Stress, PsychologicalNCT03525093
Hypnotherapy to Improve Coping With Stress
A study testing Hypnosis and Health education in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Hypnosis and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stress, Psychological
- Being tested
- Hypnosis, Health education
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
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 educationBehavioural
Participants receive a health education booklet on improving coping with stress.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Hypnosis |
| Health education alone | Other | Patients receive a health education booklet to improve coping with stress Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 weeks
Secondary outcomes (6)
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)
Measured: 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.
Measured: 5 weeks, 12 weeks
Stress reduction on Likert Scale
Stress rating on a Likert Scale
Measured: 5 weeks, 12 weeks
Allgemeine Depressionsskala (ADS-K)
Hautzinger M, Bailer M, Hofmeister D, Keller F. (2012). Allgemeine Depressionsskala (ADS) (2. Aufl.). Göttingen: Hogrefe.
Measured: 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.
Measured: 5 weeks, 12 weeks
SF 36 Quality of Life
Bullinger M, Kirchberger I: SF-36: Fragebogen zum Gesundheitszustand, Hogrefe, Göttingen, Germany, 1998.
Measured: 5 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start3 May 2018
- Primary completion30 Oct 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525093
- Sponsor's protocol ID
- HYPNOSTRESS2
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38708017Fisch 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.
PubMed 33187503
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial
- ClinicalTrials.gov ID
- NCT03525093
- Acronym / sponsor ID
- HYPNOSTRESS2
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis + health education | Active comparator | Behavioral: Hypnosis5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home plus health education booklet on coping with stress |
| Health education alone | Other | Behavioral: Health educationPatients receive a health education booklet to improve coping with stress |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis5 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. | Behavioural | Hypnosis + health education |
| Health educationParticipants receive a health education booklet on improving coping with stress. | Behavioural | Health education alone |
Primary outcome
Perceived Stress on Visual Analogue Scale
Time frame: 5 weeks
Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)
6 secondary outcomes
Perceived Stress on Visual Analogue Scale
Time frame: 12 weeks
Cohens Perceived Stress Scale 10 Items
Time frame: 5 weeks, 12 weeks
Stress reduction on Likert Scale
Time frame: 5 weeks, 12 weeks
Allgemeine Depressionsskala (ADS-K)
Time frame: 5 weeks, 12 weeks
General Self Efficacy Scale (Schwarzer)
Time frame: 5 weeks, 12 weeks
SF 36 Quality of Life
Time frame: 5 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Derived from this study: PubMed 38708017Siewert 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.
- Derived from this study: PubMed 33187503Fisch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and Health education in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress on Visual Analogue Scale (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03525093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.