|- candidate number||20917|
|- NTR Number||NTR4909|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-nov-2014|
|- Secondary IDs||COS20143 Dimence|
|- Public Title||Effect of EMDR treatment on trauma and autism symptoms in adults with ASD|
|- Scientific Title||Effect of EMDR on symptoms of PTSD and ASD in adults with ASD|
|- hypothesis||The effect of EMDR in adults with autism has not been studied before. Hypothesis is that the severity of traumarelated symptoms decreases after treatment with 8 sessions EMDR in comparison of treatment as usual. There are indications of diagnostic overshadowing of trauma in people with ASD. Hypothesis is that autism symptoms may decrease too, especially those that show symptomatic overlap with traumarelated symptoms. Results contribute to the development of effective treatment of trauma for adults with ASD. This can lead to a reduction in symptoms and thus emotional, personal and social costs. In addition, results may contribute to the prevention of possible diagnostic overshadowing and undertreatment of traumarelated symptoms in adults with ASD.|
|- Healt Condition(s) or Problem(s) studied||EMDR, Autism Spectrum Disorders (ASDs), Post-Traumatic Stress Disorder (PTSD)|
|- Inclusion criteria||Normally intelligent adults of 18 years and older with ASD and (symptoms of) PTSD who receive outpatient treatment. ASD is diagnosed by a qualified psychiatrist or psychologist in accordance with the multidisciplinary guideline on the diagnosis and treatment of autism spectrum disorders in adults (Kan et al., 2013).|
Perceived burden of traumatic events: the inclusion criterion is a score of 4 or higher on the visualized thermometer, belonging to the modified ADIS, section PTSD.
Permission to make video or audio recordings for supervision and assessing therapy integrity.
|- Exclusion criteria||No command of the Dutch language.|
Current psychotic symptoms.
Current manic symptoms.
Under the influence of alcohol, drugs and sedatives during the treatment sessions.
Patients who need more than 8 sessions EMDR because of the severity of the symptoms (usually complex PTSD).
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-nov-2014|
|- planned closingdate||15-mrt-2016|
|- Target number of participants||16|
|- Interventions||In this quasi- experimental study, the patient is his own control. There are three measurements and one follow-up measurement. During the intake of EMDR is determined whether EMDR is an appropriate intervention. The patient is asked via informed consent if he or she wants to participate in the study. Then a regular waiting period of 6 to 8 weeks follows and treatment as usual (TAU) is offered. TAU consists of psycho-education or counseling. The second measurement takes place after the waiting period and before the start of EMDR. After a maximum of eight EMDR sessions of 90 minutes is the third measurement. After a follow up period of eight weeks is the fourth and final measurement.|
All therapist are well educated EMDR-therapists and are known with working with adults with ASD. During the EMDR treatment the EMDR-therapists receive supervision of an EMDR-supervisor.
|- Primary outcome||Severity of symptoms associated with PTSD, as measured by the Impact of Event Scale Revised (IES-R), decreases significantly after treatment with EMDR.|
|- Secondary outcome||1. The perceived burden of PTSD symptoms, as measured by a score at a visualized thermometer reduces with 2 points after treatment with EMDR. The thermometer belongs to the modified Anxiety Disorders Interview Schedule for DSM-IV (ADIS) section PTSD.|
2: The number of symptoms associated with ASD, as measured with the Social Responsiveness Scale-Adults (SRS-A), decreases significantly after treatment with EMDR.
3: Frequency of self-reported psychological symptoms, as measured by the Brief Symptom Checklist (BSI) decreases significantly after treatment with EMDR.
|- Timepoints||Measurement 1: modified ADIS, section PTSD (traumas and symptoms); IES-R; SRS-A; BSI.
6 t 8 weeks waiting period and TAU.|
Measurement 2: modified ADIS, section PTSD (symptoms); IES-R; SRS-A; BSI.
A maximum of 8 sessions EMDR of 90 minutes.
Measurement 3: modified ADIS, section PTSD (symptoms); IES-R; SRS-A; BSI.
Follow up periode of 6 to 8 weeks.
Measurement 4: modified ADIS, section PTSD (symptoms); IES-R; SRS-A; BSI.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P.H. (Ella) Lobregt-van Buuren|
|- CONTACT for SCIENTIFIC QUERIES|| P.H. (Ella) Lobregt-van Buuren|
|- Sponsor/Initiator ||Dimence|
(Source(s) of Monetary or Material Support)
|Vereniging EMDR Nederland (VEN), Dokter Wittenberg Stichting|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||12-nov-2014 - 3-jan-2015|