A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis

Trials

Agnes van Minnen¹  Mark van der Gaag⁴  Ad de Jongh²  Eni S Becker¹  Cornelis L Mulder³  Carlijn de Roos⁵  Berber M van der Vleugel⁶  David PG van den Berg⁴  Paul AJM de Bont¹ 

[1] Behavioural Science Institute, NijCare, Radboud University, Montessorilaan 3, P.O. Box 9104, Nijmegen, 6525 HR, The Netherlands;Department of Behavioral Sciences, Academic Centre for Dentistry Amsterdam (ACTA), VU University Amsterdam, Gustav Mahler Laan 3004, Amsterdam, 1081 LA, The Netherlands;Department of Psychiatry, and BavoEuropoort, University Medical Center Rotterdam, Dr. Molewaterplein 50, Rotterdam, 3015 GE, The Netherlands;Department of Clinical Psychology, VU University Amsterdam and EMGO Institute for Health and Care Research, Van der Boechorststraat 1, Amsterdam, 1081 BT, the Netherlands;MHO Rivierduinen, Schuttersveld 9, P.O. Box 2211, Leiden, 2316 XG, the Netherlands;MHO GGZ Noord-Holland Noord, Oude Hoeverweg 10, Alkmaar, 1816 BT, The Netherlands

关键词: Mediators;    Moderators;    Economic evaluation;    EMDR;    Prolonged exposure;    Working memory;    Hallucinations;    Schizophrenia;    Trauma;    PTSD;    Psychosis;   

Others  :  1093893
DOI  :  10.1186/1745-6215-14-151

 received in 2012-11-18, accepted in 2013-04-30,  发布年份 2013

【 摘 要 】

Background

Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study’s primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists.

Methods/Design

A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, twomonths post treatment, and six monthspost treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up.

Discussion

The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change.

Trial registration

Trial registration:ISRCTN79584912

【 授权许可】

   
2013 de Bont et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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