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Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

Primary Purpose

Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Explicit instructions before extinction
Explicit instructions after extinction
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Disorder focused on measuring anxiety disorders, fear extinction, fear conditioning, instructions, contingencies

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Ruhr University BochumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Explicit instructions before + after extinction

Explicit instructions before extinction

Explicit instructions after extinction

No explicit instructions

Arm Description

Outcomes

Primary Outcome Measures

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?").
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?").

Secondary Outcome Measures

Fear acquisition
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?").
Contingency awareness
After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.

Full Information

First Posted
January 30, 2023
Last Updated
February 17, 2023
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT05718271
Brief Title
Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval
Official Title
The Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval in Patients With Anxiety Disorders and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

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

5. Study Description

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.
Detailed Description
Patients with anxiety disorders (AD) and highly anxious individuals show accelerated fear conditioning and diminished fear extinction learning (Duits et al., 2015). The aim of the current study is to investigate how verbal instructions impact fear extinction learning and extinction retrieval in AD patients and healthy controls. Using a 3-day fear conditioning paradigm, fear acquisition will take place on the first, extinction training on the second, and extinction retrieval and reinstatement on the third day (i.e., all phases are on consecutive days). Part of the participants will receive explicit instructions such that the unconditioned stimulus (UCS) won't be presented anymore, either before and/or after extinction training. Participants will be randomly assigned to four conditions: (1) no explicit instructions at all, (2) explicit instructions before extinction, (3) explicit instructions after extinction or (4) explicit instructions before and after extinction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
anxiety disorders, fear extinction, fear conditioning, instructions, contingencies

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Explicit instructions before + after extinction
Arm Type
Experimental
Arm Title
Explicit instructions before extinction
Arm Type
Experimental
Arm Title
Explicit instructions after extinction
Arm Type
Experimental
Arm Title
No explicit instructions
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Explicit instructions before extinction
Intervention Description
"Shocks will no longer be administered during the next phase."
Intervention Type
Other
Intervention Name(s)
Explicit instructions after extinction
Intervention Description
"Tomorrow no shocks will be administered."
Primary Outcome Measure Information:
Title
Fear extinction learning
Description
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?").
Time Frame
Experimental Day 2
Title
Extinction retrieval
Description
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?").
Time Frame
Experimental Day 3
Secondary Outcome Measure Information:
Title
Fear acquisition
Description
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?").
Time Frame
Experimental Day 1
Title
Contingency awareness
Description
After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.
Time Frame
Experimental Day 1
Other Pre-specified Outcome Measures:
Title
Score on Intolerance of Uncertainty Scale
Description
The Intolerance of Uncertainty Scale measures a person's degree of vigilance, burden and disturbed action ability when experiencing uncertain situations. The items are scored on a 5-point scale from 1 = "not at all characteristic of me' to 5 = "entirely characteristic of me" and higher IU scale scores are related to higher intolerance of uncertainty. High IU supposedly plays an important role in maintaining fear and anxiety and is related to poorer fear extinction.
Time Frame
Experimental Day 1
Title
Score on General Self-efficacy (GSE) Scale
Description
The GSE Scale contains ten items and measures how confident the person feels to overcome difficult situations based on their self-assessed competence. The GSE items are scored on a four-point scale with 1 = not at all true, 2 = hardly true, 3 = moderately true and 4 = exactly true. The total score is determined by summing up all item scores, which results in a score between 10 and 40, where the higher scores represent higher GSE.
Time Frame
Experimental Day 1
Title
Trait Anxiety score on State-Trait-Anxiety Inventory
Description
Trait anxiety will be measured with 20 items of the State-Trait Anxiety Inventory. The items are measured on a four-point scale ranging from 1 = hardly ever to 4 = always. The total score of trait anxiety is calculated by summing up the scores (ranging from 20 to 80), whereby higher scores are indicative of higher trait anxiety.
Time Frame
Experimental Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annalisa Lipp, M. Sc.
Phone
+492343228068
Email
annalisa.lipp@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zlomuzica, PhD
Organizational Affiliation
Ruhr University Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcella L Woud, PhD
Organizational Affiliation
Ruhr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhr University Bochum
City
Bochum
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa Lipp
Email
annalisa.lipp@rub.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
25703487
Citation
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.
Results Reference
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Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

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