Clinical trial NCT01076777: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Panic Disorder
Keywords: Panic disorder
Physical exercise
Cognitive-behavioral therapy
Manualized
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Norwegian Department of Health and Social Affairs
First posted: 2010-02-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mobility Inventory (MI) - Alone & Accompanied
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: Body Sensations Questionnaire
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: Panic frequency - Self-report & Clinician-rating
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: Panic distress/disability - Self-report & Clinician-rating
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: State-Trait Anxiety Inventory - State & Trait (STAI S/T)
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
measure: Quality of Life Inventory (QoLI)
timeFrame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Solli Hospital
state: Nesttun
Study officials:
affiliation: University of Bergen
name: Anders Hovland, PsyD
role: PRINCIPAL_INVESTIGATOR
References: