Major Depressive DisorderEXPECD4NCT03780881
EXperimental Paradigm to Investigate Expectation Change in Depression 4
A study testing Expectation confirmation and Expectation disconfirmation in people with Major Depressive Disorder, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Research has shown that people with depressive symptoms maintain negative expectations even if they have positive experiences that contradict their expectations. Healthy people, however, change their expectations after unexpected positive experiences. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Expectation confirmation and Expectation disconfirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2018to 31 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of major depression
- at least 18 years old
- sufficient German language skills
- at least 18 years old
- sufficient German language skills
Who cannot join
- participation in previous studies on changes in expectations
- participation in previous studies on changes in expectations
- current diagnosis of any mental disorder
- diagnosis of major depression in the past
- currently receiving psychotherapeutic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Worse Than Expected - Differences Between Healthy and Depressed People in Processing Unexpectedly Negative Information
Research has shown that people with depressive symptoms maintain negative expectations even if they have positive experiences that contradict their expectations. Healthy people, however, change their expectations after unexpected positive experiences. In this experimental study, it will now be examined whether there are also differences between healthy people and people with depressive symptoms in dealing with unexpected negative experiences.
Read the detailed description
Research has already shown that people with depressive symptoms continue to hold on to negative expectations even if they have positive experiences that contradict their expectations. By contrast, healthy people change their expectations after unexpectedly positive experiences. In this experimental study, the authors will now examine whether there are also differences between healthy people and people with depressive symptoms in processing unexpectedly negative experiences. It is hypothesized that people with depressive symptoms change their expectations in a negative direction after unexpectedly negative experiences, while healthy people continue to hold on to an optimistic view.
- Conditions
- Major Depressive Disorder
- Being tested
- Expectation confirmation, Expectation disconfirmation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectation confirmationBehavioural
Participants receive manipulated feedback indicating that their performance was above average in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance.
Expectation disconfirmationBehavioural
Participants receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance.
| Study group | Role | What they receive |
|---|---|---|
| Expectation confirmation | Experimental | The participants in this group receive manipulated feedback indicating that their performance was very good in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance. Receives: Behavioral: Expectation confirmation |
| Expectation disconfirmation | Experimental | The participants in this group receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance. Receives: Behavioral: Expectation disconfirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Item Performance Expectations Scale - generalized
Changes from baseline to postassessment in generalized performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.
Measured: Immediately before the performance test and immediately after completion of the performance test
Secondary outcomes (1)
2-Item Performance Expectations Scale - task-specific
Changes from baseline to postassessment in task-specific performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.
Measured: Immediately before the performance test and immediately after completion of the performance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start11 Nov 2018
- Primary completion30 Mar 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Model description
- Participants are assigned to one of two experimental groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Kube, PhD, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780881
- Sponsor's protocol ID
- 2018-37k
- Acronym
- EXPECD4
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worse Than Expected - Differences Between Healthy and Depressed People in Processing Unexpectedly Negative Information
- ClinicalTrials.gov ID
- NCT03780881
- Acronym / sponsor ID
- EXPECD4 / 2018-37k
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 19 Dec 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.
Research has shown that people with depressive symptoms maintain negative expectations even if they have positive experiences that contradict their expectations. Healthy people, however, change their expectations after unexpected positive experiences. In this experimental study, it will now be examined whether there are also differences between healthy people and people with depressive symptoms in dealing with unexpected negative experiences.
Detailed description
Research has already shown that people with depressive symptoms continue to hold on to negative expectations even if they have positive experiences that contradict their expectations. By contrast, healthy people change their expectations after unexpectedly positive experiences. In this experimental study, the authors will now examine whether there are also differences between healthy people and people with depressive symptoms in processing unexpectedly negative experiences. It is hypothesized that people with depressive symptoms change their expectations in a negative direction after unexpectedly negative experiences, while healthy people continue to hold on to an optimistic view.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Expectation confirmation | Experimental | Behavioral: Expectation confirmationThe participants in this group receive manipulated feedback indicating that their performance was very good in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance. |
| Expectation disconfirmation | Experimental | Behavioral: Expectation disconfirmationThe participants in this group receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of major depression
- at least 18 years old
- sufficient German language skills
- at least 18 years old
- sufficient German language skills
Key exclusion criteria (5 listed)
- participation in previous studies on changes in expectations
- participation in previous studies on changes in expectations
- current diagnosis of any mental disorder
- diagnosis of major depression in the past
- currently receiving psychotherapeutic treatment
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 |
|---|---|---|
| Expectation confirmationParticipants receive manipulated feedback indicating that their performance was above average in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance. | Behavioural | Expectation confirmation |
| Expectation disconfirmationParticipants receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance. | Behavioural | Expectation disconfirmation |
Primary outcome
2-Item Performance Expectations Scale - generalized
Time frame: Immediately before the performance test and immediately after completion of the performance test
Changes from baseline to postassessment in generalized performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.
1 secondary outcome
2-Item Performance Expectations Scale - task-specific
Time frame: Immediately before the performance test and immediately after completion of the performance test
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 5 Dec 2023.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
Tobias Kube, PhD 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 confirmation and Expectation disconfirmation in people with Major Depressive Disorder, 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 5 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 5 Dec 2023. 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?
2-Item Performance Expectations Scale - generalized (time frame: Immediately before the performance test and immediately after completion of the performance test). 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 5 Dec 2023.