Non-deceptive Application of Placebos in Insomnia

NCT03616652 | Completed

• 1 other identifier: 2017-43k
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Self-reported Total Sleep Time

  assessed by sleep diary

  change from baseline to 1 night after placebo intake

Secondary Outcomes (5)

• Objective Sleep Efficiency

  change from baseline to 1 night after placebo intake

• Objective Total Sleep Time

  change from baseline to 1 night after placebo intake

• Objective Total Sleep Time

  change from baseline to 1 night after placebo intake

• Objective Sleep Onset Latency

  change from baseline to 1 night after placebo intake

• Self-reported Sleep Onset Latency

  change from baseline to 1 night after placebo intake

Study Arms (2)

Non-deceptive placebo group (additional information)

EXPERIMENTAL

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; Other: Film sequence

Non-deceptive placebo group (no additional information)

PLACEBO COMPARATOR

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; Other: Film sequence

Interventions

Placebo DRUG

Placebo pill

Non-deceptive placebo group (additional information); Non-deceptive placebo group (no additional information)

Film sequence OTHER

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

Non-deceptive placebo group (additional information)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, 35032, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Winfried Rief, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 6, 2018
• Study Start: October 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

DE (1)