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

Primary Purpose

Panic Disorder

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Physical exercise
Cognitive-behavioral therapy
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Solli Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical exercise

Cognitive-behavioral therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mobility Inventory (MI) - Alone & Accompanied
Agoraphobic Cognitions Questionnaire (ACQ)
Body Sensations Questionnaire
Panic frequency - Self-report & Clinician-rating
Panic distress/disability - Self-report & Clinician-rating

Secondary Outcome Measures

Beck Anxiety Inventory (BAI)
State-Trait Anxiety Inventory - State & Trait (STAI S/T)
Beck Depression Inventory II (BDI-II)
Quality of Life Inventory (QoLI)

Full Information

First Posted
February 25, 2010
Last Updated
February 25, 2010
Sponsor
University of Bergen
Collaborators
Norwegian Department of Health and Social Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01076777
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bergen
Collaborators
Norwegian Department of Health and Social Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise
Arm Type
Experimental
Arm Description
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
Arm Title
Cognitive-behavioral therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
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 Measure Information:
Title
Mobility Inventory (MI) - Alone & Accompanied
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Agoraphobic Cognitions Questionnaire (ACQ)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Body Sensations Questionnaire
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Panic frequency - Self-report & Clinician-rating
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Panic distress/disability - Self-report & Clinician-rating
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
State-Trait Anxiety Inventory - State & Trait (STAI S/T)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Beck Depression Inventory II (BDI-II)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Title
Quality of Life Inventory (QoLI)
Time Frame
Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Hovland, PsyD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solli Hospital
City
Bergen
State/Province
Nesttun
ZIP/Postal Code
5221
Country
Norway

12. IPD Sharing Statement

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

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