Non-deceptive Application of Placebos in Insomnia

NCT ID: NCT03616652

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-01-31

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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo pill

Film sequence

Intervention Type OTHER

The experimental group watches a film about the power of placebo effects.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill

Film sequence

Intervention Type OTHER

The control group watches a film about sleep.

Interventions

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Placebo

Placebo pill

Intervention Type DRUG

Film sequence

The experimental group watches a film about the power of placebo effects.

Intervention Type OTHER

Film sequence

The control group watches a film about sleep.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Winfried Rief

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Winfried Rief, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg

Locations

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Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2017-43k

Identifier Type: -

Identifier Source: org_study_id

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