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

Phase 2

Completed

• Conditions: Panic Disorder
• Interventions: Behavioral: Physical exercise; Behavioral: Cognitive-behavioral therapy

• Registration Number: NCT01076777
• Lead Sponsor: University of Bergen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Last Update Submitted: 2010-02-25
• Study First Posted: 2010-02-26
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical exercise	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	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

Primary Outcome Measures

Name	Time	Method
Mobility Inventory (MI) - Alone & Accompanied	Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Agoraphobic Cognitions Questionnaire (ACQ)	Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Body Sensations Questionnaire	Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic frequency - Self-report & Clinician-rating	Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic distress/disability - Self-report & Clinician-rating	Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Solli Hospital; 🇳🇴 Bergen, Nesttun, Norway