Non-deceptive Application of Placebos in Insomnia | NCT03616652

Studies
Non-deceptive Application of Placebos in Insomnia

NCT03616652

Sponsor

Philipps University Marburg

Status

Completed

Last Update Posted

Apr 13, 2021Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Insomnia

Interventions

Placebo
Film sequence
Film sequence

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Jan 31, 2020Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Jul 20, 2018

First Submission Date that Met QC Criteria

Aug 3, 2018

First Posted Date

Aug 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2021

Last Update Posted Date

Apr 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo pill	Non-deceptive placebo group (additional information) Non-deceptive placebo group (no additional information)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported Total Sleep Time	assessed by sleep diary	change from baseline to 1 night after placebo intake

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Winfried Rief, Prof. Dr.	Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg		Marburg		35032	Germany

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided