|- candidate number||25200|
|- NTR Number||NTR5991|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-aug-2016|
|- Secondary IDs||NL 56641.044.16 CCMO / METC Twente|
|- Public Title||Treatment of Complex PTSD|
|- Scientific Title||Phase-based treatment versus direct trauma-focused treatment in patients with Complex PTSD|
|- ACRONYM||ToPrepareOrNot (TOPRON)|
|- hypothesis||According to the guidelines of the International Society of Traumatic Stress Studies (ISTSS), treatment should be ‘phase-based’, indicating that patients with Complex PTSD symptoms will profit more from trauma-focused treatment if this phase in treatment is preceded by a stabilization phase aimed at achieving patient safety and improving emotion regulation, patients’ positive self-concept, and interpersonal skills. |
In accordance with the ISTSS guidelines, it would be expected that a phase-based treatment (EMDR preceded by STAIR ) is significantly more effective with regard to PTSD (PTSD severity), would lead to a significantly better outcome in terms of comorbid symptom decrease, a lower drop-out rate, and increased quality of life, than when the direct trauma-focused treatment (EMDR alone ) is applied.
|- Healt Condition(s) or Problem(s) studied||Post traumatic stress disorder, EMDR|
|- Inclusion criteria||In order to be eligible to participate in this study, a patient must meet all of the following criteria: a) meeting the criteria for PTSD, according to the Clinical-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013), b) having symptoms of Complex PTSD, c) reporting a history of repeated physical and/or sexual abuse by a caretaker or person in authority during childhood (before the age of 18), d) being in the age between 18 and 65 years, e) giving an informed consent for study participation. |
|- Exclusion criteria||A patient who meets any of the following criteria will be excluded from participation in this study: a) insufficient competence in speaking the Dutch language, b) high risk of suicidality assessed by the BDI-II (Beck, Steer, and Brown, 1996), c) currently in treatment for PTSD, d) severe alcohol or drug dependence or abuse, e) IQ under 80, and f) victim of ongoing physical and/or sexual abuse. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-sep-2016|
|- planned closingdate||31-dec-2019|
|- Target number of participants||122|
|- Interventions||EMDR alone (16 sessions) versus EMDR (16 sessions) preceded by STAIR (stabilization program)|
|- Primary outcome||Severity of PTSD symptoms |
|- Secondary outcome||Secondary parameters include the presence of a PTSD diagnosis, severity of Complex PTSD symptoms and comorbid symptoms (i.e., anxiety, depression, general psychopathology), dissociation, health-related quality of life and drop out during treatment in both conditions. |
|- Timepoints||Patients will be subjected to a series of measures before, during and after treatment and at 3 and 6 months follow-up. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Noortje van Vliet|
|- CONTACT for SCIENTIFIC QUERIES|| Noortje van Vliet|
|- Sponsor/Initiator ||University of Amsterdam (UvA), University of Groningen|
(Source(s) of Monetary or Material Support)
|- Publications||1. Study protocol.|
2. Article about the results of the RCT in which phase-based treatment versus directe trauma-focused treatment are compared in patients with Complex PTSD.
3. Article about cost-effectiveness of both treatments.
4. Article about predictors and moderators in the treatment of Complex PTSD.
5. Article about possible predictors of worse outcome and drop-out in the treatment of Complex PTSD.
|- Brief summary||Complex Post Traumatic Stress Disorder (Complex PTSD) is a term used to denote a severe form of PTSD following repeated interpersonal traumatization in childhood. This construct comprises symptom clusters reflecting difficulties in regulating emotions, disturbances in relational capacities, alterations in attention and consciousness, adversely affected belief systems, and somatization. According to the guidelines of the International Society of Traumatic Stress Studies (ISTSS), treatment should be ‘phase-based’, indicating that patients with Complex PTSD symptoms will profit more from trauma-focused treatment if this phase in treatment is preceded by a stabilization phase aimed at achieving patient safety and improving emotion regulation, patients’ positive self-concept, and interpersonal skills. However, superiority of a phase-based approach starting with a stabilization phase is yet to be established.
The purpose of the present study is to determine superiority in efficacy of a phase-based treatment (i.e., EMDR therapy preceded by Skills Training in Affective and Interpersonal Regulation, STAIR) versus trauma-focused treatment alone (i.e., EMDR therapy) to treat individuals suffering from (Complex) PTSD due to a history of repeated sexual and/or physical abuse in childhood (by a caretaker or person in authority, and before the age of 18). Our first aim is to test the hypothesis that a phase-based treatment (EMDR preceded by STAIR) is significantly more effective with regard to PTSD (decrease of PTSD symptoms), would lead to a significantly better outcome in terms of comorbid symptom decrease, lower drop-out rate, and increased quality of life, than when the direct trauma-focused treatment (EMDR alone) is applied. Our second aim is to identify possible predictors of worse outcome and drop-out (e.g. pre-treatment anxiety, depression, and personality disorders).
|- Main changes (audit trail)|
|- RECORD||23-aug-2016 - 16-sep-2016|