Narrative Exposure Therapy in Patients With Psychotic Disorders and a Posttraumatic Stress Disorder (NETPSYCH)
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|ClinicalTrials.gov Identifier: NCT03730831|
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Adverse childhood experiences in psychotic disorders are associated with increased cognitive deficits, severe psychotic symptoms, and increased comorbidity. The number of different stress experiences also increases the probability of trauma-associated symptoms. Furthermore, neurobiological changes play a key role in the vulnerability of individuals with early traumas for mental and physical illnesses, among others for diseases of the schizophrenic spectrum disorder and the further course of the disease.
The current project pursues a detailed recording of the course of symptoms in inpatients with psychosis to link this data with a systematic recording of childhood experiences and traumatic experiences and biological data.
On a subsample of inpatients with psychosis and a comorbid post-traumatic stress disorder (PTSD), the researchers want to investigate whether symptom traits of existing psychotic disorders, biomolecular parameters and cognitive functions can be influenced by a trauma-specific treatment (NET), that has been proven to be effective in the treatment of PTSD.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia PTSD||Behavioral: Narrative Exposure Therapy||Not Applicable|
Numerous scientific findings point to the influence of stressful childhood experiences and traumatic experiences on the risk of mental and physical illnesses, their severity and their course. Traumatic experiences also increase the risk of demonstrating psychotic symptoms or even develop psychotic disorders. Furthermore, the number of different stress experiences also increases the probability of trauma-associated symptoms (symptoms of post-traumatic stress disorder (PTSD) and dissociative experiences).
Neurobiological changes in the immune system, the defense of stress and also central nervous circuits and structures play a key role in the vulnerability of individuals with early traumas for mental and physical illnesses, e.g. for diseases of the schizophrenic spectrum disorder and the further course of the disease.
The recording of stressful and traumatic life experiences has been largely neglected in everyday clinical practice, especially in patients with a schizophrenia spectrum disorder. The diagnosis of PTSD is rarely given in everyday clinical practice, so that trauma-specific treatment is often not offered.
The targeted use of a scientifically proven intervention to reduce the symptoms of PTSD (NET: Narrative Exposure Therapy) involves a change in stress-associated biomolecular parameters and normalizes neuronal brain activity.
The current project pursues a systematic recording of childhood experiences and traumatic experiences possibly experienced as stressful as well as a detailed recording of the course of symptoms in inpatients with psychosis. The researchers want to investigate whether symptom traits of existing psychotic disorders, biomolecular parameters and cognitive functions can be influenced by a trauma-specific treatment (NET).
The current project thus is divided into two work programs:
- The first work program includes a weekly prospective assessment of psychotic symptoms on a sample of n=100 inpatients and links this data with results from a cross-sectional review of traumatic and distressing childhood experiences and biological data (cortisol awakening, tonic cortisol concentration in hair and determination of mitochondrial respiratory activity in mononuclear cells).
- The second work program includes the subgroup of psychotic patients with comorbid PTSD (n=20) and includes a randomized controlled pilot study to determine the impact of trauma therapy (NET) on the course of symptoms. In addition to the symptoms of PTSD, psychosis-specific parameters such as cognitive functions and biological characteristics will be repeatedly recorded pre and post (6 months and 12 months after completing trauma therapy).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Narrative Exposure Therapy in Patients With Psychotic Disorders and a Posttraumatic Stress Disorder|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Narrative Exposure Therapy The Narrative Exposure Therapy (NET) is a brief manualized trauma-focussed treatment and will be performed according to the manual of Schauer et al., 2011. In the NET the experiences experienced as traumatic are worked on and placed in the context of the entire life story.
Behavioral: Narrative Exposure Therapy
8-10 sessions: 1 lifeline session, 6-10 sessions narrative exposure, 1-2 sessions of future-oriented counselling
No Intervention: Control
- Psychotic Symptom Severity [ Time Frame: Change from from admission to study (T1) to T2 (4 weeks after admission) to T3 (3 months after admission or - if released earlier - at release from inpatient treatment) ]The course of psychotic symptoms is measured during inpatient treatment (from admission to study until release from inpatient treatment, typically for 6-8 weeks) with the Positive and Negative Syndrome Scale (PANSS; Kay, S. R., Fiszbein, A., & Opfer, L. A. (1987). The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophrenia Bulletin, 13 (2), 261.
- PTSD symptom severity (PCL-5) [ Time Frame: Change from baseline (T1) to 6 and 12 months follow-up ]PTSD symptoms are measured by self-report (reporting period: previous 4 weeks) with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013).
- cortisol awakening response (CAR) [ Time Frame: at awaking, 30 min, 45 min and 60 min after awakening ]During the first hour after awakening saliva samples will be repeatedly collected following the established procedure.
- MATRICS Consensus Cognitive Battery [ Time Frame: Change in cognitive functions is measures pre intervention (T1) and 4 weeks after T1, as well as 6 and 12 months after T1 ]Cognitive change is measures with the MATRICS Consensus Cognitive Battery (Nuechterlein, K. H., Green, M. F., Kern, R. S., Baade, L. E., Barch, D. M., Cohen, J. D., ... & Goldberg, T. (2008). The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. American Journal of Psychiatry, 165 (2), 203-213.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730831
|Contact: Michael Odenwald, Dr. rer. nat.||+49 7531 email@example.com|
|Contact: Susanne Breinlinger, MA|
|University of Konstanz, Psychotherapy Outpatient Clinic||Recruiting|
|Konstanz, Germany, 78464|
|Contact: Michael Odenwald, PhD +49 7531 884621 firstname.lastname@example.org|
|Contact: Anne Schawohl, MA +49 7531 883589 email@example.com|