- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03780881
EXperimental Paradigm to Investigate Expectation Change in Depression 4 (EXPECD4)
December 4, 2023 updated by: Philipps University Marburg Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
171
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
-
Bad Arolsen, Hessen, Germany, 34454
- Schoen Klinik Bad Arolsen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria (clinical sample):
- diagnosis of major depression
- at least 18 years old
- sufficient German language skills
Exclusion Criteria (clinical sample):
- participation in previous studies on changes in expectations
Inclusion Criteria (healthy sample):
- at least 18 years old
- sufficient German language skills
Exclusion Criteria (clinical sample):
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Expectation confirmation
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.
|
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.
|
|
Experimental: Expectation disconfirmation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately before the performance test and immediately after completion of the performance test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-Item Performance Expectations Scale - task-specific
Time Frame: Immediately before the performance test and immediately after completion of the performance test
|
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.
|
Immediately before the performance test and immediately after completion of the performance test
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5-Item Cognitive Immunization after Performance Feedback (CIPF) scale
Time Frame: Immediately after completion of the performance test
|
Engagement in cognitive immunization strategies after receiving performance feedback.
Each item is scored from 1 to 7 (1 = no cognitive immunization, 7 = great engagement in cognitive immunization), yielding a total score between 5 and 35.
Higher total scores reflect a greater engagement in cognitive immunization strategies.
|
Immediately after completion of the performance test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tobias Kube, PhD, Philipps University Marburg Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2018
Primary Completion (Actual)
March 30, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
December 18, 2018
First Submitted That Met QC Criteria
December 18, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
December 5, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-37k
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No IPD will be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.