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Targeting Cognitive Immunization in Depression

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ClinicalTrials.gov Identifier: NCT03460574
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: INFORMATION Behavioral: SALIENCE Behavioral: ATTENTION Behavioral: CONTROL Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Participants are assigned to one of four 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: Treatment
Official Title: How Can Change of Dysfunctional Expectations in Major Depression be Enhanced? An Experimental Study Targeting Cognitive Immunization
Actual Study Start Date : October 14, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : August 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Experimental: 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.
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.

Experimental: 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.
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.

Experimental: CONTROL
Participants in this condition receive no further information. Therefore, they are passing through the standard procedure of the previously developed experimental paradigm.
Behavioral: CONTROL
This group does not receive any further intervention. Instead, participants of this group pass through the standard procedure of the EXPEC paradigm.




Primary Outcome Measures :
  1. Performance Expectations Scale - generalized [ Time Frame: Directly prior to the performance test and directly after completing the performance test ]
    Change from Baseline to Postassessment in generalized performance expectations


Secondary Outcome Measures :
  1. Performance Expectations Scale - task-specific [ Time Frame: Directly prior to the performance test and directly after completing the performance test ]
    Change from Baseline to Postassessment in task-specific performance expectations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- none


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): NCT03460574


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, M. Sc. Philipps University Marburg Medical Center
Publications:
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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03460574    
Other Study ID Numbers: 2017-39k
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
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
Depressive Disorder, Major
Mood Disorders
Mental Disorders