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Completed

NCT Number: NCT01076777

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

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Behavior Mental Disorders Motor Activity

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Solli Hospital

Bergen, Nesttun, 5221, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

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

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

Primary outcomes

  1. Mobility Inventory (MI) - Alone & Accompanied

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  2. Agoraphobic Cognitions Questionnaire (ACQ)

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  3. Body Sensations Questionnaire

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  4. Panic frequency - Self-report & Clinician-rating

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  5. Panic distress/disability - Self-report & Clinician-rating

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

Secondary outcomes

  1. Beck Anxiety Inventory (BAI)

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  2. State-Trait Anxiety Inventory - State & Trait (STAI S/T)

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  3. Beck Depression Inventory II (BDI-II)

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

  4. Quality of Life Inventory (QoLI)

    Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Norwegian Department of Health and Social Affairs

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 26, 2010
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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