Improving cognitive behavioural therapy for panic by identifying the active ingredients and understanding the mechanisms of action: a multicentre study

Not Applicable

Completed

• Conditions: Panic disorder with and without agoraphobia; Mental and Behavioural Disorders; Panic disorders

• Registration Number: ISRCTN80046034
• Lead Sponsor: German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)

Brief Summary

2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19876674 protocol 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21534651 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22399019 additional results regarding the impact of depression on CBT 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22921454 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32361414/ results (added 09/03/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33846417/ (added 14/04/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32987282/ (added 22/10/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-21
• Study Completion: 2008-02-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Number of panic attacks/month<br> 2. Aggregated Panic Disorder Scale and Mobility Inventory (PDS-MI) score (panic severity plus avoidance)<br> 3. Hamilton Anxiety Rating Scale<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Depressive symptoms<br> 2. Anticipatory anxiety in dark room-challenge and time in darkroom<br> 3. Psychophysiological parameters<br> 4. Neuroimaging parameters<br> 5. Ecological Momentary Assessment (EMA) parameters<br>