- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402074
Group Hypnosis for Stress Reduction (Hypnostress)
June 18, 2019 updated by: Benno Brinkhaus, Charite University, Berlin, Germany
Group Hypnosis for Stress Reduction - a Feasibility Study
This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany
- Hochschulambulanz für Naturheilkunde
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Hypnosis
5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home
|
5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation.
Additional auditapes of hypnosis sessions as hoemwork
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress on Visual Analogue Scale
Time Frame: 5 weeks
|
VAS 0-100 mm
|
5 weeks
|
Cohens Perceived Stress Scale 10 Items
Time Frame: 5 weeks
|
5 weeks
|
|
Likert-Skala
Time Frame: 5 weeks
|
about stressreduction
|
5 weeks
|
ADS-K (Depression)
Time Frame: 5 weeks
|
5 weeks
|
|
General Self Efficacy Scale (Schwarzer)
Time Frame: 5 weeks
|
5 weeks
|
|
SF 36 Quality of Life
Time Frame: 5 weeks
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
February 15, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
January 10, 2018
First Submitted That Met QC Criteria
January 10, 2018
First Posted (Actual)
January 18, 2018
Study Record Updates
Last Update Posted (Actual)
June 20, 2019
Last Update Submitted That Met QC Criteria
June 18, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypnostress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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