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| [ Print-friendly version ] |
| Improving cognitive behavioural therapy for panic by identifying the active ingredients and understanding the mechanisms of action: a multicentre study |
| ISRCTN | ISRCTN80046034 |
| DOI | 10.1186/ISRCTN80046034 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Improving cognitive behavioural therapy for panic by identifying the active ingredients and understanding the mechanisms of action: a multicentre study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 040203-17 |
| Study hypothesis |
Cognitive Behavioural Therapy (CBT) is effective in the psychological treatment of Panic Disorder (PD) and Agoraphobia (AG). However, CBT refers to a heterogeneous group of interventions, including psychoeducation, cognitive restructuring and exposure. The main active ingredients of CBT for panic disorder are yet not determined. Although exposure components appear essential to effective treatment of PD/AG, the debate related to the duration and format of exposure persist.
The current study compares two formats of a manualised CBT for panic disorder that differ only in the implementation of exposure therapy: 1. CbT refers to an exposure homework (only) condition; the therapist only assigns exposure. 2. cBT refers to exposure that is therapist-guided; the therapist will accompany the patients in the exposure situation. Hypotheses are: 1. Both Cognitive Behavioural Therapy (CBT) groups will be significantly superior to the wait-list control group in all primary outcome measures. 2. The “in-vivo-cBT" group will be significantly better than the “only-CbT” group at post-treatment and at follow-up. |
| Lay summary | Not provided at time of registration |
| Ethics approval | The study was approved by the Ethics Committee of the Medical Faculty, Technical University Dresden on the 1st December 2006 (ref: EK 164082006). |
| Study design | Randomised clinical trial, intervention study with two active arms and a wait-list control group |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Panic disorder with and without agoraphobia |
| Participants - inclusion criteria |
1. Outpatients
2. 18 to 65 years old 3. Meet current Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria of panic disorder with/without agoraphobia 4. Hamilton Anxiety Scale (HAMA) score more than or equal to 18 and a Clinical Global Impressions scale (CGI) score more than or equal to four 5. Able to attend clinic on his/her own or accompanied by significant others 6. Informed consent to participate and follow study procedures |
| Participants - exclusion criteria |
1. DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II of borderline personality disorder
2. DSM-IV Axis I disorders (other than panic disorder and agoraphobia) currently treated either by medications or non-pharmacological intervention 3. Acute suicidality (Composite International Diagnostic Interview [CIDI] scale 2+) 4. General medical contraindications |
| Anticipated start date | 01/05/2007 |
| Anticipated end date | 01/02/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 450 (375 completers) |
| Interventions |
Two treatment conditions are compared, both of them state-of-the-art-CBT:
Condition A: CBT for panic disorder with therapist-guided in-vivo exposure exercises (in-vivo cBT-group) Condition B: CBT for panic disorder with exposure elements as an homework assignment, only (only-CbT group) |
| Primary outcome measure(s) |
1. Number of panic attacks/month
2. Aggregated Panic Disorder Scale and Mobility Inventory (PDS-MI) score (panic severity plus avoidance) 3. Hamilton Anxiety Rating Scale |
| Secondary outcome measure(s) |
1. Depressive symptoms
2. Anticipatory anxiety in dark room-challenge and time in darkroom 3. Psychophysiological parameters 4. Neuroimaging parameters 5. Ecological Momentary Assessment (EMA) parameters |
| Sources of funding | German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615) |
| Trial website | http://www.panik-netz.de |
| Publications |
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19876674
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21534651 3. 2012 additional results regarding the impact of depression on CBT in http://www.ncbi.nlm.nih.gov/pubmed/22399019 |
| Contact name | Prof Dr Hans-Ulrich Wittchen (PI) / Mr Thomas Lang |
| Address |
Technische Universität Dresden
Institute for Clinical Psychology and Psychotherapy Chemnitzer Str. 46 |
| City/town | Dresden |
| Zip/Postcode | 01187 |
| Country | Germany |
| Tel | +49 (0)351 463 369 72 |
| Fax | +49 (0)351 463 369 55 |
| lang@psychologie.tu-dresden.de | |
| Sponsor | German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) |
| Address | Heinrich-Konen-Str. 1 |
| City/town | Bonn |
| Zip/Postcode | 53227 |
| Country | Germany |
| Tel | +49 (0)228 3821 118 |
| detlef.boecking@dlr.de | |
| Sponsor website: | http://www.bmbf.de/en/index.php |
| Date applied | 15/12/2006 |
| Last edited | 09/07/2012 |
| Date ISRCTN assigned | 21/02/2007 |
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