Non-deceptive Application of Placebos in Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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Non-deceptive Application of Placebos in Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Placebo
* Other: Film sequence
* Other: Film sequence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-deceptive placebo group (additional information)<br>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<br>* Placebo pill<br>Other: Film sequence<br>* The experimental group watches a film about the power of placebo effects.<br>|
| Placebo Comparator: Non-deceptive placebo group (no additional information)<br>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<br>* Placebo pill<br>Other: Film sequence<br>* The control group watches a film about sleep.<br>|

What is the study measuring?
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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 |