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ID
Source
Brief title
Health condition
Panic Disorder
CO2 challenge
interoceptive stimuli
interoceptive conditioning
Sponsors and support
Intervention
Outcome measures
Primary outcome
The subjective reports of the participants measured by the Visual Analogue Scale – Fear (VAS-F) during the test part.
Secondary outcome
The physiological responses of respiration rate, tidal volume and FetCO2 and the subjective report by Panic Symtom List (PSL) during the test part.
Background summary
More than 20% of the general population experience a panic attack once in their lives; however, only a minority goes on to develop panic disorder. The alarm theory tries to explain the etiology of panic disorder through interoceptive conditioning. To date studies concerning panic disorder and interoceptive conditioning are limited.
The aim of the present study is to establish intero-interoceptive fear conditioning in healthy participants in a differential conditioning paradigm. We want to make use of “real” interoceptive conditioned stimuli (CS): a low respiratory load and small infusions of pentagastrin will be used as CS. CO2-enriched air is used as unconditioned stimulus.
This study involves a double-blinded randomised design.Healthy volunteers with an age range between 18-65 years are included in the study. The main study outcome are the subjective reports (fear and physical symptoms) and the physiological measurements (respiration rate, tidal volume) that are assessed during the test-phase.
Study objective
We want to establish intero-interoceptive conditioning in healthy volunteers for the better understanding of the development of panic attacks into panic disorder.
Study design
All assesments are measured before and after each trial. The differences between the trial in the test part are important.
Intervention
We want to establish intero-interoceptive fear conditioning with a differential conditioning paradigm. We want to make use of “real” interoceptive conditioned stimuli (CS): A low respiratory load (1.43 kPa/l/s) resistance and small infusions of pentagastrin (0.2 µg/ kg) will be used as CS. CO2-enriched air is used as unconditioned stimulus (UCS). To rule out possible procedural effects also a placebo injection and placebo resistance is included in this study. The experiment consists of two parts, acquisition and test. During acquisition we want to establish conditioning (linking CS to the UCS). During the test part only the CS is given without the UCS.
Koen Schruers
Maastricht 6200 AB
The Netherlands
+31 (0)36 852330
Koen.Schruers@pn.unimaas.nl
Koen Schruers
Maastricht 6200 AB
The Netherlands
+31 (0)36 852330
Koen.Schruers@pn.unimaas.nl
Inclusion criteria
1. Healthy volunteers aged between 18-65 years;
2. Good physical condition.
Exclusion criteria
1. History of pulmonary disease (including asthma and lung fibrosis);
2. A psychiatric disorder;
3. History of cardiovascular disease (including cardiac failure, suspicion of infarct, cardiomyopathy, TIA, angina pectoris, arrythmias);
4. Hypertension (diastolic > 100; systolic > 170);
5. Personal or familial history of cerebral aneurysm;
6. Pregnancy;
7. Epilepsy;
8. Psychotropic medication use;
9. Use of á2- or â-blockers;
10. Idiosyncratic response to pentagastrin;
11. If participants refuse insight in deviant findings.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2261 |
NTR-old | NTR2387 |
CCMO | NL32415.068.10 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON34392 |