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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05718271
Enrollment
240
Registered
2023-02-08
Start date
2023-02-02
Completion date
2024-08-14
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder

Keywords

anxiety disorders, fear extinction, fear conditioning, instructions, contingencies

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.

Interventions

OTHERExplicit instructions before extinction

Shocks will no longer be administered during the next phase.

OTHERExplicit instructions after extinction

Tomorrow no shocks will be administered.

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fear extinction learningExperimental Day 2The 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 retrievalExperimental Day 3The 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

MeasureTime frameDescription
Fear acquisitionExperimental Day 1The 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 awarenessExperimental Day 1After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.

Other

MeasureTime frameDescription
Score on General Self-efficacy (GSE) ScaleExperimental Day 1The 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.
Trait Anxiety score on State-Trait-Anxiety InventoryExperimental Day 1Trait 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.
Score on Intolerance of Uncertainty ScaleExperimental Day 1The 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026