Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval

Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718271
• Other study ID #: 673
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Ruhr University of Bochum
• Contact: Annalisa Lipp, M. Sc.
• Phone: +492343228068
• Email: annalisa.lipp[@]rub.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Other:
• Explicit instructions before extinction
"Shocks will no longer be administered during the next phase."
• Explicit instructions after extinction
"Tomorrow no shocks will be administered."

Locations

Country	Name	City	State
Germany	Ruhr University Bochum	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Score on Intolerance of Uncertainty Scale	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.	Experimental Day 1
Other	Score on General Self-efficacy (GSE) Scale	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.	Experimental Day 1
Other	Trait Anxiety score on State-Trait-Anxiety Inventory	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.	Experimental Day 1
Primary	Fear extinction learning	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?").	Experimental Day 2
Primary	Extinction retrieval	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?").	Experimental Day 3
Secondary	Fear acquisition	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?").	Experimental Day 1
Secondary	Contingency awareness	After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.	Experimental Day 1