Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: Participants are randomly assigned to one of four arms. Randomization is conducted by the independent randomisation bureau of Parnassia Psychiatric Institute with the use of block randomisation with the randomisation software from www.randomizer.org. Research Randomizer (Version 4.0). The three experimental arms consist of Prolonged Exposure therapy (PE), Eye Movement Desensitization and Reprocessing (EMDR), and Cognitive Restructuring (CR) therapy. The control arm is a waiting list group up to the 6‐month follow‐up, after which they may choose to receive a trauma‐focused treatment of choice. All therapists will deliver PE, EMDR and CR and will be trained in all the protocols. Participants in the three treatment arms will receive a maximum of 16 sessions. Sessions will be held two times a week and will last 90 minutes. The PE therapy will be delivered conforming to the protocol of Foa, Hembree and Rothbaum (2007). This protocol consists of imaginal exposure (whereby each session is audio recorded and participants listen to these recordings five times per week) and in vivo exposure (based on a list of avoided trauma‐related stimuli). EMDR will be delivered according to the standard 8‐phase protocol by Shapiro, using the Dutch translation of the EMDR protocol. Eye movements will be applied as the default dual attention stimulus. The CR therapy will be delivered based on the treatment program developed by Mueser, Rosenberg, Jankowski, Hablen and Monica (2004). This adapted cognitive restructuring treatment is based on cognitive models of PTSD that posit that appraisals of traumatic events, and subsequent attempts to cope with the associated negative affect, are the key factors in the development and maintenance of PTSD. The most important adaptation of this CR protocol is the exclusion of direct memory processing since the developers expected that direct trauma memory processing would CONDITION: Post‐traumatic stress symptoms in patients with chronic post‐traumatic stress disorder and a comorbid psychotic disorder in the schizophrenia spectrum ; Mental and Behavioural Disorders ; Post‐traumatic stress disorder PRIMARY OUTCOME: Researcher‐rated changes in severity of PTSD symptoms as measured by the Clinician‐Administered PTSD Scale for DSM‐5 (CAPS‐5). This will be measured at baseline, at 7 weeks (mid‐treatment), 13 weeks (post‐treatment), 6‐month follow‐up, 12‐month follow‐up, and 24‐month follow‐up. INCLUSION CRITERIA: 1. Age 16+ years 2. A lifetime diagnosis of a psychotic disorder in the schizophrenia spectrum, confirmed by the Structured Clinical Interview for DSM‐5 (SCID‐5) 3. Full DSM‐5 diagnostic criteria for chronic PTSD on the Clinician‐Administered PTSD Scale for DSM‐5 (CAPS‐5) with a minimum score =23 4. Willingness to undergo randomisation and a trauma‐focused therapy SECONDARY OUTCOME: ; 1. Changes in the number of participants fulfilling the diagnostic criteria of PTSD ‐ CAPS‐5; 2. Self‐rated severity of PTSD symptoms, measured using PTSD Checklist for the DSM‐5 (PCL5); 3. Severity of complex PTSD symptoms, measured using International Trauma Questionnaire (ITQ); 4. Posttraumatic cognitions, measured using Brief version of the Posttraumatic Cognitions Inventory (PTCI‐9); 5. Dissociation, measured using Trait State Dissociation Questionnaire short version (TSDQ‐s); 5. Depression symptoms, measured usingBeck Depression Inventory II (BDI‐II); 6. Paranoia, measured using Green et al. Paranoid Thought Scales (GPTS); 7. Auditory verbal hallucinations, measured using Psychotic symptoms rating scales (PSYRATS) & Voice Impact Scale (VIS); 8. Disruption of social functioning by PTSD symptoms, measured using ITQ; 9. Resilience, measured using Brief Resilience Scale (BRS); 10. Personal recovery, measured using Questionnaire about the Process of Recovery (QPR); 11. Sexual functioning, measured using Arizona Sexual Experience Scale (ASEX) & Sexual Autonomy Scale (SAS); 12. Social functioning measured with 2 items adapted from the Time Use Survey; 13. Adversities measured using the 7‐item TTIP Adverse Events Questionnaire; 14. Revictimization, measured using Trauma and Life Events Checklist (TALE); Measures 1‐11 will be measured at baseline, at 7 weeks (mid‐treatment), 13 weeks (post‐treatment), 6‐month follow‐up, 12‐month follow‐up, and 24‐month follow‐up.; Measures 12‐14 will be measured weekly from baseline until 6‐month follow‐up.; ;
Epistemonikos ID: 8b4a6e49a342c5c8221f954ff8ad683f6550ba7b
First added on: Aug 24, 2024