Stress, PsychologicalHypnostressNCT03402074
Group Hypnosis for Stress Reduction
A study testing Group hypnosis in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects. 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?
- Group hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 31 Dec 2018
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Hypnosis for Stress Reduction - a Feasibility Study
This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.
Read the detailed description
In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including CDs/MP3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.
- Conditions
- Stress, Psychological
- Being tested
- Group hypnosis
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group hypnosisBehavioural
5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork
| Study group | Role | What they receive |
|---|---|---|
| Group Hypnosis | Experimental | 5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home Receives: Behavioral: Group hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress on Visual Analogue Scale
VAS 0-100 mm
Measured: 5 weeks
Cohens Perceived Stress Scale 10 Items
Measured: 5 weeks
Likert-Skala
about stressreduction
Measured: 5 weeks
ADS-K (Depression)
Measured: 5 weeks
General Self Efficacy Scale (Schwarzer)
Measured: 5 weeks
SF 36 Quality of Life
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Nov 2017
- Primary completion15 Feb 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT03402074
- Sponsor's protocol ID
- Hypnostress
- Acronym
- Hypnostress
- Status last verified
- Jun 2019
- First submitted
- 10 Jan 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Hypnosis for Stress Reduction - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03402074
- Acronym / sponsor ID
- Hypnostress / Hypnostress
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jan 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 feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.
Detailed description
In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including CDs/MP3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Hypnosis | Experimental | Behavioral: Group hypnosis5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Group hypnosis5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork | Behavioural | Group Hypnosis |
Primary outcome
Perceived Stress on Visual Analogue Scale
Time frame: 5 weeks
VAS 0-100 mm
Cohens Perceived Stress Scale 10 Items
Time frame: 5 weeks
Likert-Skala
Time frame: 5 weeks
about stressreduction
ADS-K (Depression)
Time frame: 5 weeks
General Self Efficacy Scale (Schwarzer)
Time frame: 5 weeks
SF 36 Quality of Life
Time frame: 5 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 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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 Group hypnosis 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 2 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 20 Jun 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2019.