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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Panic Disorder Behavioral: Physical exercise Behavioral: Cognitive-behavioral therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit
Study Start Date : May 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Physical exercise
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
 Behavioral: Physical exercise
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Mobility Inventory (MI) - Alone & Accompanied [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  2. Agoraphobic Cognitions Questionnaire (ACQ) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  3. Body Sensations Questionnaire [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  4. Panic frequency - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  5. Panic distress/disability - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]

Secondary Outcome Measures :
  1. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  2. State-Trait Anxiety Inventory - State & Trait (STAI S/T) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  3. Beck Depression Inventory II (BDI-II) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]
  4. Quality of Life Inventory (QoLI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076777


Locations
Norway
Solli Hospital
Bergen, Nesttun, Norway, 5221
Sponsors and Collaborators
University of Bergen
Norwegian Department of Health and Social Affairs
Investigators
Principal Investigator: Anders Hovland, PsyD University of Bergen
More Information
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Responsible Party: Professor Inger Hilde Nordhus, Faculty of Psychology at University of Bergen
ClinicalTrials.gov Identifier: NCT01076777     History of Changes
Other Study ID Numbers: 3.2007.499 (REK)
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010

Keywords provided by University of Bergen:
Panic disorder
Physical exercise
Cognitive-behavioral therapy
Manualized

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders