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

NCT ID: NCT01076777

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Panic Disorder

Keywords

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Panic disorder Physical exercise Cognitive-behavioral therapy Manualized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physical exercise

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

Group Type EXPERIMENTAL

Physical exercise

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

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

Interventions

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Physical exercise

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Psychology at University of Bergen

Principal Investigators

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Anders Hovland, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Solli Hospital

Bergen, Nesttun, Norway

Site Status

Countries

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Norway

Other Identifiers

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3.2007.499 (REK)

Identifier Type: -

Identifier Source: org_study_id