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

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Efficacy Study
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:

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 ] [ Designated as safety issue: No ]
  • Agoraphobic Cognitions Questionnaire (ACQ) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Body Sensations Questionnaire [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Panic frequency - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Panic distress/disability - Self-report & Clinician-rating [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Anxiety Inventory (BAI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory - State & Trait (STAI S/T) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]
  • Quality of Life Inventory (QoLI) [ Time Frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Affective Symptoms
Panic Disorder
Behavioral Symptoms
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013