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Hypnotherapy to Improve Coping With Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525093
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany

Brief Summary:
This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Hypnosis Behavioral: Health education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Active Comparator: Hypnosis + health education
5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home plus health education booklet on coping with stress
Behavioral: Hypnosis

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.


Health education alone
Patients receive a health education booklet to improve coping with stress
Behavioral: Health education
Participants receive a health education booklet on improving coping with stress.




Primary Outcome Measures :
  1. Perceived Stress on Visual Analogue Scale [ Time Frame: 5 weeks ]
    Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)


Secondary Outcome Measures :
  1. Perceived Stress on Visual Analogue Scale [ Time Frame: 12 weeks ]
    Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)

  2. Cohens Perceived Stress Scale 10 Items [ Time Frame: 5 weeks, 12 weeks ]
    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.

  3. Stress reduction on Likert Scale [ Time Frame: 5 weeks, 12 weeks ]
    Stress rating on a Likert Scale

  4. Allgemeine Depressionsskala (ADS-K) [ Time Frame: 5 weeks, 12 weeks ]
    Hautzinger M, Bailer M, Hofmeister D, Keller F. (2012). Allgemeine Depressionsskala (ADS) (2. Aufl.). Göttingen: Hogrefe.

  5. General Self Efficacy Scale (Schwarzer) [ Time Frame: 5 weeks, 12 weeks ]
    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.

  6. SF 36 Quality of Life [ Time Frame: 5 weeks, 12 weeks ]
    Bullinger M, Kirchberger I: SF-36: Fragebogen zum Gesundheitszustand, Hogrefe, Göttingen, Germany, 1998.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525093


Locations
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Germany
Charité University Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benno Brinkhaus, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03525093    
Other Study ID Numbers: HYPNOSTRESS2
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms