Eye Movement Desensitization and Reprocessing (EMDR) in children with a medically related trauma: a randomized controlled trial

Completed

Conditions: alle kinderen die via SEH acuut opgenomen worden i.v.m. een acute interne of chirurgische aandoeningen
Congenital heart disease (being born with a heart defect) and acute internal or surgical conditions
10010394

Registration Number: NL-OMON47373

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 78

Inclusion Criteria

eligible are all consecutive patients who 1) underwent one or more admissions to a hospital between July 2011 and April 2018 (time between the baseline screening for this study and the prior admission is at least 4 weeks up to maximally 5 years ago) and 2) are 4-16 years old during the inclusion period (July 2016 * May 2018), encompassing:
1) previously healthy children (with no underlying chronic illness/handicap) admitted to the hospital for the first time via the emergency department and children who had a one-time hospitalization at the department of child cardiology (trauma type I); and
2) patients with recurrent admissions via the emergency department or at the department of child cardiology or children who had a medical procedure (e.g. surgery) apart from a one-time admission (trauma type II).

Exclusion Criteria

Mental retardation, inability to read or write Dutch, previous psychological treatment for PTSD symptoms, epilepsy.
For exclusion in the RCT: children with a score below the 60th percentile on the SVLK and/or meeting less than 2 of the 3 SVLK PTSD subscales, and children with a clinical, psychiatric posttraumatic sress disorder (measured by the CAPS-CA/DIPA)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint:<br /><br>- Difference in PTSD symptoms (measured with the SPPC) between EMDR and CAU<br /><br>group on T1 (baseline), T2 (2 weeks after the completion of EMDR therapy or<br /><br>CAU) and T3 (6 months follow-up)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints, assessed at T1, T2, T3:<br /><br><br /><br>Psychosocial functioning<br /><br>Quality of life<br /><br>Sleep<br /><br>Self-perception<br /><br>Attention (problems):<br /><br>School functioning<br /><br>Medical consumption/adherence:<br /><br><br /><br><br /><br>Predictor variables, assessed at T1:<br /><br><br /><br>demographic factors<br /><br>cognitive coping styles<br /><br>stressful life events, s<br /><br>Somatic complaints,<br /><br>information regarding surgery and painful procedures.</p><br>