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Group Hypnosis for Stress Reduction (Hypnostress)

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Group hypnosis
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hochschulambulanz für Naturheilkunde

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Hypnosis

Arm Description

5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 10, 2018
Last Updated
June 18, 2019
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03402074
Brief Title
Group Hypnosis for Stress Reduction
Acronym
Hypnostress
Official Title
Group Hypnosis for Stress Reduction - a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Hypnosis
Arm Type
Experimental
Arm Description
5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home
Intervention Type
Behavioral
Intervention Name(s)
Group hypnosis
Intervention Description
5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork
Primary Outcome Measure Information:
Title
Perceived Stress on Visual Analogue Scale
Description
VAS 0-100 mm
Time Frame
5 weeks
Title
Cohens Perceived Stress Scale 10 Items
Time Frame
5 weeks
Title
Likert-Skala
Description
about stressreduction
Time Frame
5 weeks
Title
ADS-K (Depression)
Time Frame
5 weeks
Title
General Self Efficacy Scale (Schwarzer)
Time Frame
5 weeks
Title
SF 36 Quality of Life
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hochschulambulanz für Naturheilkunde
City
Berlin
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Group Hypnosis for Stress Reduction

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