Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RELAX | Other Identifier | CCMO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD symptoms | The efficacy of EMDR in reducing PTSD symptoms. The Child and Adolescent Trauma Screen (CATS) questionnaire is a screening instrument based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD. It measures potentially traumatic events and PTSD symptoms (PTSS). The questionnaire consists of 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, and it is administered in approximately 15 minutes. The 4-point symptom response scales indicate the reported frequency/severity of each symptom. For children aged 6-7 years, using the caregiver-report version, the possible score range is 0-48, and the recommended cut-off point indicative of (sub)clinically relevant levels of symptoms is 12 points or more. For children aged 8 years and older, using the self-report version, the possible score range is 0-60, and the cut-off point is 15 points or more. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of EMDR intervention | EMDR treatment feasibility will be evaluated via a semi-structured interview performed by the researcher with the participants. | 2 weeks after end of treatment (T1i/T1.1c) |
| Pain and trauma related targets |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana Nery, MD | Contact | +31 020 - 5666462 | m.c.nery@amsterdamumc.nl | |
| Linde Scholten | Contact | +31 020 - 5666462 | linde.scholten@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Karin Fijnvandraat, prof. dr. | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010146 | Pain |
| D002908 | Chronic Disease |
| D000098644 | Vaso-Occlusive Crises |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 | The efficacy of EMDR in reducing anxiety. PROMIS Anxiety questionnaires assess fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). They assess anxiety over the past seven days (recall period). PROMIS T-scores are calculated per version, with higher T-scores representing greater 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 | The efficacy of EMDR in reducing depressive symptoms. PROMIS Depressive Symptoms questionnaires assess negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included, which eliminates consideration of these item's confounding effects when assessing children with comorbid physical conditions. The questionnaires are universal rather than disease-specific, making scores easily comparable to the general population. They assess depressive symptoms over the past seven days (recall period). The PROMIS T-scores are calculated per version. A higher PROMIS T-score represents more 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) | The efficacy of EMDR in reducing physical complaints. These questionnaires assess activities of physical mobility such as getting out of bed or a chair to activities such as running. They assess mobility over the past seven days (recall period). The PROMIS T-scores are calculated per version. A higher PROMIS T-score represents more mobility. | 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 | The efficacy of EMDR in reducing pain frequency. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and report for each day of the week if they had pain (yes/no). | 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 severity | The efficacy of EMDR in reducing pain severity. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and rate, for each day of the week that they had pain, the severity of the pain on a numeric rating scale (NRS, 0 - 10, 10 indicating the highest pain). It will also be investigated before and after each EMDR session using the same NRS, and will be registered by the therapist as part of the session report. | Inclusion (T0), before and after each EMDR session, 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2). |
| Use of pain medication | The efficacy of EMDR in reducing pain medication use. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and report for each day of the week any pain medication used. The (multiple-choice) options available are: no pain medication, paracetamol, diclofenac/ibuprofen, tramadol. | Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2). |
| School absence | The efficacy of EMDR in reducing school absence. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and report for each day of the week if they went to school (yes/no; if 'no' is chosen, they can also answer why, in a free text format). | Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2) |
The investigators aim to describe and summarize the pain-related traumatic experiences and irrational fears of the future that exist among the children in our target group.
During the intake, the psychologist will follow the standard procedure, in which the participant's pain-related traumatic experiences (targets) and irrational fears of the future (flash forwards) are identified by developing a case conceptualization, including a hierarchy in which these memories will be treated.
The investigators will create a systematic description (summary of intake's data) of these identified experiences and irrational fears of the future.
| Through intervention (intake and EMDR sessions), an average of 7 weeks. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |