Sickle cell disease
Conditions
Interventions
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 wait-list contr
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion 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
Exclusion criteria: • Undergone succesful 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes is pain interference in the child*s life, measured with PROMIS Pain Interference questionnaire. PROMIS Pain Interference (parent-report for children aged 6-7 and pediatric self-report from 7 years on): We will use the PROMIS Short Form - Pain Interference 8a for measuring Pain interference. The PROMIS Pain Interference questionnaire assess 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 0-100 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 (sub)clinical level of functioning. On previous study from our group (submitted), 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) reported a mean score of 47.35 points (SD= 13.82). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Severity of PTSD symptoms during/after intervention: PTSD symptoms score reported via the Child and Adolescent Trauma Screen (CATS) questionnaire (parent-report for children aged 6-7 and pediatric self-report from 7 years on): 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 is a measure of potentially traumatic events and of PTSS. These questionnaires are composed of 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, and is administered in approximately 15 minutes. The 4-point symptom response scales indicate the reported frequency/severity of each symptom. For the children aged 6 years, using the Caregiver-report, the possible score range is 0 - 48, and the recommended cut-off point indicative of (sub)clinically relevant level of symptoms is of 12 points or more. For children aged 7 years and older, using the Self-report version, the possible score range is 0 - 60, and the cut-off point is of 15 points or more. • Anxiety of participants (parent-report for children aged 6-7 and pediatric self-report from 7 years on): General anxiety score reported via PROMIS Anxiety questionnaire: PROMIS Anxiety questionnaires assess the 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). The PROMIS T-scores are calculated per version. A higher PROMIS T-score represents more anxiety. • Depressive symptoms of participants (parent-report for children aged 6-7 and pediatric self-report from 7 years on): PROMIS Depressive Symptoms questionnaires assess negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cogniti | — |
Countries
Netherlands
Outcome results
None listed