Panic DisorderPhase 2NCT01076777
Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
A Phase 2 study testing Physical exercise and Cognitive-behavioral therapy in people with Panic Disorder, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Physical exercise and Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- May 2007to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit
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.
- Conditions
- Panic Disorder
- Being tested
- Physical exercise, Cognitive-behavioral therapy
- Keywords
- Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized
- Medical subject headings
- Panic Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
Cognitive-behavioral therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise | Experimental | Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks Receives: 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 Receives: Behavioral: Cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility Inventory (MI) - Alone & Accompanied
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Agoraphobic Cognitions Questionnaire (ACQ)
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Body Sensations Questionnaire
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic frequency - Self-report & Clinician-rating
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic distress/disability - Self-report & Clinician-rating
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Secondary outcomes (4)
Beck Anxiety Inventory (BAI)
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
State-Trait Anxiety Inventory - State & Trait (STAI S/T)
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Beck Depression Inventory II (BDI-II)
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Quality of Life Inventory (QoLI)
Measured: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Department of Health and Social Affairs
- Investigators
- Anders Hovland, PsyD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076777
- Sponsor's protocol ID
- 3.2007.499 (REK)
- Status last verified
- Feb 2010
- First submitted
- 25 Feb 2010
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit
- ClinicalTrials.gov ID
- NCT01076777
- Acronym / sponsor ID
- 3.2007.499 (REK)
- Conditions
- Panic Disorder
- Keywords
- Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Norwegian Department of Health and Social Affairs
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise | Experimental | Behavioral: Physical exerciseManualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks |
| Cognitive-behavioral therapy | Active comparator | Behavioral: Cognitive-behavioral therapyCognitive-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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseManualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks | Behavioural | Physical exercise |
| Cognitive-behavioral therapyCognitive-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 | Behavioural | Cognitive-behavioral therapy |
Primary outcome
Mobility Inventory (MI) - Alone & Accompanied
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Agoraphobic Cognitions Questionnaire (ACQ)
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Body Sensations Questionnaire
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic frequency - Self-report & Clinician-rating
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic distress/disability - Self-report & Clinician-rating
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
4 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
State-Trait Anxiety Inventory - State & Trait (STAI S/T)
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Beck Depression Inventory II (BDI-II)
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Quality of Life Inventory (QoLI)
Time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
Related trials for Panic Disorder
Not yet recruiting
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
Panic Disorder, Agoraphobia
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
Qigong and Multicomponent Exercise in Panic Disorder
Panic Disorder, Panic Disorder (With or Without Agoraphobia)
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Hovland, PsyD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical exercise and Cognitive-behavioral therapy in people with Panic Disorder, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility Inventory (MI) - Alone & Accompanied (time frame: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.