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Clinical Trials/NCT01076777
NCT01076777
Completed
Phase 2

Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit

University of Bergen1 site in 1 country36 target enrollmentMay 2007
ConditionsPanic Disorder

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Panic Disorder
Sponsor
University of Bergen
Enrollment
36
Locations
1
Primary Endpoint
Mobility Inventory (MI) - Alone & Accompanied
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
December 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Beck Anxiety Inventory (BAI)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)
  • State-Trait Anxiety Inventory - State & Trait (STAI S/T)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)
  • Beck Depression Inventory II (BDI-II)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)
  • Quality of Life Inventory (QoLI)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)

Study Sites (1)

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