Psycho-biological treatment effects of trauma-focused art therapy in patients with psychological and physical trauma consequences
Organizational Data
- DRKS-ID:
- DRKS00022989
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2020-09-08
- Last update in DRKS:
- 2020-09-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
MALT!
URL of the study
No Entry
Brief summary in lay language
The study examines the psychological and biological stress reaction of patients directly after a stressful life event. The aim is to examine, how patients react to a stress stimulus and to what extent art therapy can influence this reaction and reduce the probability of post-traumatic stress disorder
Brief summary in scientific language
The study examines the psychological and biological stress reaction of patients directly after a stressful life event. It will be examined how patients react to an external stress stimulus and to what extent an art therapy offer after the traumatic event influences this reaction and reduces the probability of occurrence of post-traumatic stress disorder.
Health condition or problem studied
- ICD10:
- F43.0 - Acute stress reaction
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Art Therapy Intervention The patients receive art therapy over 8 sessions in the course of approx. 3 months and will then be invited for a follow-up examination
- Arm 2:
- Watchful Waiting Control The patients do not receive an art therapy offer and are invited for a follow-up examination after about 3 months.
Endpoints
- Primary outcome:
- The primary objective is the severity of posttraumatic stress symptoms after the intervention, measured with the revised version of the Impact of Events Scale (IES-R) (Maercker & Schützwohl, 1998; Weiss & Marmar, 1997) and the German version of the Posttraumatic Diagnostic Survey (PDS)(Ehlers et al., 1996).
- Secondary outcome:
- Secondary biological targets are neuroendocrine and immunological stress reactivity (measured by cortisol and α-amylase in saliva, and interleukin (IL)-6 and IL-10 in plasma), stress-related DNA damage in single cells in the form of single- and double-strand breaks, and their metabolites (including nitrotyrosine/HO-1/iNOS) by exposure to stress-related radical formation. Secondary psychicological targets are depression and post-traumatic growth. Translated with www.DeepL.com/Translator (free version)
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Factorial
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Klinikum Nürnberg Nürnberg
Recruitment period and number of participants
- Planned study start date:
- 2020-09-27
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 128
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- 50 Years
- Additional Inclusion Criteria:
- Recruitment of patients after potentially traumatizing, critical events that have an increased risk of developing post-traumatic stress disorder Critical events are defined as: a) miscarriage or stillbirth b) Incisive cardiac event (e.g. myocardial infarction, resuscitation after cardiac event, aortic dissection) c) Serious accident (e.g. traffic accident)
Exclusion Criteria
- Male sex - Acute addiction - Acute suicidal tendency - Mental disorders that require permanent medication - Chronic inflammatory diseases with anti-inflammatory medication - Dementia - Insufficient knowledge of the german language - Non-accessibility of the Klinikum Nürnberg from your place of residence (for outpatient therapy sessions)
Addresses
Primary Sponsor
- Address:
- Ärztliche Leitung der Klinik fürPsychosomatische Medizin und PsychotherapieKlinikum NürnbergProf. Dr. med Christiane WallerProf.-Ernst-Nathan-Straße 190419 NürnbergGermany
- Telephone:
- 0911 398 - 2839
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-nuernberg.de/DE/ueber_uns/Fachabteilungen_KN/kliniken/psychosomatik/MA_Waller.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Ärztliche Leitung der Klinik für Psychosomatische Medizin und PsychotherapieKlinikum NürnbergProf. Dr. med Christiane WallerProf.-Ernst-Nathan-Straße 190419 NürnbergGermany
- Telephone:
- 0911 398 - 2839
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-nuernberg.de/DE/ueber_uns/Fachabteilungen_KN/kliniken/psychosomatik/MA_Waller.html
Contact for Public Queries
- Address:
- Ärztliche Leitung der Klinik für Psychosomatische Medizin und PsychotherapieKlinikum NürnbergProf. Dr. med Christiane WallerProf.-Ernst-Nathan-Straße 190419 NürnbergGermany
- Telephone:
- 0911 398 - 2839
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-nuernberg.de/DE/ueber_uns/Fachabteilungen_KN/kliniken/psychosomatik/MA_Waller.html
Principal Investigator
- Address:
- Ärztliche Leitung der Klinik für Psychosomatische Medizin und PsychotherapieKlinikum NürnbergProf. Dr. med Christiane WallerProf.-Ernst-Nathan-Straße 190419 NürnbergGermany
- Telephone:
- 0911 398 - 2839
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-nuernberg.de/DE/ueber_uns/Fachabteilungen_KN/kliniken/psychosomatik/MA_Waller.html
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- STAEDTLER StiftungMoosäckerstraße 390427 NürnbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.staedtler.com/de/de/stiftung/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Erlangen-NürnbergKrankenhausstr. 1291054 ErlangenGermany
- Telephone:
- +40-9131-8522270
- Fax:
- +49-9131-8526021
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-05-03
- Ethics committee number:
- 121_19 B
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-05-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry