|- candidate number||14428|
|- NTR Number||NTR3870|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-feb-2013|
|- Secondary IDs||2009-KP-734 Commissie Ethiek, Afdeling Psychologie, UvA|
|- Public Title||EMDR versus Cognitive Behavioral Writing Therapy (CBWT): A RCT.|
|- Scientific Title||A Randomized Comparison of Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Writing Therapy (CBWT) in pediatric posttraumatic stress disorder following single- incident trauma.|
|- ACRONYM||EMDR versus CBWT|
|- hypothesis||Treatment of posttraumatic symptoms with EMDR as well as with CBWT will lead to symptom reduction in the short and long term. We hypothesize that EMDR will lead to faster improvements in PTSD symptoms and that the effects in the end will be equal.|
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD), Posttraumatic stress symptoms|
|- Inclusion criteria||1. Age between 8 and 18 years;|
2. Having experienced a single traumatic event;
3. Presence of 5 posttraumatic stress symptoms after 1 month;
4. Sufficient knowledge of the Dutch language.
|- Exclusion criteria||1. Acute psychiatric problems (suicidality, psychosis);|
2. IQ lower than 80.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-jun-2014|
|- Target number of participants||110|
|- Interventions||Eye Movement Desensitisation and Reprocessing (EMDR) and Cognitive Behavioral Writing Therapy (CBWT). A Waiting List Group is included.
EMDR is a treatment for traumatic memories and their sequelae requiring the client to attend a distracting (or “dual attention”) stimulus typically the therapist’s fingers moving back and forth in front of client’s face while concentrating on the trauma memory (Shapiro, 2001). Briefly, EMDR treatment consists of (1) Taking history and planning treatment. (2) Explanation of and preparation for EMDR. (3) Preparation of the target memory. (4) Desensitization of the memory. (5) Guiding the client to embrace a relevant positive belief regarding the event. (6) Identification and processing of any residual disturbing body sensations. (7) Closure of the session. (8) Re-evaluation.
For this study, a maximum number of six session is permitted.
CBWT is a trauma treatment (Van der Oord et al., 2009) where the child writes a report of the traumatic event(s) on the computer in the therapy room. The therapist helps the child with writing down a detailed account of the child’s thoughts, feelings and behaviours during the traumatic event. The most important elements of CBWT are psycho-education, exposure, cognitive restructuring, promoting adequate coping and social sharing.
For this study, a maximum number of six sessions is permitted.
|- Primary outcome||Self-reported and parent-reported PTSD symptoms (SVLK and the ADIS/C).|
|- Secondary outcome||Secondary outcomes are anxiety, depression, somatic and behavioral symptoms, quality of life, posttraumatic cognitions, somatic symptoms, posttraumatic growth. |
|- Timepoints||Assessment take place at four time points:|
2. Post treatment;
3. Follow-up three months after treatment;
4. Follow-up 12 months after treatment.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Carlijn Roos, de|
|- CONTACT for SCIENTIFIC QUERIES|| Carlijn Roos, de|
|- Sponsor/Initiator ||Psychotrauma Centre for Children and Youth, MHI Rivierduinen|
(Source(s) of Monetary or Material Support)
|- Brief summary||The main objectives of the present study are: assessing the efficacy and efficiency of EMDR and TBWT in children aged 8-18 years with posttraumatic stress reactions following single- incident trauma. |
|- Main changes (audit trail)|
|- RECORD||22-feb-2013 - 10-mrt-2013|