NCT03402074

Brief Summary

This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

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

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

January 10, 2018

Last Update Submit

June 18, 2019

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (6)

  • Perceived Stress on Visual Analogue Scale

    VAS 0-100 mm

    5 weeks

  • Cohens Perceived Stress Scale 10 Items

    5 weeks

  • Likert-Skala

    about stressreduction

    5 weeks

  • ADS-K (Depression)

    5 weeks

  • General Self Efficacy Scale (Schwarzer)

    5 weeks

  • SF 36 Quality of Life

    5 weeks

Study Arms (1)

Group Hypnosis

EXPERIMENTAL

5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home

Behavioral: Group hypnosis

Interventions

Group hypnosisBEHAVIORAL

5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork

Group Hypnosis

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 70 years with subjective increased intensity of stress in the last four weeks on the visual analogue scale rated between 40 -100 mm (VAS 0 - 100 mm)
  • Ability to consent and sign declaration of informed consent

You may not qualify if:

  • Current or planned participation in a stress management program 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)

Hochschulambulanz für Naturheilkunde

Berlin, Germany

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

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

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

November 1, 2017

Primary Completion

February 15, 2018

Study Completion

December 31, 2018

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

DE(1)