NCT03780881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 18, 2018

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately before the performance test and immediately after completion of the performance test

Secondary Outcomes (1)

  • 2-Item Performance Expectations Scale - task-specific

    Immediately before the performance test and immediately after completion of the performance test

Other Outcomes (1)

  • 5-Item Cognitive Immunization after Performance Feedback (CIPF) scale

    Immediately after completion of the performance test

Study Arms (2)

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.

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.

Behavioral: Expectation disconfirmation

Interventions

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 confirmation

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.

Expectation disconfirmation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of major depression
  • at least 18 years old
  • sufficient German language skills

You may not qualify if:

  • participation in previous studies on changes in expectations
  • at least 18 years old
  • sufficient German language skills
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Klinik Bad Arolsen

Bad Arolsen, Hesse, 34454, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Tobias Kube, PhD

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two experimental groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 19, 2018

Study Start

November 11, 2018

Primary Completion

March 30, 2019

Study Completion

August 31, 2019

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations