Effects of a Standardized Post-coercion Review Session.
NCT ID: NCT03512925
Last Updated: 2020-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2017-11-01
2019-06-30
Brief Summary
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The investigators developed a standardized post-coercion review intervention. This session takes place as soon as possible after the concerned coercive measure and is moderated by a member of staff who has not been involved in the use of coercion. Other persons involved are the patient, a staff member who took the decision leading to the use of the coercive measure, and a one of the patient's relatives.
Hypothesis is that the use of this standardized intervention can reduce the use of subsequent coercive measures and level of perceived coercion, prevent the development of post-traumatic symptoms, help preserving a trustful therapeutic relationship and positively change the attitude of staff regarding the use of coercion. This intervention has been proven to be well accepted by patients and staff members in a previous pilot study.
The present study is designed as a randomised-controlled study investigating the effect of post-coercion review.
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Detailed Description
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The investigators developed a standardized post-coercion review intervention. This session takes place as soon as possible after the concerned coercive measure and is moderated by a member of staff who has not been involved in the use of coercion. Other persons involved are the patient, a staff member who took the decision leading to the use of the coercive measure, and a one of the patient's relatives. The guidelines define important themes and questions that should be addressed during the review session. These guidelines have been developed with the help of psychiatrists, nurses and a peer worker.
Hypothesis is that the use of this standardized intervention can reduce the use of subsequent coercive measures and level of perceived coercion, prevent the development of post-traumatic symptoms, help preserving a trustful therapeutic relationship and positively change the attitude of staff regarding the use of coercion. This intervention has been proven to be well accepted by patients and staff members in a previous pilot study. The methods combine quantitative and qualitative evaluations.
The present study is designed as a randomised-controlled study investigating the effect of post-coercion review.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standardized post-coercion review
Intervention: Standardized post-coercion review session. Patients allocated to this arm receive a standardized post-coercion review of the coercive measure they experienced using the developed guidelines.
Standardized debriefing session of coercive measures
Debriefing session following the developed guidelines including setting and themes.
Control group
Patients allocated to this arm are treated following usual standards and routine. This might include some form of post-coercion review that doesn't follow the developed standardized guidelines.
No interventions assigned to this group
Interventions
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Standardized debriefing session of coercive measures
Debriefing session following the developed guidelines including setting and themes.
Eligibility Criteria
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Inclusion Criteria
* Subject to coercive measure (seclusion, restraint, forced medication)
* Diagnosis of a psychotic disorder (ICD-10: F1x.5, F2x, F31.x).
* Written and informed consent.
Exclusion Criteria
* Hospital stay \< 24h
18 Years
ALL
No
Sponsors
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Federal Ministry of Health, Germany
OTHER_GOV
Charite University, Berlin, Germany
OTHER
Responsible Party
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Alexandre Wullschleger
Principal Investigator
Principal Investigators
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PD Dr. med. Montag
Role: STUDY_CHAIR
Charité
Dr. med. Mahler
Role: STUDY_CHAIR
Charité
Dr. med. Wullschleger
Role: PRINCIPAL_INVESTIGATOR
Charité
Locations
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Psychiatrische Universitätsklink der Charité - SHK
Mitte, State of Berlin, Germany
Vivantes Klinikum am Urban
Berlin, , Germany
Vivantes Wenckebach-Klinikum
Berlin, , Germany
Vivantes Klinikum Neukölln
Berlin, , Germany
Alexianer Krankenhaus Hedwigshöhe
Berlin, , Germany
St. Joseph Krankenhaus Weißensee
Berlin, , Germany
Countries
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References
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Wullschleger A, Vandamme A, Mielau J, Renner L, Bermpohl F, Heinz A, Montag C, Mahler L. Effect of standardized post-coercion review session on symptoms of PTSD: results from a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2021 Sep;271(6):1077-1087. doi: 10.1007/s00406-020-01215-x. Epub 2020 Nov 24.
Other Identifiers
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NBZM_MZ
Identifier Type: -
Identifier Source: org_study_id
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