CompletedNot Applicable

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

Germany10 participantsStarted 2018-01-01

Plain-language 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. 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. 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PTSD symptom severity (PCL-5)

Timeframe: 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

Timeframe: 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)

Timeframe: 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

Timeframe: 1st and 2nd work program: at baseline.

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

Timeframe: 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

Trial details

NCT IDNCT03730831

SponsorUniversity of Konstanz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-24

View on ClinicalTrials.gov More Schizophrenia Spectrum Disorder trials