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

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Expectation confirmation
Expectation disconfirmation
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Schoen Klinik Bad Arolsen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Expectation confirmation

Expectation disconfirmation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2018
Last Updated
May 13, 2019
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03780881
Brief Title
EXperimental Paradigm to Investigate Expectation Change in Depression 4
Acronym
EXPECD4
Official Title
Worse Than Expected - Differences Between Healthy and Depressed People in Processing Unexpectedly Negative Information
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two experimental groups in parallel for the duration of the study
Masking
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.
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectation confirmation
Arm Type
Experimental
Arm Description
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.
Arm Title
Expectation disconfirmation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Expectation confirmation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Expectation disconfirmation
Intervention Description
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 Measure Information:
Title
2-Item Performance Expectations Scale - generalized
Description
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.
Time Frame
Immediately before the performance test and immediately after completion of the performance test
Secondary Outcome Measure Information:
Title
2-Item Performance Expectations Scale - task-specific
Description
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.
Time Frame
Immediately before the performance test and immediately after completion of the performance test
Other Pre-specified Outcome Measures:
Title
5-Item Cognitive Immunization after Performance Feedback (CIPF) scale
Description
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.
Time Frame
Immediately after completion of the performance test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kube, PhD
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Klinik Bad Arolsen
City
Bad Arolsen
State/Province
Hessen
ZIP/Postal Code
34454
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

Learn more about this trial

EXperimental Paradigm to Investigate Expectation Change in Depression 4

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