Skip to main content
OpenTrials
Completed

NCT Number: NCT05718271

Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruhr University Bochum

Bochum, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Explicit instructions before extinction

Other

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

Explicit instructions after extinction

Other

"Tomorrow no shocks will be administered."

Primary outcomes

  1. Fear extinction learning

    Time frame: Experimental Day 2

    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?").

  2. Extinction retrieval

    Time frame: Experimental Day 3

    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 outcomes

  1. Fear acquisition

    Time frame: Experimental Day 1

    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?").

  2. Contingency awareness

    Time frame: Experimental Day 1

    After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.

Other outcomes

  1. Score on Intolerance of Uncertainty Scale

    Time frame: Experimental Day 1

    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.

  2. Score on General Self-efficacy (GSE) Scale

    Time frame: Experimental Day 1

    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.

  3. Trait Anxiety score on State-Trait-Anxiety Inventory

    Time frame: Experimental Day 1

    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.

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

The Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval in Patients With Anxiety Disorders and Healthy Controls

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.