Investigation of the reactivity of the stress axes under low intensity exercise and association with therapy outcome

Not Applicable

• Conditions: F40.01; F41.0; Panic disorder [episodic paroxysmal anxiety]

• Registration Number: DRKS00028117
• Lead Sponsor: niversitätsklinikum Carl Gustav Carus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-12-31
• Study Start: 2022-02-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

n=12 patients with a primary diagnosis of panic disorder with/ without agoraphobia (between 18 and 65 years (F 40.01, F 41.0), valid and reliable assessment of the primary diagnosis according to ICD-10 and DSM-IV using DIA-X (computer-assisted DIA-X interview for mental disorders) (Wittchen, Weigel & Pfister, 1996). In case that the standardized assessment of the diagnosis is older than six months, a new standardized assessment is necessary.
-Scondary diagnoses of minor depressive disorders (ICD-10: F32.0) (besides major depressive disorders), secondary diagnosis of problematic alcohol consumption (alcohol abuse) are allowed (ICD-10: F10.1)

German as dominant language in case of multilingualism, dexterity

Exclusion Criteria

Only for patients:
Presence of other secondary anxiety disorders (Social Phobia ICD-10: F40.1), Generalized anxiety disorder (ICD-10: F41.1), obsessive-compulsory disorder (ICD-10: F42.8), posttraumatic stress disorder (PTSD) (ICD-10: F43.1), presence of any psychotic disorder (ICD-10: F20-F29) or bipolar disorder (ICD-10: F31), presence of any major depressive disorder (ICD-10: F32.1, F32.2, F32.3), substance use disorders (ICD-10: F10.2-F16.2, F18.2, F19.2) or eating disorders (ICD-10: F50), acute infections, chronic diseases (e.g. metabolic diseases, autoimmune diseases, heart diseases, blood diseases), current pregnancy

control groups:
n=12 healthy controls (matched for age and gender) between 18 and 65 years without acute and chronic medical illnesses
In order to preclude morbidity, the following examinations are realized previously, before the present study: structural magnetic resonance tomography (MRT)

Only for healthy controls:
Current or past diagnosis of panic disorder with/ without agoraphobia (F40.01, F41.0)
Presence of any other anxiety disorder (according to ICD-10: F40.1, F41.1, F42, F43, F42), psychotic (F20-F29) or bipolar disorders (F31), major depression (F32.1, F32.2, F32.3), substance use disorders (F10.2-F16.2, F18.2, F19.2), somatoform disorder (F45.0) or eating disorders (F50),
acute infections,
chronic diseases (e.g. metabolic diseases, autoimmune diseases, heart diseases, blood diseases)
current pregnancy

Exclusion criteria
For all:
-diseases of the upper respiratory tract (e.g. viral infectious diseases, allergies with swelling of the nasal mucous membrane
-neurologic diseases (z.B. craniocerbral injury, Parkinson´s disease)
-anosmia (complete loss of the sense of smell) oder hyposmia/ microsmia (partial loss of the sense of smell), Kallmann-syndrome
-medication with impact on the olfactory system (e.g. antihistamine, antidepressives, ACE-inhibitors)
-dissociative disorders
-structural brain damage (seen in MRT), also without a clinical correlate (incidental finding)
-neurostimulation, pacemaker, artificial heart valve, insulin pump or other implants (e.g. cochlear implant)
-metal inside the body (e.g. artificial limbs, vessel clips, metal dust during work)
-tattoos in the region of the head and neck as well as in chest and back area
-fixed retainers
-permanent Make-Up
-artificial limbs and artificial joints
-screwed or nailed fractures
-spirals for contraception (please discuss possible metal with the physician/ gynaecologist)
-grommet (as inserted e.g. in case of inflammation of the middle ear inside the drumhead)
-metal splinter inside tissue
-glasses (can be taken off during the examinations)
-current pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cortisol, heart, state anxiety, perceived arousal, dominance, pleasure during low intensity exercise (LIE)

Secondary Outcome Measures

Name	Time	Method
Psychopathology in different questionnaires (before and after inpatient cognitiv-behavioral therapy/ CBT);<br>questionnaires of interest are: Panic and Agoraphobia Scale, Agoraphobic Cognitions Questionnaire, Body Sensations Questionnaire, Mobility Inventory