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EXperimental Paradigm to Investigate Expectation Change in Depression 4 (EXPECD4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03780881
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Expectation confirmation Behavioral: Expectation disconfirmation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two experimental groups in parallel for the duration of the study
Masking: Single (Investigator)
Masking Description: The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.
Primary Purpose: Basic Science
Official Title: Worse Than Expected - Differences Between Healthy and Depressed People in Processing Unexpectedly Negative Information
Actual Study Start Date : November 11, 2018
Actual Primary Completion Date : March 30, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Expectation confirmation
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.
Behavioral: Expectation disconfirmation
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780881


Locations
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Germany
Schoen Klinik Bad Arolsen
Bad Arolsen, Hessen, Germany, 34454
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Tobias Kube, PhD Philipps University Marburg Medical Center

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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03780881     History of Changes
Other Study ID Numbers: 2018-37k
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms