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

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076777
• Other study ID #: 3.2007.499 (REK)
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2010
• Last updated: February 25, 2010
• Start date: May 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Behavioral:
• Physical exercise
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
• 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

Locations

Country	Name	City	State
Norway	Solli Hospital	Bergen	Nesttun

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Norwegian Department of Health and Social Affairs

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility Inventory (MI) - Alone & Accompanied		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Primary	Agoraphobic Cognitions Questionnaire (ACQ)		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Primary	Body Sensations Questionnaire		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Primary	Panic frequency - Self-report & Clinician-rating		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Primary	Panic distress/disability - Self-report & Clinician-rating		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Secondary	Beck Anxiety Inventory (BAI)		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Secondary	State-Trait Anxiety Inventory - State & Trait (STAI S/T)		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Secondary	Beck Depression Inventory II (BDI-II)		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No
Secondary	Quality of Life Inventory (QoLI)		Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up	No