Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

NCT ID: NCT05718271

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2024-08-14

Brief Summary

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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

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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.

Conditions

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Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Explicit instructions before + after extinction

Group Type EXPERIMENTAL

Explicit instructions before extinction

Intervention Type OTHER

"Shocks will no longer be administered during the next phase."

Explicit instructions after extinction

Intervention Type OTHER

"Tomorrow no shocks will be administered."

Explicit instructions before extinction

Group Type EXPERIMENTAL

Explicit instructions before extinction

Intervention Type OTHER

"Shocks will no longer be administered during the next phase."

Explicit instructions after extinction

Group Type EXPERIMENTAL

Explicit instructions after extinction

Intervention Type OTHER

"Tomorrow no shocks will be administered."

No explicit instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Explicit instructions before extinction

"Shocks will no longer be administered during the next phase."

Intervention Type OTHER

Explicit instructions after extinction

"Tomorrow no shocks will be administered."

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Annalisa Lipp

M. Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Armin Zlomuzica, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Marcella L Woud, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

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Ruhr University Bochum

Bochum, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25703487 (View on PubMed)

Other Identifiers

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673

Identifier Type: -

Identifier Source: org_study_id

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