NCT03460574

Brief Summary

Research has shown that people suffering from MDD tend to maintain dysfunctional expectations despite experiences that disconfirm expectations. Recently, it has been shown that this persistence of expectations is due to maladaptive information processing involving "cognitive immunization". This experimental study aims at testing three different strategies to inhibit cognitive immunization, in order to enhance expectation change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2017

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

October 14, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

January 29, 2018

Last Update Submit

August 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance Expectations Scale - generalized

    Change from Baseline to Postassessment in generalized performance expectations

    Directly prior to the performance test and directly after completing the performance test

Secondary Outcomes (1)

  • Performance Expectations Scale - task-specific

    Directly prior to the performance test and directly after completing the performance test

Study Arms (4)

INFORMATION

EXPERIMENTAL

Participants in this condition receive a manipulation suggesting that the performance test "TEMINT", they previously worked on, has been shown to be highly relevant for daily life and professional success. We anticipated that after receiving this fake information about the TEMINT, it would be difficult for participants to engage in cognitive immunization processes because the validity and utility of the expectation-disconfirming experience is explicitly highlighted.

Behavioral: INFORMATION

SALIENCE

EXPERIMENTAL

Participants in this condition are asked to think about how well they performed on this really difficult performance test. We anticipated that this manipulation would enhance expectation change, as the salience of the expectation-disconfirming experience was explicitly increased.

Behavioral: SALIENCE

ATTENTION

EXPERIMENTAL

Before working on the performance test, participants in this conditions receive the instruction to attentionally focus on their personal result in the performance test. Further, they are asked to specify what would be personally good result for them. We anticipated that after receiving this instruction, the expectation-disconfirming performance feedback should be salient for the participants, hence making it difficult for them to engage in cognitive immunization strategies.

Behavioral: ATTENTION

CONTROL

EXPERIMENTAL

Participants in this condition receive no further information. Therefore, they are passing through the standard procedure of the previously developed experimental paradigm.

Behavioral: CONTROL

Interventions

INFORMATIONBEHAVIORAL

After receiving expectation-disconfirming positive performance feedback, participants receive standardized information that stresses the relevance of this experience. In particular, participants are told that the performance test they worked on is highly relevant for both professional success and personal life satisfaction.

INFORMATION
SALIENCEBEHAVIORAL

After receiving expectation-disconfirming positive performance feedback, partcipants in this condition are instructed to remember how well they performed on the performance test. Using a visual analogue scale, they were asked to specify how they performed relative to the other participants.

SALIENCE
ATTENTIONBEHAVIORAL

Before working on the performance test, participants are instructed to pay attention to the feedback they receive. In particular, they are asked to enter what would be a personally good result for them. It is supposed that this shift of attention increases the salience of the expectation-disconfirming feedback.

ATTENTION
CONTROLBEHAVIORAL

This group does not receive any further intervention. Instead, participants of this group pass through the standard procedure of the EXPEC paradigm.

CONTROL

Eligibility Criteria

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

You may qualify if:

  • current diagnosis of Major Depressive Disorder
  • at least 18 years old
  • sufficient German language knowledge

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Klinik Bad Arolsen

Bad Arolsen, Hesse, 34454, Germany

Location

Related Publications (1)

  • Kube T, Rief W, Gollwitzer M, Glombiewski JA. Introducing an EXperimental Paradigm to investigate Expectation Change (EXPEC). J Behav Ther Exp Psychiatry. 2018 Jun;59:92-99. doi: 10.1016/j.jbtep.2017.12.002. Epub 2017 Dec 12.

    PMID: 29253640BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Tobias Kube, M. Sc.

    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
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Participants are assigned to one of four experimental groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

March 9, 2018

Study Start

October 14, 2017

Primary Completion

April 30, 2018

Study Completion

August 21, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations