NCT01076777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
Last Updated

February 26, 2010

Status Verified

February 1, 2010

Enrollment Period

2.6 years

First QC Date

February 25, 2010

Last Update Submit

February 25, 2010

Conditions

Panic Disorder

Keywords

Panic disorderPhysical exerciseCognitive-behavioral therapyManualized

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Physical exercise

EXPERIMENTAL

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

Behavioral: Physical exercise

Cognitive-behavioral therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive-behavioral therapy

Interventions

Physical exerciseBEHAVIORAL

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

Physical exercise
Cognitive-behavioral therapyBEHAVIORAL

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

Cognitive-behavioral therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Solli Hospital

Bergen, Nesttun, 5221, Norway

Location

MeSH Terms

Conditions

Panic DisorderMotor Activity

Interventions

ExerciseCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anders Hovland, PsyD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 26, 2010

Record last verified: 2010-02

Locations

NO(1)