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Targeting Cognitive Immunization in Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
INFORMATION
SALIENCE
ATTENTION
CONTROL
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- none

Sites / Locations

  • Schoen Klinik Bad Arolsen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

INFORMATION

SALIENCE

ATTENTION

CONTROL

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Performance Expectations Scale - generalized
Change from Baseline to Postassessment in generalized performance expectations

Secondary Outcome Measures

Performance Expectations Scale - task-specific
Change from Baseline to Postassessment in task-specific performance expectations

Full Information

First Posted
January 29, 2018
Last Updated
August 22, 2018
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03460574
Brief Title
Targeting Cognitive Immunization in Depression
Official Title
How Can Change of Dysfunctional Expectations in Major Depression be Enhanced? An Experimental Study Targeting Cognitive Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 14, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Participants are assigned to one of four experimental groups in parallel for the duration of the study
Masking
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.
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INFORMATION
Arm Type
Experimental
Arm Description
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.
Arm Title
SALIENCE
Arm Type
Experimental
Arm Description
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.
Arm Title
ATTENTION
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
Experimental
Arm Description
Participants in this condition receive no further information. Therefore, they are passing through the standard procedure of the previously developed experimental paradigm.
Intervention Type
Behavioral
Intervention Name(s)
INFORMATION
Intervention Description
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
Intervention Name(s)
SALIENCE
Intervention Description
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
Intervention Name(s)
ATTENTION
Intervention Description
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
Intervention Name(s)
CONTROL
Intervention Description
This group does not receive any further intervention. Instead, participants of this group pass through the standard procedure of the EXPEC paradigm.
Primary Outcome Measure Information:
Title
Performance Expectations Scale - generalized
Description
Change from Baseline to Postassessment in generalized performance expectations
Time Frame
Directly prior to the performance test and directly after completing the performance test
Secondary Outcome Measure Information:
Title
Performance Expectations Scale - task-specific
Description
Change from Baseline to Postassessment in task-specific performance expectations
Time Frame
Directly prior to the performance test and directly after completing the performance test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: current diagnosis of Major Depressive Disorder at least 18 years old sufficient German language knowledge Exclusion Criteria: - none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kube, M. Sc.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Klinik Bad Arolsen
City
Bad Arolsen
State/Province
Hessen
ZIP/Postal Code
34454
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared
Citations:
PubMed Identifier
29253640
Citation
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.
Results Reference
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Targeting Cognitive Immunization in Depression

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