Group Hypnosis for Stress Reduction | NCT03402074

Studies
Group Hypnosis for Stress Reduction

NCT03402074

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jun 20, 2019Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Stress, Psychological

Interventions

Group hypnosis

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

Jun 2019

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

Nov 1, 2017Actual

Primary Completion Date

Feb 15, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jan 10, 2018

First Submission Date that Met QC Criteria

Jan 10, 2018

First Posted Date

Jan 18, 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

Jun 18, 2019

Last Update Posted Date

Jun 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benno Brinkhaus, Prof. Dr. med., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.

Detailed Description

In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including CDs/MP3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Hypnosis	Experimental	5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home	Behavioral: Group hypnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group hypnosis	Behavioral	5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perceived Stress on Visual Analogue Scale	VAS 0-100 mm	5 weeks
Cohens Perceived Stress Scale 10 Items		5 weeks
Likert-Skala	about stressreduction	5 weeks
ADS-K (Depression)		5 weeks
General Self Efficacy Scale (Schwarzer)		5 weeks
SF 36 Quality of Life		5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy or health-stable participants between 18 and 70 years with subjective increased intensity of stress in the last four weeks on the visual analogue scale rated between 40 -100 mm (VAS 0 - 100 mm)
Ability to consent and sign declaration of informed consent

Exclusion Criteria:

Current or planned participation in a stress management program within the next 17 weeks
Current use of psychotherapeutic treatment
presence of moderate or severe acute or chronic disease
presence of an acute or chronic mental disorder
Participation in a study within the last 2 months prior to enrollment
Lack of understanding of the German language

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hochschulambulanz für Naturheilkunde		Berlin			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided