Childhood Maltreatment, Traumatic Experiences and Stress-associated Parameters in Schizophrenia Spectrum Disorders

NCT03730831 | Completed

• 1 other identifier: NET PSYCH 2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:

1. 1.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.
2. 2.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.

Conditions

Schizophrenia Spectrum Disorder; PTSD

Keywords

Course; Schizophrenia Spectrum Disorder; Posttraumatic Stress Disorder; Narrative Exposure Therapy

Outcome Measures

Primary Outcomes (5)

• PTSD symptom severity (PCL-5)

  PTSD symptoms are measured in interview process (reporting period: previous 4 weeks) with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013).

  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)

• Psychotic Symptom Severity

  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).

  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)

• Dissociation (Shut-D)

  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.

  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)

• Childhood maltreatment including parental bonding/family atmosphere

  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.

  1st and 2nd work program: at baseline.

• cortisol awakening response (CAR), diurnal cortisol profile and corresponding hair cortisol concentration

  During the first hour after awakening saliva samples will be repeatedly collected following the established procedure.

  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

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Intervention (second work program)

EXPERIMENTAL

Narrative Exposure Therapy Narrative Exposure Therapy (NET) is a brief manualized trauma-focussed psychotherapeutic treatment and will be performed according to the manual of Schauer et al., 2011. In NET, traumatic experiences are worked through and placed in the context of the entire life story.

Behavioral: Narrative Exposure Therapy

Interventions

Narrative Exposure Therapy BEHAVIORAL

8-20 sessions: 1 lifeline session, 6-17 sessions narrative exposure, 1-2 sessions of future-oriented counselling -\> Intervention is a part of the second work program. First work program focueses on cross-sectional data and includes a systematic record of psychopathology in participants with schizophrenia sepctrum disorder.

Intervention (second work program)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with schizophrenia spectrum disorder
• \- Patients with schizophrenia spectrum disorder and comorbid PTSD Diagnosis (DSM-5)

You may not qualify if:

• mental impairment (e.g. dementia)
• insufficient language comprehension
• non-compliance with appointments

Sponsors & Collaborators

• University of Konstanz: lead
• Centre for Psychiatry Reichenau: collaborator

Study Sites (1)

University of Konstanz, Psychotherapy Outpatient Clinic

Konstanz, 78464, Germany

Location

Related Publications (2)

• Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.

  PMID: 18172019 BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

  PMID: 3616518 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of psychological outpatient clinic, head of psychology at the research ward

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: November 5, 2018
• Study Start: January 1, 2018
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

DE (1)