Coercive MeasuresNCT03512925
Effects of a Standardized Post-coercion Review Session.
A study testing Standardized debriefing session of coercive measures in people with Coercive Measures, run by Charite University, Berlin, Germany at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coercive Measures
- What is being tested?
- Standardized debriefing session of coercive measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Nov 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent
- Hospital stay < 24h
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Vivantes Klinikum am Urban
Berlin, 10967
Vivantes Wenckebach-Klinikum
Berlin, 12099
Vivantes Klinikum Neukölln
Berlin, 12351
Alexianer Krankenhaus Hedwigshöhe
Berlin, 12526
St. Joseph Krankenhaus Weißensee
Berlin, 13088
Psychiatrische Universitätsklink der Charité - SHK
Mitte, State of Berlin, 10115
About this study
Official title: Effects of a Standardized Post-coercion Review Session on Objective and Perceived Coercion
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.
Read more
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.
Read the detailed description
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
- Coercive Measures
- Being tested
- Standardized debriefing session of coercive measures
- Keywords
- Coercion, Post-coercion review, Mental health, Seclusion, Mechanical restraint
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized debriefing session of coercive measuresOther
Debriefing session following the developed guidelines including setting and themes.
| Study group | Role | What they receive |
|---|---|---|
| Standardized post-coercion review | Experimental | 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. Receives: Other: Standardized debriefing session of coercive measures |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective coercive measures
Number of coercive measures (seclusion, restraint, forced medication)
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Secondary outcomes (6)
Subjective experience of coercion (1)
Subjective experience coercion assessed by the German version of the Perceived Coercion Subscale (PCS) of the MacArthur Admission Experience Survey (AES). The AES comprises 16 dichotomous items (yes-no answers) divided in 4 subscales. The PCS comprises 5 items. A higher score (range 0-5) indicates a high level of perceived coercion.
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Subjective experience of coercion (2)
Subjective experience coercion assessed by the Coercion Ladder (CL). The CL is an analog scale ranging from 1 to 10 and assessing the level pf perceived coercion. Higher values indicate a higher level of perceived coercion.
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Subjective experience of coercion (3)
Subjective experience coercion assessed by the German version of the Coercion Experience Scale (CES). The CES is a scale used to measure the impact of coercive measures. It comprises 29 items related to perceived stressors during a coercive intervention with a 5-point Likert-scale. A total score is used with higher values indicating higher perceived coercion.
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Quality of the therapeutic relationship
Evaluation of the quality of the therapeutic relationship assessed by the German version of the Work Alliance Inventory-Short Form (WAI-SR). The WAI comprises 12 items divided into 3 subclass (goal, task, bond). each subscale comprises 4 items with a 5-point Likert-scale. The score range for each subscale ranges from 5 to 20. Higher scores indicate a better therapeutic alliance.
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Post-traumatic symptoms (1)
Development of post-traumatic symptoms assessed by the German version of the Peri-Traumatic Distress Inventory (PDI). The PDI assesses the reactions during the traumatic event. It comprises 13 items with a 0-4 Likert-scale. Scores of all items are summed up and so the total score ranges from 0 to 52. A score higher than 26 indicates a high risk of developing a post traumatic stress disorder.
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Post-traumatic symptoms (2)
Development of post-traumatic symptoms assessed by the German version of the Impact of Events Scale Revised (IES-R). The IES-R comprises 22 items with a Likert-scale ranging from 0 to 5. Items are divided into 3 sub scales (Intrusion (7 items), Avoidance (8 items), and Hyperarousal (7 items)). Scores for each sub scales are built by adding the answers to each item. Higher scores indicate a higher level of symptoms. The probability of post traumatic stress disorder (PTSD) is assessed using a formula developed by the German translators: X = (-0,02 x intrusion) + (0,07 x avoidance) + (0,15 x hyperarousal) - 4,36. Scores >0 indicate the probable presence of PTSD.
Measured: At the time of discharge from the hospital by every included patient, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Nov 2017
- Primary completion31 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coercive MeasuresStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants are randomly assigned either to the intervention arm (standardized post-coercion review session session) or to the Treatment-as-usual (TAU) arm.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Responsible party
- Principal investigator, Alexandre Wullschleger, Charite University, Berlin, Germany
- Investigators
- PD Dr. med. Montag, Study chair, CharitéDr. med. Mahler, Study chair, CharitéDr. med. Wullschleger, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512925
- Sponsor's protocol ID
- NBZM_MZ
- Status last verified
- Apr 2020
- First submitted
- 30 Jan 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33231771
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Standardized Post-coercion Review Session on Objective and Perceived Coercion
- ClinicalTrials.gov ID
- NCT03512925
- Acronym / sponsor ID
- NBZM_MZ
- Conditions
- Coercive Measures
- Keywords
- Coercion, Post-coercion review, Mental health, Seclusion, Mechanical restraint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants are randomly assigned either to the intervention arm (standardized post-coercion review session session) or to the Treatment-as-usual (TAU) arm.
| Arm | Type | Receives |
|---|---|---|
| Standardized post-coercion review | Experimental | Other: Standardized debriefing session of coercive measuresIntervention: 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Hospital stay < 24h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized debriefing session of coercive measuresDebriefing session following the developed guidelines including setting and themes. | Other | Standardized post-coercion review |
Primary outcome
Objective coercive measures
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Number of coercive measures (seclusion, restraint, forced medication)
6 secondary outcomes
Subjective experience of coercion (1)
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Subjective experience of coercion (2)
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Subjective experience of coercion (3)
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Quality of the therapeutic relationship
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Post-traumatic symptoms (1)
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Post-traumatic symptoms (2)
Time frame: At the time of discharge from the hospital by every included patient, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 33231771Wullschleger 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PD Dr. med. Montag study chair
Charité
Dr. med. Mahler study chair
Charité
Dr. med. Wullschleger principal investigator
Charité
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized debriefing session of coercive measures in people with Coercive Measures, run by Charite University, Berlin, Germany at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective coercive measures (time frame: At the time of discharge from the hospital by every included patient, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.