Hypnotherapy to Improve Coping With Stress

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

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

Study Overview

• Status: Completed
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: Hypnosis; Behavioral: Health education

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite University Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: HYPNOSTRESS2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No