DepressionNCT03869424
Influence of Expectations on Rumination
A study of Depression, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2019to 14 Aug 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 in the last four weeks
- intake of illegal drugs in the last two weeks
- consumption of alcohol in the last twelve hours
Show all 12Show fewer
- students in medicine, pharmacy, or psychology
- completed studies in medicine, pharmacy or psychology
- current pregnancy or lactation
- cardio vascular disease
- kidney disease
- liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Expectations on Rumination: An Experimental Investigation
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.
Read the detailed description
Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.
- Conditions
- Depression
- Being tested
- Active Placebo labelled as antidepessant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Placebo labelled as antidepessantOther
Participants receive an active nasal spray that is in fact a placebo.
| 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 rumination. They take the nasal spray once in the laboratory. Receives: Other: Active Placebo labelled as antidepessant |
| No-treatment control group | No intervention | Participants do not receive the nasal spray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
German questionnaire of 10 Items, e.g.: "I get lost in ruminative thoughts.", "I am present in this situation.", "My thoughts are focused on the past.".All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).
Measured: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
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: At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start27 May 2019
- Primary completion31 Jul 2019
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- 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
- NCT03869424
- Sponsor's protocol ID
- 2019-05k
- Status last verified
- Aug 2019
- First submitted
- 8 Mar 2019
- Last updated
- 16 Aug 2019
- 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 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Expectations on Rumination: An Experimental Investigation
- ClinicalTrials.gov ID
- NCT03869424
- Acronym / sponsor ID
- 2019-05k
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 11 Mar 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.
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.
Detailed description
Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Expectations Group | Experimental | Other: Active Placebo labelled as antidepessantParticipants receive a nasal spray that is in fact a placebo. However, they are told that it protects from rumination. They take the nasal spray once in the laboratory. |
| No-treatment control group | No intervention | –Participants do not receive the nasal spray. |
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 (12 listed)
- mental disorders
- allergic to capsaicin
- allergic to sesame oil
- intake of psychopharmacological drugs in the last four weeks
- 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 |
|---|---|---|
| Active Placebo labelled as antidepessantParticipants receive an active nasal spray that is in fact a placebo. | Other | Positive Expectations Group |
Primary outcome
Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
Time frame: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
German questionnaire of 10 Items, e.g.: "I get lost in ruminative thoughts.", "I am present in this situation.", "My thoughts are focused on the past.".All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).
Change in Positive and Negative Affect Schedule (PANAS-X)
Time frame: At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 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).
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.
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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 Depression, 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 12 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 State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung) (time frame: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.). The study lists 2 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 16 Aug 2019.