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

NCT07001631 | Recruiting

• 2 other identifiers: NL86274.018.24RELAX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Pain; Pain, Chronic Disease

Keywords

Pain; Pain Interference; Vaso-occlusive crisis; EMDR; PTSD

Outcome Measures

Primary Outcomes (1)

• Pain interference

  The PROMIS Short Form - Pain Interference 8a for measuring Pain Interference will be used. The PROMIS Pain Interference questionnaire assesses the pain impact on relevant aspects of one's life. This includes the extent to which pain affects social, cognitive, emotional, physical, and recreational activities. It also incorporates items probing sleep and enjoyment in life. The questionnaire assesses pain interference over the past seven days (recall period). A higher PROMIS T-score represents more pain interference. This scale ranges from 0 to 100 points. In his dissertation, Luijten reports that the general Dutch pediatric population reports a mean score of 39 points with a standard deviation of 10 points. Therefore, T-scores of 49 and above represent a (sub)clinical level of functioning. On a previous study from our group, children with severe SCD phenotype (n= 36) reported a mean score of 52.73 points (SD= 12.72), while the ones with less severe SCD phenotype (n= 54).

  Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

Secondary Outcomes (8)

• PTSD symptoms

  Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

• Anxiety

  Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

• Depressive symptoms

  Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

• Physical complaints (low moblity)

  Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

• Pain frequency

  Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

Other Outcomes (2)

• Feasibility of EMDR intervention

  2 weeks after end of treatment (T1i/T1.1c)

• Pain and trauma related targets

  Through intervention (intake and EMDR sessions), an average of 7 weeks.

Study Arms (2)

EMDR intervention group

ACTIVE COMPARATOR

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.

Other: Eye Movement Desensitization and Reprocessing (EMDR)

Wait-list control group

OTHER

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).

Other: Eye Movement Desensitization and Reprocessing (EMDR)

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) 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.

Also known as: EMDR therapy, EMDR treatment

EMDR intervention group; Wait-list control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain; Chronic Disease; Vaso-Occlusive Crises; Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karin Fijnvandraat, prof. dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana Nery, MD

CONTACT

+31 020 - 5666462; m.c.nery@amsterdamumc.nl

Linde Scholten

CONTACT

+31 020 - 5666462; linde.scholten@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 3, 2025
• Study Start: September 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-03

Locations

NL (1)