Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval
The Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval in Patients With Anxiety Disorders and Healthy Controls
1 other identifier
interventional
240
1 country
1
Brief Summary
The goal of this study is to examine if verbal instructions can improve fear extinction learning and extinction retrieval in patients with anxiety disorders (AD) and healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2023
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2024
CompletedSeptember 20, 2024
September 1, 2024
1.5 years
January 30, 2023
September 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fear extinction learning
The difference between the reinforced conditioned stimulus (CS+) and non-reinforced conditioned stimulus (CS-) will be measured on 3 different levels: skin conductance responses (SCRs), CS valence ratings ("How pleasant do you feel when you see this picture?"), and UCS expectancy ratings ("Do you think that this picture is paired with an electrical stimulation?").
Experimental Day 2
Extinction retrieval
The difference between the reinforced conditioned stimulus (CS+) and non-reinforced conditioned stimulus (CS-) will be measured on 3 different levels: skin conductance responses (SCRs), CS valence ratings ("How pleasant do you feel when you see this picture?"), and UCS expectancy ratings ("Do you think that this picture is paired with an electrical stimulation?").
Experimental Day 3
Secondary Outcomes (2)
Fear acquisition
Experimental Day 1
Contingency awareness
Experimental Day 1
Other Outcomes (3)
Score on Intolerance of Uncertainty Scale
Experimental Day 1
Score on General Self-efficacy (GSE) Scale
Experimental Day 1
Trait Anxiety score on State-Trait-Anxiety Inventory
Experimental Day 1
Study Arms (4)
Explicit instructions before + after extinction
EXPERIMENTALExplicit instructions before extinction
EXPERIMENTALExplicit instructions after extinction
EXPERIMENTALNo explicit instructions
NO INTERVENTIONInterventions
"Shocks will no longer be administered during the next phase."
"Tomorrow no shocks will be administered."
Eligibility Criteria
You may qualify if:
- For the patient group: DSM-5 anxiety disorder diagnosis via a structured clinical interview for diagnosing mental disorders (DIPS)
- For the healthy controls: no psychological disorder according to the Mini-DIPS
You may not qualify if:
- smoking
- alcohol abuse
- drug consumption
- current and chronic physical and neurological diseases
- for the patient group: anxiety not the primary diagnosis, psychological comorbidities e.g. schizophrenia, bipolar disorder, mental retardation, acute drug or alcohol addiction, personality disorder, currently in psychotherapy
- for the healthy controls: a diagnosis of psychological disorder at any point in life, ever been in psychotherapy, current and/or regular intake of medicine (incl. psychopharmaceutic medicine), current or past cognitive or neurological disorder
- for women: pregnancy, nursing period
- previous experience with fear conditioning paradigm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruhr University Bochum
Bochum, Germany
Related Publications (1)
Duits P, Cath DC, Lissek S, Hox JJ, Hamm AO, Engelhard IM, van den Hout MA, Baas JM. Updated meta-analysis of classical fear conditioning in the anxiety disorders. Depress Anxiety. 2015 Apr;32(4):239-53. doi: 10.1002/da.22353. Epub 2015 Feb 20.
PMID: 25703487BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armin Zlomuzica, PhD
Ruhr University Bochum
- PRINCIPAL INVESTIGATOR
Marcella L Woud, PhD
Ruhr University Bochum
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M. Sc.
Study Record Dates
First Submitted
January 30, 2023
First Posted
February 8, 2023
Study Start
February 2, 2023
Primary Completion
August 14, 2024
Study Completion
August 14, 2024
Last Updated
September 20, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
This study is carried out within the framework of the German Research Foundation (DFG) funded Collaborative Research Center (SFB) 1280 "Extinction learning". Within the framework of the SFB, almost 20 research groups from Bochum, Essen and Dortmund are working together. Part of the collected data is evaluated jointly. For this purpose, part of the data (e.g. skin conductance, questionnaires) and general information about the person (e.g. gender, age, schooling) are passed on in a pseudonymized form to a central project. Pseudonymized means that the participant's name and date of birth will be replaced by a code and the assignment to the person is only available for employees of this study, but not for employees of the central project.