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 |
| Protocol serial number | 040203-17 |
| Sponsor | German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) |
| Funder | German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised clinical trial, intervention study with two active arms and a wait-list control group |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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). |
| Health condition(s) or problem(s) studied | 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(s) |
1. Number of panic attacks/month |
| Key secondary outcome measure(s) |
1. Depressive symptoms |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 450 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Technische Universität Dresden
Dresden
01187
Germany
01187
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 | |
| Protocol article | protocol | 01/11/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/10/2021: Publication reference added.
14/04/2021: Publication reference added.
09/03/2021: Publication reference added.
