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Hypnotherapy to Improve Coping With Stress

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypnosis
Health education
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 65 years with increased perceived stress for at least 3 months
  • Perceived stress in the last week on the visual analog scale> 40 mm (VAS 0 - 100 mm)
  • Ability to consent and sign declaration of consent

Exclusion Criteria:

  • Current or planned participation in a stress management exercise 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

  • Charité University Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Hypnosis + health education

Health education alone

Arm Description

5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home plus health education booklet on coping with stress

Patients receive a health education booklet to improve coping with stress

Outcomes

Primary Outcome Measures

Perceived Stress on Visual Analogue Scale
Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)

Secondary Outcome Measures

Perceived Stress on Visual Analogue Scale
Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)
Cohens Perceived Stress Scale 10 Items
Cohen S, Kamarck T, and Mermelstein R, "A global measure of perceived stress," Journal of Health and Social Behavior, vol. 24, no. 4, pp. 385-396, 1983.
Stress reduction on Likert Scale
Stress rating on a Likert Scale
Allgemeine Depressionsskala (ADS-K)
Hautzinger M, Bailer M, Hofmeister D, Keller F. (2012). Allgemeine Depressionsskala (ADS) (2. Aufl.). Göttingen: Hogrefe.
General Self Efficacy Scale (Schwarzer)
Schwarzer R, Jerusalem M. (Hrsg.). Skalen zur Erfassung von Lehrer- und Schülermerkmalen: Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin: Freie Universität Berlin, 1999.
SF 36 Quality of Life
Bullinger M, Kirchberger I: SF-36: Fragebogen zum Gesundheitszustand, Hogrefe, Göttingen, Germany, 1998.

Full Information

First Posted
April 23, 2018
Last Updated
January 30, 2019
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03525093
Brief Title
Hypnotherapy to Improve Coping With Stress
Official Title
A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
January 30, 2019 (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 controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis + health education
Arm Type
Active Comparator
Arm Description
5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home plus health education booklet on coping with stress
Arm Title
Health education alone
Arm Type
Other
Arm Description
Patients receive a health education booklet to improve coping with stress
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
5 session of group hypnosis, each 90 minutes, to reduce subjective levels of stress, improve coping with stress. Additional audiotapes of hypnosis sessions as homework. Participants receive a health education booklet on improving coping with stress.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Participants receive a health education booklet on improving coping with stress.
Primary Outcome Measure Information:
Title
Perceived Stress on Visual Analogue Scale
Description
Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Perceived Stress on Visual Analogue Scale
Description
Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)
Time Frame
12 weeks
Title
Cohens Perceived Stress Scale 10 Items
Description
Cohen S, Kamarck T, and Mermelstein R, "A global measure of perceived stress," Journal of Health and Social Behavior, vol. 24, no. 4, pp. 385-396, 1983.
Time Frame
5 weeks, 12 weeks
Title
Stress reduction on Likert Scale
Description
Stress rating on a Likert Scale
Time Frame
5 weeks, 12 weeks
Title
Allgemeine Depressionsskala (ADS-K)
Description
Hautzinger M, Bailer M, Hofmeister D, Keller F. (2012). Allgemeine Depressionsskala (ADS) (2. Aufl.). Göttingen: Hogrefe.
Time Frame
5 weeks, 12 weeks
Title
General Self Efficacy Scale (Schwarzer)
Description
Schwarzer R, Jerusalem M. (Hrsg.). Skalen zur Erfassung von Lehrer- und Schülermerkmalen: Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin: Freie Universität Berlin, 1999.
Time Frame
5 weeks, 12 weeks
Title
SF 36 Quality of Life
Description
Bullinger M, Kirchberger I: SF-36: Fragebogen zum Gesundheitszustand, Hogrefe, Göttingen, Germany, 1998.
Time Frame
5 weeks, 12 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 65 years with increased perceived stress for at least 3 months Perceived stress in the last week on the visual analog scale> 40 mm (VAS 0 - 100 mm) Ability to consent and sign declaration of consent Exclusion Criteria: Current or planned participation in a stress management exercise 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
Charité University Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33187503
Citation
Fisch S, Trivakovic-Thiel S, Roll S, Keller T, Binting S, Cree M, Brinkhaus B, Teut M. Group hypnosis for stress reduction and improved stress coping: a multicenter randomized controlled trial. BMC Complement Med Ther. 2020 Nov 13;20(1):344. doi: 10.1186/s12906-020-03129-6.
Results Reference
derived

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Hypnotherapy to Improve Coping With Stress

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