- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076777
Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
February 25, 2010 updated by: University of Bergen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nesttun
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Bergen, Nesttun, Norway, 5221
- Solli Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mobility Inventory (MI) - Alone & Accompanied
Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
|
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
|
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
|
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
|
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
|
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Anxiety Inventory (BAI)
Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
|
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
|
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
|
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
|
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders Hovland, PsyD, University of Bergen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 25, 2010
First Submitted That Met QC Criteria
February 25, 2010
First Posted (Estimate)
February 26, 2010
Study Record Updates
Last Update Posted (Estimate)
February 26, 2010
Last Update Submitted That Met QC Criteria
February 25, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3.2007.499 (REK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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