Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05718271

Collaborator

(none)

240

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder	Other: Explicit instructions before extinction Other: Explicit instructions after extinction	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Explicit instructions before + after extinction	Other: Explicit instructions before extinction "Shocks will no longer be administered during the next phase." Other: Explicit instructions after extinction "Tomorrow no shocks will be administered."
Experimental: Explicit instructions before extinction	Other: Explicit instructions before extinction "Shocks will no longer be administered during the next phase."
Experimental: Explicit instructions after extinction	Other: Explicit instructions after extinction "Tomorrow no shocks will be administered."
No Intervention: No explicit instructions

Outcome Measures

Primary Outcome Measures

Fear extinction learning [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?").
Extinction retrieval [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 Outcome Measures

Fear acquisition [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?").
Contingency awareness [Experimental Day 1]
After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.

Other Outcome Measures

Score on Intolerance of Uncertainty Scale [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.
Score on General Self-efficacy (GSE) Scale [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.
Trait Anxiety score on State-Trait-Anxiety Inventory [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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