NCT03525093

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

April 23, 2018

Last Update Submit

January 30, 2019

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Perceived Stress on Visual Analogue Scale

    12 weeks

  • Cohens Perceived Stress Scale 10 Items

    5 weeks, 12 weeks

  • Stress reduction on Likert Scale

    5 weeks, 12 weeks

  • Allgemeine Depressionsskala (ADS-K)

    5 weeks, 12 weeks

  • General Self Efficacy Scale (Schwarzer)

    5 weeks, 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Hypnosis + health education

ACTIVE COMPARATOR

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

Health education alone

OTHER

Patients receive a health education booklet to improve coping with stress

Behavioral: Health education

Interventions

HypnosisBEHAVIORAL

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.

Hypnosis + health education
Health educationBEHAVIORAL

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

Health education alone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Berlin

Berlin, 10117, Germany

Location

Related Publications (2)

  • Siewert J, Teut M, Brinkhaus B, Fisch S, Kummer S. The relevance of outcome expectations in group hypnosis for stress reduction: a secondary analysis of a multicenter randomized controlled trial. Front Psychol. 2024 Apr 19;15:1363037. doi: 10.3389/fpsyg.2024.1363037. eCollection 2024.

    PMID: 38708017DERIVED

  • 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.

    PMID: 33187503DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 15, 2018

Study Start

May 3, 2018

Primary Completion

October 30, 2018

Study Completion

January 30, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

DE(1)