Psychological StressNCT04171154
Effects of Micro-Interventions on Stress Reactivity
A study testing Expectation and Acceptance in people with Psychological Stress and Physiological Stress, run by Philipps University Marburg at 1 site in Germany.
Trial summary
This study aims to investigate the effects of short, psychological interventions on bio-psychological stress responses after an acute stressor. The efficacy of two different approaches (expectation-bases vs. acceptance-based) will be compared to a control-group. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Physiological Stress
- What is being tested?
- Expectation and Acceptance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2019to 19 Oct 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- fluent in German language
Who cannot join
- chronic disease
- mental disease
- the evening before the day of the experiment until end of the experiment (the next day):
- caffeine, alcohol, intensive physical exercise, chewing gum
- acute hay fever
- current intake of psychotropic medication
Show all 9Show fewer
- current intake of orale contraceptives
- visual impairments
- heart conditions (self and close relatives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Brief, Psychological Interventions (Micro-Interventions) on the Individual Stress Reactivity
This study aims to investigate the effects of short, psychological interventions on bio-psychological stress responses after an acute stressor. The efficacy of two different approaches (expectation-bases vs. acceptance-based) will be compared to a control-group.
- Conditions
- Psychological Stress, Physiological Stress
- Being tested
- Expectation, Acceptance
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExpectationBehavioural
writing task
AcceptanceBehavioural
listening
| Study group | Role | What they receive |
|---|---|---|
| Expectation | Experimental | Participants are asked to think of three strength which have helped them in prior stressful events. They then have to think of ways how these strength may help them in future stressful situations, i.e. a test in this experiment. Receives: Behavioral: Expectation |
| Acceptance | Experimental | Participants listen to an audio-instruction on cognitive defusion. They shall observe the thoughts and feelings of stress and, with the help of the instruction, distance themselves from it. Receives: Behavioral: Acceptance |
| Control | No intervention | Participants wait for the stress-test to start. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective Stress Ratings
VAS (visual analogue scale)
Measured: at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes
Change in Cortisol Levels
saliva sample
Measured: at baseline (min. -37), after the intervention (min. -19), after the stressor (min. 0), recovery 1 (min. +15), recovery 2 (min. +30); in total 67 minutes
Changes in Heart-Rate-Variability (HRV)
electrocardiogram
Measured: during baseline (duration 10 minutes), during the stressor (duration 20 minutes), during recovery (duration 10 minutes); in total 40 minutes
Changes in Affect
VAS (visual analogue scale)
Measured: at baseline, after the stressor; in total 45 minutes
Secondary outcomes (2)
Self-Efficacy
questionnaire (self-efficacy scale; Schwarzer \& Jerusalem, 1999)
Measured: at baseline, after the recovery-phase; in total 55 minutes
Positivity
questionnaire (positivity scale; Caprara et al., 2012, König, 2012)
Measured: at baseline, after the recovery-phase; in total 55 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start15 Aug 2019
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Euteneuer, Prof. Dr., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171154
- Sponsor's protocol ID
- 2019-54k
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Brief, Psychological Interventions (Micro-Interventions) on the Individual Stress Reactivity
- ClinicalTrials.gov ID
- NCT04171154
- Acronym / sponsor ID
- 2019-54k
- Conditions
- Psychological Stress, Physiological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 20 Nov 2019 (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 study aims to investigate the effects of short, psychological interventions on bio-psychological stress responses after an acute stressor. The efficacy of two different approaches (expectation-bases vs. acceptance-based) will be compared to a control-group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expectation | Experimental | Behavioral: ExpectationParticipants are asked to think of three strength which have helped them in prior stressful events. They then have to think of ways how these strength may help them in future stressful situations, i.e. a test in this experiment. |
| Acceptance | Experimental | Behavioral: AcceptanceParticipants listen to an audio-instruction on cognitive defusion. They shall observe the thoughts and feelings of stress and, with the help of the instruction, distance themselves from it. |
| Control | No intervention | –Participants wait for the stress-test to start. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- fluent in German language
Key exclusion criteria (9 listed)
- chronic disease
- mental disease
- the evening before the day of the experiment until end of the experiment (the next day):
- caffeine, alcohol, intensive physical exercise, chewing gum
- acute hay fever
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 |
|---|---|---|
| Expectationwriting task | Behavioural | Expectation |
| Acceptancelistening | Behavioural | Acceptance |
Primary outcome
Change in Subjective Stress Ratings
Time frame: at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes
VAS (visual analogue scale)
Change in Cortisol Levels
Time frame: at baseline (min. -37), after the intervention (min. -19), after the stressor (min. 0), recovery 1 (min. +15), recovery 2 (min. +30); in total 67 minutes
saliva sample
Changes in Heart-Rate-Variability (HRV)
Time frame: during baseline (duration 10 minutes), during the stressor (duration 20 minutes), during recovery (duration 10 minutes); in total 40 minutes
electrocardiogram
Changes in Affect
Time frame: at baseline, after the stressor; in total 45 minutes
VAS (visual analogue scale)
2 secondary outcomes
Self-Efficacy
Time frame: at baseline, after the recovery-phase; in total 55 minutes
Positivity
Time frame: at baseline, after the recovery-phase; in total 55 minutes
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 2 Jul 2021.
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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.
Frank Euteneuer, Prof. Dr. principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expectation and Acceptance in people with Psychological Stress and Physiological Stress, run by Philipps University Marburg 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 1 inclusion and 9 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 2 Jul 2021. 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?
Change in Subjective Stress Ratings (time frame: at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes). The study lists 4 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 2 Jul 2021.