Association of the neuroendocrine parameters of cortisol and adrenocorticotropin hormone (ACTH) during repeated exposure therapy with long-lasting therapy outcome in patients with panic disorder and agoraphobia

ISRCTN	ISRCTN15653306
DOI	https://doi.org/10.1186/ISRCTN15653306
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01 GV 0612)

Submission date: 12/11/2009
Registration date: 08/12/2009
Last edited: 21/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas Ströhle
Scientific

Clinic of Psychiatry and Psychotherapy
Campus Charité Mitte
Charitéplatz 1
Berlin
10117
Germany

Phone	+49 (0)30 450 517 034
Email	Andreas.Stroehle@charite.de

Study information

Primary study design	Observational
Study design	Observational case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Association of the neuroendocrine parameters of cortisol and adrenocorticotropin hormone (ACTH) during repeated exposure therapy with long-lasting therapy outcome in patients with panic disorder and agoraphobia: an observational study
Study objectives	During exposure, patients will release higher concentrations of stress hormones compared to controls. Concentrations of stress hormones during exposure will be related to therapy outcome.
Ethics approval(s)	Local Ethics Committee (Ethikausschuss 1 am Campus Charité - Mitte, Berlin, Germany) approved on the 6th February 2007 (ref: EA1/199/06)
Health condition(s) or problem(s) studied	Panic disorder with agoraphobia
Intervention	Eight sessions of standardised and manualised cognitive behavioural group-therapy for panic disorder and agoraphobia plus three individual exposure therapy sessions employing flooding technique, were administered. Before, during and after exposure therapy, blood samples were drawn via an indwelling catheter from each patient.
Intervention type	Other
Primary outcome measure(s)	1. Concentrations of cortisol and adrenocorticotropin hormone (ACTH) during exposure training 2. Panic and Agoraphobia Scale after therapy and at follow-up
Key secondary outcome measure(s)	1. Mobility Inventory for Agoraphobia after therapy and at follow-up 2. Beck Depression Inventory after therapy and at follow-up 3. Beck Anxiety Inventory after therapy and at follow-up 4. Hamilton Rating Scale for Depression after therapy and at follow-up 5. Hamilton Rating Scale for Anxiety after therapy and at follow-up 6. Clinical Global Impression after therapy and at follow-up
Completion date	01/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	1. Subject familiarised with experimental procedure and had given written informed consent 2. Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV), at least "moderately ill" 3. Aged 18 - 75 years, either sex 4. Sufficiently able to communicate with investigator, answer questions and fill in questionnaires 5. Reachability of patient for treatment and follow-up 6. Complience of patient 7. Undisturbed day-night rhythm
Key exclusion criteria	1. Inability to give informed consent 2. Hospitalisation in a mental institution 3. Other psychiatric illnesses like schizophrenia, substance abuse or dementia 4. Acute suicidal tendency 5. Epilepsy or other illness of the central nervous system (CNS) (e.g. brain tumour, encephalitis) 6. Severe internal medical illness, e.g., severe hypertension, severe cardiac insufficiency, condition after acute myocardial infarction, cardiac arrhythmia of severity index IV or V according to Lown grade, severe dysfunction of liver or kidney, diabetes mellitus requiring insulin treatment, disturbances of haematopoiesis 7. Pregnancy or breastfeeding 8. Changes of psychopharmacological treatment within the last 8 weeks or discontinuation of psychopharmacological treatment within less than 2 weeks before beginning of the study 9. Recent interference with diurnal cycle 10. Current psychotherapeutic treatment specific for panic disorder and/or agoraphobia 11. Participation in other study within last month before beginning of the study or during the study
Date of first enrolment	01/03/2007
Date of final enrolment	01/03/2008

Locations

Countries of recruitment

Germany

Study participating centre

Clinic of Psychiatry and Psychotherapy

Berlin
10117
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2011	21/08/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/08/2019: Publication reference and total final enrolment added.