Improving cognitive behavioural therapy for panic by identifying the active ingredients and understanding the mechanisms of action: a multicentre study
| ISRCTN | ISRCTN80046034 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80046034 |
| Secondary identifying numbers | 040203-17 |
- Submission date
- 15/12/2006
- Registration date
- 21/02/2007
- Last edited
- 22/10/2021
- 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
Not provided at time of registration
Contact information
Prof Dr Hans-Ulrich Wittchen (PI) / Mr Thomas Lang
Scientific
Scientific
Technische Universität Dresden
Institute for Clinical Psychology and Psychotherapy
Chemnitzer Str. 46
Dresden
01187
Germany
| Phone | +49 (0)351 463 369 72 |
|---|---|
| lang@psychologie.tu-dresden.de |
Study information
| Study design | Randomised clinical trial, intervention study with two active arms and a wait-list control group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Improving cognitive behavioural therapy for panic by identifying the active ingredients and understanding the mechanisms of action: a multicentre study |
| 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. |
| Ethics approval(s) | The study was approved by the Ethics Committee of the Medical Faculty, Technical University Dresden on the 1st December 2006 (ref: EK 164082006). |
| Condition | Panic disorder with and without agoraphobia |
| Intervention | 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) |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/05/2007 |
| Overall study end date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 450 (375 completers) |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/05/2007 |
| Recruitment end date | 01/02/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Technische Universität Dresden
Dresden
01187
Germany
01187
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Government
Government
Heinrich-Konen-Str. 1
Bonn
53227
Germany
| Phone | +49 (0)228 3821 118 |
|---|---|
| detlef.boecking@dlr.de | |
| Website | http://www.bmbf.de/en/index.php |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2009 | Yes | No | |
| Results article | results | 01/06/2011 | Yes | No | |
| Results article | additional results regarding the impact of depression on CBT | 01/06/2012 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 01/01/2020 | 09/03/2021 | Yes | No |
| Results article | 12/04/2021 | 14/04/2021 | Yes | No | |
| Results article | 16/09/2020 | 22/10/2021 | Yes | No |
Editorial Notes
22/10/2021: Publication reference added.
14/04/2021: Publication reference added.
09/03/2021: Publication reference added.
