Healthy ParticipantsNCT02848014
The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor
A study testing Writing task in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The purpose of the study is to determine whether a short psychological intervention aiming at optimizing expectations is able to foster positive emotions and whether an intervention inducing positive emotions is able improve participants' expectations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Writing task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to 30 Nov 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032
About this study
Official title: The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor on Subjective and Objective Stress Paramaters
The purpose of the study is to determine whether a short psychological intervention aiming at optimizing expectations is able to foster positive emotions and whether an intervention inducing positive emotions is able improve participants' expectations. Furthermore, the investigators will examine whether both interventions are effective in buffering the stress response after an acute stressor in a healthy sample compared to a control condition.
- Conditions
- Healthy Participants
- Being tested
- Writing task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing taskBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Expectation | Experimental | Participants are asked to think and write about ways how they can positively influence/control the stress during stress induction. They also can think of strategies they used in their past. The purpose of this arm is to improve participants' personal control expectations. Receives: Behavioral: Writing task |
| Emotion | Experimental | Participants in this group are asked to write a gratitude-letter to a person they want to thank. The purpose of this arm is to foster positive emotions. Receives: Behavioral: Writing task |
| Control | Active comparator | Participants in this group are asked to do a neutral writing task. The task is to write a protocol of yesterday's to-dos. Receives: Behavioral: Writing task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in personal control expectation (Item of the Brief IPQ)
Measured: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)
Secondary outcomes (4)
Change in emotions (PANAS)
Measured: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)
Subjective stress ratings
Questionnaire items
Measured: directly after completing the stress induction (approximately 50 minutes after baseline assessment; T2)
Change in Cortisol levels (saliva sample)
directly (T2), 15 min (T3) and 30 min (T4) after stress induction = 50 min, 65 min and 80 min after baseline assessment
Measured: Pre-intervention (baseline; T0) vs.Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction
Change in Alpha-Amylase levels (saliva sample)
directly (T2), 15 min (T3) and 30 min (T4) after stress induction = 50 min, 65 min and 80 min after baseline assessment
Measured: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Professor, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848014
- Sponsor's protocol ID
- 2016-08k
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor on Subjective and Objective Stress Paramaters
- ClinicalTrials.gov ID
- NCT02848014
- Acronym / sponsor ID
- 2016-08k
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
The purpose of the study is to determine whether a short psychological intervention aiming at optimizing expectations is able to foster positive emotions and whether an intervention inducing positive emotions is able improve participants' expectations. Furthermore, the investigators will examine whether both interventions are effective in buffering the stress response after an acute stressor in a healthy sample compared to a control condition.
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: Writing taskParticipants are asked to think and write about ways how they can positively influence/control the stress during stress induction. They also can think of strategies they used in their past. The purpose of this arm is to improve participants' personal control expectations. |
| Emotion | Experimental | Behavioral: Writing taskParticipants in this group are asked to write a gratitude-letter to a person they want to thank. The purpose of this arm is to foster positive emotions. |
| Control | Active comparator | Behavioral: Writing taskParticipants in this group are asked to do a neutral writing task. The task is to write a protocol of yesterday's to-dos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fluent in German language
Key exclusion criteria (5 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
- current intake of psychotropic medication
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 |
|---|---|---|
| Writing task | Behavioural | Control, Emotion, Expectation |
Primary outcome
Change in personal control expectation (Item of the Brief IPQ)
Time frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)
4 secondary outcomes
Change in emotions (PANAS)
Time frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)
Subjective stress ratings
Time frame: directly after completing the stress induction (approximately 50 minutes after baseline assessment; T2)
Change in Cortisol levels (saliva sample)
Time frame: Pre-intervention (baseline; T0) vs.Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction
Change in Alpha-Amylase levels (saliva sample)
Time frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction
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 6 Apr 2017.
Related trials for Healthy Participants
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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.
Winfried Rief, Professor 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 Writing task in people with Healthy Participants, 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 5 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 6 Apr 2017. 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 personal control expectation (Item of the Brief IPQ) (time frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)). 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 6 Apr 2017.