Trial document





This trial has been registered retrospectively.
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  DRKS00017653

Trial Description

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Title

Nocebo effects by providing informed consent in shared decision making? Not necessarily: A randomized pilot-trial.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Introduction
Providing detailed information about effects and side effects of a certain therapy is an integral component of shared decision making (SDM). In this study, we aimed to investigate whether a detailed imformation of the patient about possible side effects may induce nocebo (or placebo) effects. There is evidence for such an effect in other fields of medicine. Thus SDM would have, besides wanted effects (e.g. patient satisfaction with docter-patient-relationship), also unwanted effects.

Methods
We performed a single-blind randomized controlled pilot trial. N=51 patients diagnosed with a depressive disorder and troubled sleep, aged between 18 and 80 were recruited. Patients were randomized in an intervention group and a control group. In both groups patients received an open-label placebo pill instead of their usual sleep medication. In the intervention group, patients got a detailed information in terms of informed consent. In the control group, patients got only a short information.

Results/Discussion
There were no statistically significant differences between the groups concerning the main outcome (a visual analogue scale indicating impairment by side effects).

In this study we were not able to detect a correlation between a detailed information of the patient about unwanted side effects and the occurrence of nocebo (or placebo) effects. These findings oppose most publications on this topic and weakens arguments against a detailed information of the patient in terms of SDM.

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Brief Summary in Scientific Language

Introduction
Providing detailed information about effects and side effects of a certain therapy is an integral component of shared decision making (SDM). In this study, we aimed to investigate whether a detailed imformation of the patient about possible side effects may induce nocebo (or placebo) effects. There is evidence for such an effect in other fields of medicine. Thus SDM would have, besides wanted effects (e.g. patient satisfaction with docter-patient-relationship), also unwanted effects.

Methods
We performed a single-blind randomized controlled pilot trial. N=51 patients diagnosed with a depressive disorder and troubled sleep, aged between 18 and 80 were recruited. Patients were randomized in an intervention group and a control group. In both groups patients received an open-label placebo pill instead of their usual sleep medication. In the intervention group, patients got a detailed information in terms of informed consent. In the control group, patients got only a short information.

Results/Discussion
There were no statistically significant differences between the groups concerning the main outcome (a visual analogue scale indicating impairment by side effects).

In this study we were not able to detect a correlation between a detailed information of the patient about unwanted side effects and the occurrence of nocebo (or placebo) effects. These findings oppose most publications on this topic and weakens arguments against a detailed information of the patient in terms of SDM.

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Organizational Data

  •   DRKS00017653
  •   2019/08/30
  •   [---]*
  •   yes
  •   Approved
  •   5708/13, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F41.2 -  Mixed anxiety and depressive disorder
  •   F31 -  Bipolar affective disorder
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   For one night, patients receive an open-Label Placebo pill instead of their usual sleep medication. A detailed Information about effects and side effects in Terms of "informed consent" is perfomed.
  •   For one night, patients receive an open-Label Placebo pill instead of their usual sleep medication. A short Information in Terms of "simple consent" is perfomed.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Primary outcome is the amount of impairment by side effects through the new medication indicated on a visual analogue scale. Values vary from 1 (not at all) to 10 (a lot). The Rating takes place in the morning after the Placebo Administration.

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Secondary Outcome

Subjective Quality of Sleep. The rating takes place in the morning after the placebo administration using an in-house questionnaire that is routinely used in the somnological department of our clinic.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/12/02
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Diagnosis of a depressive disorder (ICD-10: F31, F32, F33 oder F41).
Documented sleep disorder.
Sleep medication.
Inpatient Treatment for at least 7 days.

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Exclusion Criteria

Not able to give written consent. Suicidiality.

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie des Klinikums rechts der Isar der TU München
    • Mr.  Dr.  Fabian  Holzhüter 
    • Ismaninger Straße 22
    • 81675  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie des Klinikums rechts der Isar der TU München
    • Mr.  Dr.  Fabian  Holzhüter 
    • Ismaninger Straße 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/17
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Trial Publications, Results and other Documents

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