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Narrative Exposure Therapy in Patients With Psychotic Disorders and a Posttraumatic Stress Disorder (NETPSYCH)

Primary Purpose

Schizophrenia, PTSD

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Course, Schizophrenia spectrum disorder, Posttraumatic Stress Disorder, Narrative Exposure Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Konstanz, Psychotherapy Outpatient ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Waiting List

Outcomes

Primary Outcome Measures

Psychotic Symptom Severity
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)
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

cortisol awakening response (CAR)
During the first hour after awakening saliva samples will be repeatedly collected following the established procedure.
MATRICS Consensus Cognitive Battery
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.

Full Information

First Posted
July 5, 2018
Last Updated
March 23, 2020
Sponsor
University of Konstanz
Collaborators
Centre for Psychiatry Reichenau
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1. Study Identification

Unique Protocol Identification Number
NCT03730831
Brief Title
Narrative Exposure Therapy in Patients With Psychotic Disorders and a Posttraumatic Stress Disorder
Acronym
NETPSYCH
Official Title
Narrative Exposure Therapy in Patients With Psychotic Disorders and a Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Centre for Psychiatry Reichenau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, PTSD
Keywords
Course, Schizophrenia spectrum disorder, Posttraumatic Stress Disorder, Narrative Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waiting List
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Intervention Description
8-10 sessions: 1 lifeline session, 6-10 sessions narrative exposure, 1-2 sessions of future-oriented counselling
Primary Outcome Measure Information:
Title
Psychotic Symptom Severity
Description
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.
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)
Title
PTSD symptom severity (PCL-5)
Description
PTSD symptoms are measured by self-report (reporting period: previous 4 weeks) with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013).
Time Frame
Change from baseline (T1) to 6 and 12 months follow-up
Secondary Outcome Measure Information:
Title
cortisol awakening response (CAR)
Description
During the first hour after awakening saliva samples will be repeatedly collected following the established procedure.
Time Frame
at awaking, 30 min, 45 min and 60 min after awakening
Title
MATRICS Consensus Cognitive Battery
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Odenwald, Dr. rer. nat.
Phone
+49 7531 884621
Email
michael.odenwald@uni-konstanz.de
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Breinlinger, MA
Facility Information:
Facility Name
University of Konstanz, Psychotherapy Outpatient Clinic
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Odenwald, PhD
Phone
+49 7531 884621
Email
michael.odenwald@uni-konstanz.de
First Name & Middle Initial & Last Name & Degree
Anne Schawohl, MA
Phone
+49 7531 883589
Email
anne.schawohl@uni-konstanz.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Narrative Exposure Therapy in Patients With Psychotic Disorders and a Posttraumatic Stress Disorder

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