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 |
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DOI | https://doi.org/10.1186/ISRCTN15653306 |
Secondary identifying numbers | N/A |
- 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
Scientific
Clinic of Psychiatry and Psychotherapy
Campus Charité Mitte
Charitéplatz 1
Berlin
10117
Germany
Phone | +49 (0)30 450 517 034 |
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Andreas.Stroehle@charite.de |
Study information
Study design | Observational case-control study |
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Primary study design | Observational |
Secondary study design | Case-control study |
Study setting(s) | Hospital |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 1. Concentrations of cortisol and adrenocorticotropin hormone (ACTH) during exposure training 2. Panic and Agoraphobia Scale after therapy and at follow-up |
Secondary outcome measures | 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 |
Overall study start date | 01/03/2007 |
Completion date | 01/03/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 10 patients and 10 matched healthy controls |
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
10117
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education
University/education
c/o Professor Dr Andreas Ströhle
Clinic of Psychiatry and Psychotherapy
Campus Charité Mitte
Charitéplatz
Berlin
10117
Germany
Phone | +49 (0)30 450 517 034 |
---|---|
Andreas.Stroehle@charite.de | |
Website | http://www.charite.de/ |
https://ror.org/001w7jn25 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01 GV 0612)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |
Editorial Notes
21/08/2019: Publication reference and total final enrolment added.