Non-deceptive Application of Placebos in Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Drug: Placebo; Other: Film sequence

• Registration Number: NCT03616652
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Study Start: 2018-10-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-deceptive placebo group (no additional information)	Film sequence	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.
Non-deceptive placebo group (additional information)	Placebo	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.
Non-deceptive placebo group (additional information)	Film sequence	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.
Non-deceptive placebo group (no additional information)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Self-reported Total Sleep Time	change from baseline to 1 night after placebo intake	assessed by sleep diary

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg; 🇩🇪 Marburg, Germany