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Completed

NCT Number: NCT03512925

Effects of a Standardized Post-coercion Review Session.

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.

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Key information

Conditions

Coercive Measures Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatrische Universitätsklink der Charité - SHK, Mitte, State of Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized debriefing session of coercive measures

Other

Debriefing session following the developed guidelines including setting and themes.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. Subjective experience of coercion (3)

    Time frame: At the time of discharge from the hospital by every included patient, up to 6 months

    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.

  4. Quality of the therapeutic relationship

    Time frame: At the time of discharge from the hospital by every included patient, up to 6 months

    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.

  5. Post-traumatic symptoms (1)

    Time frame: At the time of discharge from the hospital by every included patient, up to 6 months

    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.

  6. Post-traumatic symptoms (2)

    Time frame: At the time of discharge from the hospital by every included patient, up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Federal Ministry of Health, Germany

Registry information

Official study title

Effects of a Standardized Post-coercion Review Session on Objective and Perceived Coercion

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 1, 2018
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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