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

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ClinicalTrials.gov Identifier: NCT01076777
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Collaborator:
Norwegian Department of Health and Social Affairs
Information provided by:
University of Bergen

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE February 26, 2010
Last Update Posted Date February 26, 2010
Study Start Date  ICMJE May 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • Mobility Inventory (MI) - Alone & Accompanied [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • Agoraphobic Cognitions Questionnaire (ACQ) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • Body Sensations Questionnaire [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • Panic frequency - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • Panic distress/disability - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • Beck Anxiety Inventory (BAI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • State-Trait Anxiety Inventory - State & Trait (STAI S/T) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  • Quality of Life Inventory (QoLI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
Official Title  ICMJE Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2010)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01076777
Other Study ID Numbers  ICMJE 3.2007.499 (REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Inger Hilde Nordhus, Faculty of Psychology at University of Bergen
Study Sponsor  ICMJE University of Bergen
Collaborators  ICMJE Norwegian Department of Health and Social Affairs
Investigators  ICMJE
Principal Investigator: Anders Hovland, PsyD University of Bergen
PRS Account University of Bergen
Verification Date February 2010

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