Hypnotherapy to Improve Coping With Stress

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525093
• Other study ID #: HYPNOSTRESS2
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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
Participants receive a health education booklet on improving coping with stress.

Locations

Country	Name	City	State
Germany	Charité University Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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