Anxiety DisorderNCT05718271
Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval
A study testing Explicit instructions before extinction and Explicit instructions after extinction in people with Anxiety Disorder, run by Ruhr University of Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Explicit instructions before extinction and Explicit instructions after extinction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2023to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval in Patients With Anxiety Disorders and Healthy Controls
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.
Read the 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.
- Conditions
- Anxiety Disorder
- Being tested
- Explicit instructions before extinction, Explicit instructions after extinction
- Keywords
- anxiety disorders, fear extinction, fear conditioning, instructions, contingencies
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explicit instructions before extinctionOther
"Shocks will no longer be administered during the next phase."
Explicit instructions after extinctionOther
"Tomorrow no shocks will be administered."
| Study group | Role | What they receive |
|---|---|---|
| Explicit instructions before + after extinction | Experimental | Not described Receives: Other: Explicit instructions before extinction; Other: Explicit instructions after extinction |
| Explicit instructions before extinction | Experimental | Not described Receives: Other: Explicit instructions before extinction |
| Explicit instructions after extinction | Experimental | Not described Receives: Other: Explicit instructions after extinction |
| No explicit instructions | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?").
Measured: Experimental Day 2
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?").
Measured: Experimental Day 3
Secondary outcomes (2)
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?").
Measured: Experimental Day 1
Contingency awareness
After fear acquisition, it will be checked if participants can correctly determine which CS had been paired with the UCS.
Measured: Experimental Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start2 Feb 2023
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Lipp, Ruhr University of Bochum
- Investigators
- Armin Zlomuzica, PhD, Principal investigator, Ruhr University BochumMarcella L Woud, PhD, Principal investigator, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718271
- Sponsor's protocol ID
- 673
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is carried out within the framework of the German Research Foundation (DFG) funded Collaborative Research Center (SFB) 1280 "Extinction learning". Within the framework of the SFB, almost 20 research groups from Bochum, Essen and Dortmund are working together. Part of the collected data is evaluated jointly. For this purpose, part of the data (e.g. skin conductance, questionnaires) and general information about the person (e.g. gender, age, schooling) are passed on in a pseudonymized form to a central project. Pseudonymized means that the participant's name and date of birth will be replaced by a code and the assignment to the person is only available for employees of this study, but not for employees of the central project.
Publications
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.
PubMed 25703487
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Verbal Instructions on Fear Extinction and Extinction Retrieval in Patients With Anxiety Disorders and Healthy Controls
- ClinicalTrials.gov ID
- NCT05718271
- Acronym / sponsor ID
- 673
- Conditions
- Anxiety Disorder
- Keywords
- anxiety disorders, fear extinction, fear conditioning, instructions, contingencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Explicit instructions before + after extinction | Experimental | Other: Explicit instructions before extinction, Other: Explicit instructions after extinction |
| Explicit instructions before extinction | Experimental | Other: Explicit instructions before extinction |
| Explicit instructions after extinction | Experimental | Other: Explicit instructions after extinction |
| No explicit instructions | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explicit instructions before extinction"Shocks will no longer be administered during the next phase." | Other | Explicit instructions before + after extinction, Explicit instructions before extinction |
| Explicit instructions after extinction"Tomorrow no shocks will be administered." | Other | Explicit instructions after extinction, Explicit instructions before + after extinction |
Primary outcome
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?").
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?").
2 secondary outcomes
Fear acquisition
Time frame: Experimental Day 1
Contingency awareness
Time frame: Experimental Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 25703487Duits 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.
- Individual participant dataSharing planned: Yes. This study is carried out within the framework of the German Research Foundation (DFG) funded Collaborative Research Center (SFB) 1280 "Extinction learning". Within the framework of the SFB, almost 20 research groups from Bochum, Essen and Dortmund are working together. Part of the collected data is evaluated jointly. For this purpose, part of the data (e.g. skin conductance, questionnaires) and general information about the person (e.g. gender, age, schooling) are passed on in a pseudonymized form to a central project. Pseudonymized means that the participant's name and date of birth will be replaced by a code and the assignment to the person is only available for employees of this study, but not for employees of the central project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Zlomuzica, PhD principal investigator
Ruhr University Bochum
Marcella L Woud, PhD principal investigator
Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explicit instructions before extinction and Explicit instructions after extinction in people with Anxiety Disorder, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear extinction learning (time frame: Experimental Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05718271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.