Hypnotherapy to Improve Coping With Stress

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

Official Title
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A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: Hypnosis
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypnosis + health education<br>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<br>* 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.<br>|
| Other: Health education alone<br>Patients receive a health education booklet to improve coping with stress | Behavioral: Health education<br>* Participants receive a health education booklet on improving coping with stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 weeks | 
| 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. | 5 weeks, 12 weeks | 
| Stress reduction on Likert Scale | Stress rating on a Likert Scale | 5 weeks, 12 weeks | 
| Allgemeine Depressionsskala (ADS-K) | Hautzinger M, Bailer M, Hofmeister D, Keller F. (2012). Allgemeine Depressionsskala (ADS) (2. Aufl.). Göttingen: Hogrefe. | 5 weeks, 12 weeks | 
| 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. | 5 weeks, 12 weeks | 
| SF 36 Quality of Life | Bullinger M, Kirchberger I: SF-36: Fragebogen zum Gesundheitszustand, Hogrefe, Göttingen, Germany, 1998. | 5 weeks, 12 weeks |