Childhood Maltreatment, Traumatic Experiences and Stress-associated Parameters: Relationship and Influence on the Course of Illness in Schizophrenia Spectrum Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- PTSD symptom severity (PCL-5)
Study Overview
Brief Summary
Childhood maltreatment (CM) in psychotic disorders is 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 schizophrenia spectrum disorder and the further course of the disease.
The project is divided into two work programs and pursues:
- A detailed recording of the course of symptoms in participants with schizophrenia spectrum disorder to link this data with a systematic recording of CM and traumatic experiences and biological data.
- On a subsample of participants with schizophrenia spectrum disorder and a comorbid post-traumatic stress disorder (PTSD), the researchers want to investigate whether symptom traits of existing psychotic disorders, trauma-associated symptoms 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 CM 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 schizophrenia 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 project pursues a systematic assessment of CM and traumatic experiences as well as a detailed recording of the course of symptoms in participants with schizophrenia spectrum disorder. Furthermore, in a subsample of participants with schizophrenia spectrum disorder and comorbid PTSD, the researchers want to investigate whether symptom traits of existing psychotic disorders, trauma-associated parameters and cognitive functions can be influenced by a trauma-specific treatment (NET).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for the first work program:
- •- Patients with schizophrenia spectrum disorder
- •Inclusion Criteria for the second work program:
- •- Patients with schizophrenia spectrum disorder and comorbid PTSD Diagnosis (DSM-5)
Exclusion Criteria
- •(1st and 2nd work program):
- •mental impairment (e.g. dementia)
- •insufficient language comprehension
- •non-compliance with appointments
Outcomes
Primary Outcomes
PTSD symptom severity (PCL-5)
Time Frame: 1st. work program: at baseline. 2nd work program: Change from baseline (T0) to post treatment (T1; 1 week after completing NET) and 6-month follow-up (T2, 6 months after completing NET)
PTSD symptoms are measured in interview process (reporting period: previous 4 weeks) with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013).
cortisol awakening response (CAR), diurnal cortisol profile and corresponding hair cortisol concentration
Time Frame: only 1st work program: CAR at awaking, 30, 45 and 60 minutes after awakening; at noon (directly before lunch) and in the evening (directly before dinner); Hair cortisol concentration once
During the first hour after awakening saliva samples will be repeatedly collected following the established procedure.
Childhood maltreatment including parental bonding/family atmosphere
Time Frame: 1st and 2nd work program: at baseline.
CM are assessed using the Maltreatment and Abuse Chronology of Exposure scale (MACE; {Teicher, 2015 #73}; German version KERF by {Isele, 2014 #44}) developed to retrospectively assess exposure to ten types of CM from infancy to age 18, encompassing abuse (such as physical, verbal, and non-verbal emotional abuse, witnessing interparental and sibling abuse, peer-related verbal abuse and physical bullying, and intra-, extra-familial, or peer-related sexual abuse) as well as emotional and physical neglect.
Psychotic Symptom Severity
Time Frame: 1st workprogram: Change from admission to 4 weeks and 3 months after admission or if earlier at release; 2nd workprogram: Change of psychotic symptoms from baseline (T0) to post (T1; 1 week after completingNET) and 6 months follow-up (T2)
The course of psychotic symptoms is measured during inpatient treatment (from admission to study to 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).
Dissociation (Shut-D)
Time Frame: 1st. work program: at baseline. 2nd work program: Change from baseline (T0) to post-treatment (T1; 1 week after completing NET) and 6 months follow-up (T2; 6 months after completing NET)
Dissociative symptoms are assessed using the Shutdown Dissociation Scale (Shut-D), which measures the frequency of symptoms such as fainting, blurred vision, dizziness, altered hearing or vision, numbness, paralysis, and others {Schalinski, 2015 #46}. Participants reported the frequency of these symptoms over the past 6 months on a scale from 0 (not at all) to 3 (several times a week), with a total score ranging from 0 to 39.
Secondary Outcomes
- Suicidal tendenies(1st. workprogram: at baseline. 2nd work program: Change in suicidal tendencies is measured at baseline (T0), post-treatment (T1; within 1 week after completing NET) and 6 months follow-up (T2; 6 months after competing NET))
- MATRICS Consensus Cognitive Battery(only 2nd work program: Change in cognitive functions is measured at baseline (T0), post-treatment (T1; within 1 month after completing NET) and 6 months follow-up (T2; 6 months after completing NET))
- Changes in quality of life(1st. workprogram: at baseline. 2nd work program: Change in quality of life is measured at baseline (T0), post-treatment (T1; within 1 week after completing NET) and 6 months follow-up (T2; 6 months after completing NET))
- Depression Severity(1st. workprogram: at baseline. 2nd work program: Change in depression severity is measured at baseline (T0), post-treatment (T1; within 1 week after completing NET) and 6 months follow-up (T2; 6 months after completing NET))
Investigators
Michael Odenwald
Head of psychological outpatient clinic, head of psychology at the research ward
University of Konstanz