Non-deceptive Application of Placebos in Insomnia (NAP)

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Placebo; Other: Film sequence; Other: Film sequence

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35032
    • Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Other: Film sequence; The control group watches a film about sleep.
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 experimental group watches a film about the power of placebo effects.; Other: Film sequence; The control group watches a film about sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Total Sleep Time	assessed by sleep diary	change from baseline to 1 night after placebo intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Sleep Efficiency	assessed by actigraphy	change from baseline to 1 night after placebo intake
Objective Total Sleep Time	assessed by actigraphy	change from baseline to 1 night after placebo intake
Objective Total Sleep Time	assessed by polysomnography	change from baseline to 1 night after placebo intake
Objective Sleep Onset Latency	assessed by polysomnography	change from baseline to 1 night after placebo intake
Self-reported Sleep Onset Latency	assessed by sleep diary	change from baseline to 1 night after placebo intake

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Prof. Dr., Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2017-43k

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No