weeks before starting EMDR therapy.

Conditions

Sickle Cell Disease; Pain; Pain, Chronic Disease

Study Design

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

Study Groups

EMDR intervention group

Measurements will be done for the complete study population at inclusion (T0). Participants randomized to the intervention group will start the EMDR therapy as soon as possible. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. In the intervention group, measurements will be done 2 weeks (T1i) and 3 months (T2i) after the end of EMDR sessions.

Group Type: ACTIVE_COMPARATOR

Eye Movement Desensitization and Reprocessing (EMDR)

Intervention Type: OTHER

The Dutch version of the standard EMDR protocol with age-specific adaptations for children and adolescents will be used. The eight phases consist of history taking, preparation, assessment, desensitization, installation, body scan, closure, and re-evaluation. During an EMDR session, the child focuses on emotionally disturbing memories (images, thoughts, emotions, and sensations) while simultaneously focusing on an external distracting stimulus (e.g., eye movements). This process facilitates accessing and desensitizing the traumatic memory network, so information processing is enhanced, and new associations can be made between the traumatic memory and more adaptive memories and information. As a result, the traumatic memory representation will be less intense and emotionally disturbing. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered.

Wait-list control group

Measurements will be done for the complete study population at inclusion (T0). Participants randomized to wait-list control group will wait for 9 weeks to start the therapy. Eight weeks after inclusion (T1c) will be performed for participants in the wait-list control group, just before they receive EMDR treatment. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. Participants of the wait-list control group are asked to complete measurements 2 weeks (T1.1c) and 3 months after the end of EMDR sessions (T2c).

Group Type: OTHER

Eye Movement Desensitization and Reprocessing (EMDR)

Intervention Type: OTHER

The Dutch version of the standard EMDR protocol with age-specific adaptations for children and adolescents will be used. The eight phases consist of history taking, preparation, assessment, desensitization, installation, body scan, closure, and re-evaluation. During an EMDR session, the child focuses on emotionally disturbing memories (images, thoughts, emotions, and sensations) while simultaneously focusing on an external distracting stimulus (e.g., eye movements). This process facilitates accessing and desensitizing the traumatic memory network, so information processing is enhanced, and new associations can be made between the traumatic memory and more adaptive memories and information. As a result, the traumatic memory representation will be less intense and emotionally disturbing. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered.

Interventions

Eye Movement Desensitization and Reprocessing (EMDR)

The Dutch version of the standard EMDR protocol with age-specific adaptations for children and adolescents will be used. The eight phases consist of history taking, preparation, assessment, desensitization, installation, body scan, closure, and re-evaluation. During an EMDR session, the child focuses on emotionally disturbing memories (images, thoughts, emotions, and sensations) while simultaneously focusing on an external distracting stimulus (e.g., eye movements). This process facilitates accessing and desensitizing the traumatic memory network, so information processing is enhanced, and new associations can be made between the traumatic memory and more adaptive memories and information. As a result, the traumatic memory representation will be less intense and emotionally disturbing. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered.

Intervention Type: OTHER

Other Intervention Names

EMDR therapy; EMDR treatment

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Karin Fijnvandraat

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Fijnvandraat, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Mariana Nery, MD

Role: CONTACT

m.c.nery@amsterdamumc.nl

+31 020 - 5666462

Linde Scholten

Role: CONTACT

linde.scholten@amsterdamumc.nl

+31 020 - 5666462

Facility Contacts

Mariana Nery

Role: primary

m.c.nery@amsterdamumc.nl

+31 020 - 5666462

Other Identifiers

RELAX

Identifier Type: OTHER

Identifier Source: secondary_id

NL86274.018.24

Identifier Type: -

Identifier Source: org_study_id