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Improving cognitive behavioural therapy for panic by identifying the active ingredients and understanding the mechanisms of action: a multicentre study
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
4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22921454
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
  Email 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
  Email detlef.boecking@dlr.de
  Sponsor website: http://www.bmbf.de/en/index.php
Date applied 15/12/2006
Last edited 20/05/2013
Date ISRCTN assigned 21/02/2007
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