Non-deceptive Application of Placebos in Insomnia (NAP)

Philipps University

Status: Completed

Conditions: Insomnia

Treatments: Other: Film sequence; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03616652

2017-43k

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

Non-deceptive placebo group (additional information)

Experimental group

Description:

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.

Treatment:

Other: Film sequence

Other: Film sequence

Drug: Placebo

Non-deceptive placebo group (no additional information)

Placebo Comparator group

Description:

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.

Treatment:

Other: Film sequence

Other: Film sequence

Drug: Placebo