Effects of a Standardized Post-coercion Review Session.

NCT ID: NCT03512925

Last Updated: 2020-04-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-06-30

Brief Summary

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The present study aims at exploring the impact of a standardized post-coercion review session of coercive measures that took place in the psychiatric inpatient setting in reducing the use of coercive measures and the subjective perception of coercion. It is well known that coercive measures have a major negative impact on the health, well-being and the course of treatment of patients suffering from mental health issues. Many interventions have been implemented in the last years to reduce the use of coercion and limit its consequences.

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.

Detailed Description

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The present study aims at exploring the impact of a standardized post-coercion review session of coercive measures that took place in the psychiatric inpatient setting in reducing the use of coercive measures and the subjective perception of coercion. It is well known that coercive measures have a major negative impact on the health, well-being and the course of treatment of patients suffering from mental health issues. Many interventions have been implemented in the last years to reduce the use of coercion and limit its consequences.

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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Coercive Measures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants are randomly assigned either to the intervention arm (standardized post-coercion review session session) or to the Treatment-as-usual (TAU) arm.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type EXPERIMENTAL

Standardized debriefing session of coercive measures

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inpatient
* 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

* Inability to provide informed consent
* Hospital stay \< 24h
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Ministry of Health, Germany

OTHER_GOV

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Wullschleger

Principal Investigator

Responsibility Role 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

Site Status

Vivantes Klinikum am Urban

Berlin, , Germany

Site Status

Vivantes Wenckebach-Klinikum

Berlin, , Germany

Site Status

Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status

Alexianer Krankenhaus Hedwigshöhe

Berlin, , Germany

Site Status

St. Joseph Krankenhaus Weißensee

Berlin, , Germany

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 33231771 (View on PubMed)

Other Identifiers

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NBZM_MZ

Identifier Type: -

Identifier Source: org_study_id

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