Healthy ParticipantsNCT03607214
Longterm Effects of Expectations on Mood
A study of Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The study tries to identify whether positive expectations, induced with a placebo nasal-spray, have short- and longterm effects on participant's mood. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2018to 15 May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- fluent in German language
Who cannot join
- mental disorders
- allergic to capsaicin
- allergic to sesame oil
- intake of psychopharmacological drugs
- intake of illegal drugs in the last two weeks
- consumption of alcohol in the last twelve hours
- students in medicine, pharmacy, or psychology
- completed studies in medicine, pharmacy or psychology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longterm Effects of Expectations on Mood: An Experimental Investigation
The study tries to identify whether positive expectations, induced with a placebo nasal-spray, have short- and longterm effects on participant's mood.
Read the detailed description
Healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. They will randomly be assigned to the experimental group (taking the antidepressant which is in fact an active placebo) or the control group (not taking a placebo). Then participants watch a well established film sequence to induce sadness. Sadness is assessed before and after receiving the nasal spray and watching the film sequence. In the seven consecutive days the participant's mood is assessed each day, only the experimental group is taking the placebo each day. Afterwards participants will watch another sad film sequence and sadness will be assessed before and afterwards.
- Conditions
- Healthy Participants
- Being tested
- Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo nasal spray
Film Sequence
| Study group | Role | What they receive |
|---|---|---|
| Positive Expectations Group | Experimental | Participants receive a nasal spray that is in fact a placebo. However, they are told that it protects from experiencing negative emotions and generally improves their mood. They take the nasal spay in the laboratory and on seven consecutive days. Participants watch two film sequences that are supposed to induce sadness. Receives: Other: Placebo |
| No-treatment control group | No intervention | Participants do not receive the nasal spray. Participants watch two film sequences that are supposed to induce sadness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Affect Schedule (PANAS-X)
Items of PANAS-X: Sadness Score ("sad", "blue", "downhearted", "alone", "lonely") and Items "Surprised", "concentrating", "happy". All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).
Measured: Directly before and after watching the film sequence and on the following seven days, each assessment is taking four minutes, in total 36 minutes.
Secondary outcomes (1)
Coping with stress and daily hassles, general mood and concentration.
The following Items are developed by the authors and will also be rated on a visual analogue scale (VAS) from 0 to 10.
"How do you feel at the moment"? "How did you feel yesterday?" "How stress-resistent did you feel yesterday?" "How stress-resistant do you feel at the moment?"
Measured: On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Nov 2018
- Primary completion15 Apr 2019
- Study completion15 May 2019
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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Professor, Principal investigator, Philipps-Univeristy of Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607214
- Sponsor's protocol ID
- 2018-15k
- Status last verified
- Aug 2019
- First submitted
- 16 Jun 2018
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Effects of Expectations on Mood: An Experimental Investigation
- ClinicalTrials.gov ID
- NCT03607214
- Acronym / sponsor ID
- 2018-15k
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 31 Jul 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.
The study tries to identify whether positive expectations, induced with a placebo nasal-spray, have short- and longterm effects on participant's mood.
Detailed description
Healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. They will randomly be assigned to the experimental group (taking the antidepressant which is in fact an active placebo) or the control group (not taking a placebo). Then participants watch a well established film sequence to induce sadness. Sadness is assessed before and after receiving the nasal spray and watching the film sequence. In the seven consecutive days the participant's mood is assessed each day, only the experimental group is taking the placebo each day. Afterwards participants will watch another sad film sequence and sadness will be assessed before and afterwards.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Expectations Group | Experimental | Other: PlaceboParticipants receive a nasal spray that is in fact a placebo. However, they are told that it protects from experiencing negative emotions and generally improves their mood. They take the nasal spay in the laboratory and on seven consecutive days. Participants watch two film sequences that are supposed to induce sadness. |
| No-treatment control group | No intervention | –Participants do not receive the nasal spray. Participants watch two film sequences that are supposed to induce sadness. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy volunteers
- fluent in German language
Key exclusion criteria (8 listed)
- mental disorders
- allergic to capsaicin
- allergic to sesame oil
- intake of psychopharmacological drugs
- intake of illegal drugs in the last two weeks
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 |
|---|---|---|
| PlaceboPlacebo nasal spray Film Sequence | Other | Positive Expectations Group |
Primary outcome
Change in Positive and Negative Affect Schedule (PANAS-X)
Time frame: Directly before and after watching the film sequence and on the following seven days, each assessment is taking four minutes, in total 36 minutes.
Items of PANAS-X: Sadness Score ("sad", "blue", "downhearted", "alone", "lonely") and Items "Surprised", "concentrating", "happy". All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).
1 secondary outcome
Coping with stress and daily hassles, general mood and concentration.
Time frame: On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 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 16 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Winfried Rief, Professor principal investigator
Philipps-Univeristy of Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 2 inclusion and 8 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 16 Aug 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?
Change in Positive and Negative Affect Schedule (PANAS-X) (time frame: Directly before and after watching the film sequence and on the following seven days, each assessment is taking four minutes, in total 36 minutes.). 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 16 Aug 2019.