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Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
This study has been completed.
Sponsor:
University of Bergen
Collaborator:
Norwegian Department of Health and Social Affairs
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT01076777
First received: February 25, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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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: 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:
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| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01076777
Please refer to this study by its ClinicalTrials.gov identifier: 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) |
| Study First Received: | February 25, 2010 |
| Last Updated: | February 25, 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 |
ClinicalTrials.gov processed this record on July 27, 2017