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

Schizophrenia Clinical Trial

— NETPSYCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730831
• Other study ID #: NET PSYCH 2018
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: University of Konstanz
• Contact: Michael Odenwald, Dr. rer. nat.
• Phone: +49 7531 884621
• Email: michael.odenwald[@]uni-konstanz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• PTSD
• Schizophrenia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Narrative Exposure Therapy
8-10 sessions: 1 lifeline session, 6-10 sessions narrative exposure, 1-2 sessions of future-oriented counselling

Locations

Country	Name	City	State
Germany	University of Konstanz, Psychotherapy Outpatient Clinic	Konstanz

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	Centre for Psychiatry Reichenau

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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).	Change from baseline (T1) to 6 and 12 months follow-up
Secondary	cortisol awakening response (CAR)	During the first hour after awakening saliva samples will be repeatedly collected following the established procedure.	at awaking, 30 min, 45 min and 60 min after awakening
Secondary	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.	Change in cognitive functions is measures pre intervention (T1) and 4 weeks after T1, as well as 6 and 12 months after T1