Targeting Cognitive Immunization in Depression

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Germany

Schoen Klinik Bad Arolsen

Bad Arolsen, Hessen, Germany, 34454

Sponsors and Collaborators

Philipps University Marburg Medical Center

Investigators

• Principal Investigator: Tobias Kube, M. Sc.; Philipps University Marburg Medical Center

More Information

Publications:

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.

• Responsible Party: Philipps University Marburg Medical Center
• ClinicalTrials.gov Identifier: NCT03460574
• Other Study ID Numbers: 2017-39k
• First Posted: March 9, 2018
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Mental Disorders