Targeting Cognitive Immunization in Depression

NCT ID: NCT03460574

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-14

Study Completion Date

2018-08-21

Brief Summary

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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.

Detailed Description

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It appears adaptive to change one's expectations when continuously gaining expectation-disconfirming experiences; however, research has shown that people suffering from MDD have difficulty in changing their expectations after experiences that disconfirm expectations. Recently, the investigators have shown that this persistence of expectations is due to maladaptive information processing involving "cognitive immunization", defined as a cognitive reappraisal of expectation-disconfirming experiences in such a way that the individual's expectations are maintained. In view of psychotherapeutic interventions aiming to modify patients' dysfunctional expectations, effective strategies to inhibit cognitive immunization strategies need to be identified. Therefore, the aim of this study was to compare different immunization-inhibiting strategies with regard to their effectivity in enhancing expectation change. For this purpose, the investigators use a standardized experimental paradigm, which was developed and validated in a previous study.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Participants are assigned to one of four experimental groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.

Study Groups

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INFORMATION

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.

Group Type EXPERIMENTAL

INFORMATION

Intervention Type BEHAVIORAL

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.

SALIENCE

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.

Group Type EXPERIMENTAL

SALIENCE

Intervention Type BEHAVIORAL

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.

ATTENTION

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.

Group Type EXPERIMENTAL

ATTENTION

Intervention Type BEHAVIORAL

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.

CONTROL

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

Group Type EXPERIMENTAL

CONTROL

Intervention Type BEHAVIORAL

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

Interventions

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INFORMATION

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.

Intervention Type BEHAVIORAL

SALIENCE

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.

Intervention Type BEHAVIORAL

ATTENTION

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.

Intervention Type BEHAVIORAL

CONTROL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Kube, M. Sc.

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Locations

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Schoen Klinik Bad Arolsen

Bad Arolsen, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 29253640 (View on PubMed)

Other Identifiers

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2017-39k

Identifier Type: -

Identifier Source: org_study_id

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