Clinical Trial: Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia

Brief Summary: Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

Detailed Summary: Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome:

  • Hamilton Rating Scale for Anxiety (CIPS 1995) [ Time Frame: Change from Baseline to 31 weeks (follow-up) ]
    Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
  • Mobility Inventory (Chambless 1984) [ Time Frame: Change from Baseline to 31 weeks (follow-up) ]
    A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior


Original Primary Outcome: Hamilton Rating Scale for Anxiety (CIPS 1995) [ Time Frame: Change from Baseline to 31 weeks (follow-up) ]

Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder


Current Secondary Outcome:

  • Clinical Global Index (CIPS 1995) [ Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) ]
  • Beck Depression Inventory (CIPS 1995) [ Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) ]
  • Anxiety Sensitivity Index (Taylor 1998) [ Time Frame: Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up) ]
  • Body Sensations Questionnaire (Chambless 1984) [ Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) ]
  • Agoraphobic Cognitions Questionaire (Chambless 1984) [ Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) ]
  • Panic and Agoraphobia Scale [ Time Frame: Change from baseline to 31 weeks (follow-up) ]
    Severity scale for panic disorder


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: July 26, 2013
Date Started: March 2011
Date Completion:
Last Updated: February 6, 2015
Last Verified: February 2015