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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
Sponsor:
Collaborator:
Centre for Psychiatry Reichenau
Information provided by (Responsible Party):
Michael Odenwald, University of Konstanz

Brief Summary:

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

Detailed Description:

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:

  1. 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).
  2. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
Waiting List



Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with schizophrenia spectrum disorder
  • for treatment and non treatment group: Patients with schizophrenia spectrum disorder and comorbid PTSD Diagnosis (DSM-5)

Exclusion Criteria:

  • Patients not able to participate in trauma-focused therapy due to mental impairment (e.g. dementia)
  • non-compliance with appointments

Information from the National Library of Medicine

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


Contacts
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Contact: Michael Odenwald, Dr. rer. nat. +49 7531 884621 michael.odenwald@uni-konstanz.de
Contact: Susanne Breinlinger, MA

Locations
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Germany
University of Konstanz, Psychotherapy Outpatient Clinic Recruiting
Konstanz, Germany, 78464
Contact: Michael Odenwald, PhD    +49 7531 884621    michael.odenwald@uni-konstanz.de   
Contact: Anne Schawohl, MA    +49 7531 883589    anne.schawohl@uni-konstanz.de   
Sponsors and Collaborators
University of Konstanz
Centre for Psychiatry Reichenau

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Responsible Party: Michael Odenwald, Head of psychological outpatient clinic, head of psychology at the research ward, University of Konstanz
ClinicalTrials.gov Identifier: NCT03730831     History of Changes
Other Study ID Numbers: NET PSYCH 2018
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Odenwald, University of Konstanz:
Course
Schizophrenia spectrum disorder
Posttraumatic Stress Disorder
Narrative Exposure Therapy

Additional relevant MeSH terms:
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Schizophrenia
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Trauma and Stressor Related Disorders