Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
Norwegian Department of Health and Social Affairs
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT01076777
First received: February 25, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 25, 2010
February 25, 2010
May 2007
December 2009   (final data collection date for primary outcome measure)
  • Mobility Inventory (MI) - Alone & Accompanied [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Agoraphobic Cognitions Questionnaire (ACQ) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Body Sensations Questionnaire [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Panic frequency - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Panic distress/disability - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Beck Anxiety Inventory (BAI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory - State & Trait (STAI S/T) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Quality of Life Inventory (QoLI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit

The purpose of this study is to compare manualised physical exercise conducted in groups to manualised cognitive-behavioral therapy conducted in groups as treatment for panic disorder with or without agoraphobia.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Panic Disorder
  • Behavioral: Physical exercise
    Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
  • Behavioral: Cognitive-behavioral therapy
    Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks
  • Experimental: Physical exercise
    Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
    Intervention: Behavioral: Physical exercise
  • Active Comparator: Cognitive-behavioral therapy
    Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks
    Intervention: Behavioral: Cognitive-behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent obtained
  • Clinical diagnosis of panic disorder with and without agoraphobia according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, 4th ed., text revision; American Psychiatric Association, 2000), established through administration of Structural Clinical Interview for DSM-IV axis I disorders (SCID I; First, Spitzer, Gibbon, & Williams, 1995).

Exclusion Criteria:

  • Brain-organic disorders according to DSM-IV-TR
  • The presence of psychotic disorders according to DSM-IV-TR, established through administration of SCID I
  • Present substance-abuse
  • Medical condition that excludes participation in physical activity
  • Major Depressive Disorder according to DSM-IV-TR established through administration of SCID I.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01076777
3.2007.499 (REK)
No
Professor Inger Hilde Nordhus, Faculty of Psychology at University of Bergen
University of Bergen
Norwegian Department of Health and Social Affairs
Principal Investigator: Anders Hovland, PsyD University of Bergen
University of Bergen
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP