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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01076777

First Posted: February 26, 2010

Last Update Posted: February 26, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Norwegian Department of Health and Social Affairs

Information provided by:

University of Bergen

Purpose

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	Intervention	Phase
Panic Disorder	Behavioral: Physical exercise Behavioral: Cognitive-behavioral therapy	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Exercise and Physical Fitness Health Checkup Panic Disorder

U.S. FDA Resources

Further study details as provided by University of Bergen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	36
Study Start Date:	May 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	February 25, 2010
First Posted:	February 26, 2010
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

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