Targeting Cognitive Immunization in Depression

How Can Change of Dysfunctional Expectations in Major Depression be Enhanced? An Experimental Study Targeting Cognitive Immunization

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: INFORMATION; Behavioral: SALIENCE; Behavioral: ATTENTION; Behavioral: CONTROL

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Bad Arolsen, Hessen, Germany, 34454
      • Schoen Klinik Bad Arolsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Expectations Scale - task-specific	Change from Baseline to Postassessment in task-specific performance expectations	Directly prior to the performance test and directly after completing the performance test

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2017
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): August 21, 2018

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (ACTUAL): March 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2017-39k

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No