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Non-deceptive Application of Placebos in Insomnia (NAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616652
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center

Study Description
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Brief Summary:
The purpose of this study is to evaluate whether non-deceptive application of a placebo has an impact on subjective or objective sleep parameters in patients with primary insomnia.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Placebo Other: Film sequence Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Non-deceptive Application of Placebos in Insomnia
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-deceptive placebo group (additional information)
Participants receive a placebo pill and are told that it is placebo. They receive additional information about the power of placebo effects via a film sequence before they take the placebo.
 Drug: Placebo
Placebo pill

Other: Film sequence
The experimental group watches a film about the power of placebo effects.
Placebo Comparator: Non-deceptive placebo group (no additional information)
Participants receive a placebo pill and are told that it is placebo. They do not receive additional information about placebo effects. Instead, they watch a neutral film sequence about sleep.
 Drug: Placebo
Placebo pill

Other: Film sequence
The control group watches a film about sleep.


Outcome Measures
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Primary Outcome Measures :
  1. Self-reported Total Sleep Time [ Time Frame: change from baseline to 1 night after placebo intake ]
    assessed by sleep diary


Secondary Outcome Measures :
  1. Objective Sleep Efficiency [ Time Frame: change from baseline to 1 night after placebo intake ]
    assessed by actigraphy

  2. Objective Total Sleep Time [ Time Frame: change from baseline to 1 night after placebo intake ]
    assessed by actigraphy

  3. Objective Total Sleep Time [ Time Frame: change from baseline to 1 night after placebo intake ]
    assessed by polysomnography

  4. Objective Sleep Onset Latency [ Time Frame: change from baseline to 1 night after placebo intake ]
    assessed by polysomnography

  5. Self-reported Sleep Onset Latency [ Time Frame: change from baseline to 1 night after placebo intake ]
    assessed by sleep diary


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 years to 69 years
  • fluent in German language
  • provide written informed consent
  • ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion Criteria:

  • evidence for sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)
  • allergies to ingredients of placebo
  • patients scoring below 8 or above 21 on the Insomnia Severity Index
  • patients suffering from a mental disorder as verified by the SCID
  • patients suffering from an acute physical illness
  • nicotine consumption > 10 cigarettes/day
  • unwillingness to refrain from alcohol consumption throughout the study
  • change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization
  • intake of psychotropic drugs during the last 3 months prior to visit 1
  • currently pregnant (verified by urine pregnancy test) or lactating
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616652


Locations
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Germany
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Winfried Rief, Prof. Dr. Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg
More Information
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Responsible Party: Winfried Rief, Professor Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03616652    
Other Study ID Numbers: 2017-43k
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders