Clinical trial NCT05718271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Keywords: anxiety disorders
fear extinction
fear conditioning
instructions
contingencies
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Fear extinction learning
timeFrame: Experimental Day 2
measure: Extinction retrieval
timeFrame: Experimental Day 3
Secondary outcomes:
measure: Fear acquisition
timeFrame: Experimental Day 1
measure: Contingency awareness
timeFrame: Experimental Day 1
Other outcomes:
measure: Score on Intolerance of Uncertainty Scale
timeFrame: Experimental Day 1
measure: Score on General Self-efficacy (GSE) Scale
timeFrame: Experimental Day 1
measure: Trait Anxiety score on State-Trait-Anxiety Inventory
timeFrame: Experimental Day 1
Locations:
city: Bochum
country: Germany
facility: Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum
name: Armin Zlomuzica, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr University Bochum
name: Marcella L Woud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.