Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
Primary Purpose
Panic Disorder
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Physical exercise
Cognitive-behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized
Eligibility 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.
Sites / Locations
- Solli Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical exercise
Cognitive-behavioral therapy
Arm Description
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) 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
Outcomes
Primary Outcome Measures
Mobility Inventory (MI) - Alone & Accompanied
Agoraphobic Cognitions Questionnaire (ACQ)
Body Sensations Questionnaire
Panic frequency - Self-report & Clinician-rating
Panic distress/disability - Self-report & Clinician-rating
Secondary Outcome Measures
Beck Anxiety Inventory (BAI)
State-Trait Anxiety Inventory - State & Trait (STAI S/T)
Beck Depression Inventory II (BDI-II)
Quality of Life Inventory (QoLI)
Full Information
NCT ID
NCT01076777
First Posted
February 25, 2010
Last Updated
February 25, 2010
Sponsor
University of Bergen
Collaborators
Norwegian Department of Health and Social Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01076777
Brief Title
Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
Official Title
Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bergen
Collaborators
Norwegian Department of Health and Social Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical exercise
Arm Type
Experimental
Arm Description
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
Arm Title
Cognitive-behavioral therapy
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Mobility Inventory (MI) - Alone & Accompanied
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Agoraphobic Cognitions Questionnaire (ACQ)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Body Sensations Questionnaire
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Panic frequency - Self-report & Clinician-rating
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Panic distress/disability - Self-report & Clinician-rating
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
State-Trait Anxiety Inventory - State & Trait (STAI S/T)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Beck Depression Inventory II (BDI-II)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Quality of Life Inventory (QoLI)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Hovland, PsyD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solli Hospital
City
Bergen
State/Province
Nesttun
ZIP/Postal Code
5221
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
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