Panic DisorderNCT01928810
Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia
A study testing Cognitive Behavioural Therapy in people with Panic Disorder and Agoraphobia, run by Charite University, Berlin, Germany.
Trial summary
Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder, Agoraphobia
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Feb 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject familiarized with experimental procedure and had given written informed consent
- Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Score >= 18 in Hamilton Rating Scale for Anxiety
- Score >= 4 in Clinical Global Index
- Reachability of patient for treatment and follow-up
Who cannot join
- DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II borderline personality disorder
- Change in pharmacological treatment in the last 4 weeks
- Acute suicidality
- Medical contraindications for mild to moderate exercise training or exposure
About this study
Official title: The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia
Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.
Read the detailed description
Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.
- Conditions
- Panic Disorder, Agoraphobia
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Panic Disorder, Agoraphobia, Physical Activity
- Medical subject headings
- Panic Disorder, Agoraphobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Also called CBT
12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure
| Study group | Role | What they receive |
|---|---|---|
| 70% VO2max | Experimental | Cognitive Behavioural Therapy (CBT)
+ aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions Receives: Behavioral: Cognitive Behavioural Therapy |
| 30% VO2max | Active comparator | Cognitive Behavioural Therapy (CBT)
+ placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions Receives: Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Anxiety (CIPS 1995)
Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
Measured: Change from Baseline to 31 weeks (follow-up)
Mobility Inventory (Chambless 1984)
A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior
Measured: Change from Baseline to 31 weeks (follow-up)
Secondary outcomes (6)
Clinical Global Index (CIPS 1995)
Measured: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Beck Depression Inventory (CIPS 1995)
Measured: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Anxiety Sensitivity Index (Taylor 1998)
Measured: Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
Body Sensations Questionnaire (Chambless 1984)
Measured: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Agoraphobic Cognitions Questionaire (Chambless 1984)
Measured: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Panic and Agoraphobia Scale
Severity scale for panic disorder
Measured: Change from baseline to 31 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startMar 2011
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
- Investigators
- Sophie Bischoff, Dipl.-Psych., Principal investigator, Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928810
- Sponsor's protocol ID
- 201015
- Status last verified
- Feb 2015
- First submitted
- 26 Jul 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia
- ClinicalTrials.gov ID
- NCT01928810
- Acronym / sponsor ID
- 201015
- Conditions
- Panic Disorder, Agoraphobia
- Keywords
- Panic Disorder, Agoraphobia, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Mar 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Aug 2013 (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.
Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.
Detailed description
Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 70% VO2max | Experimental | Behavioral: Cognitive Behavioural TherapyCognitive Behavioural Therapy (CBT) + aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions |
| 30% VO2max | Active comparator | Behavioral: Cognitive Behavioural TherapyCognitive Behavioural Therapy (CBT) + placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject familiarized with experimental procedure and had given written informed consent
- Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Score >= 18 in Hamilton Rating Scale for Anxiety
- Score >= 4 in Clinical Global Index
- Reachability of patient for treatment and follow-up
Key exclusion criteria (4 listed)
- DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II borderline personality disorder
- Change in pharmacological treatment in the last 4 weeks
- Acute suicidality
- Medical contraindications for mild to moderate exercise training or exposure
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 |
|---|---|---|
| Cognitive Behavioural TherapyAlso: CBT12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure | Behavioural | 30% VO2max, 70% VO2max |
Primary outcome
Hamilton Rating Scale for Anxiety (CIPS 1995)
Time frame: Change from Baseline to 31 weeks (follow-up)
Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
Mobility Inventory (Chambless 1984)
Time frame: Change from Baseline to 31 weeks (follow-up)
A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior
6 secondary outcomes
Clinical Global Index (CIPS 1995)
Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Beck Depression Inventory (CIPS 1995)
Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Anxiety Sensitivity Index (Taylor 1998)
Time frame: Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
Body Sensations Questionnaire (Chambless 1984)
Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Agoraphobic Cognitions Questionaire (Chambless 1984)
Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Panic and Agoraphobia Scale
Time frame: Change from baseline to 31 weeks (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 9 Feb 2015.
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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.
Sophie Bischoff, Dipl.-Psych. principal investigator
Charite
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Panic Disorder and Agoraphobia, run by Charite University, Berlin, Germany.
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 5 inclusion and 4 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Hamilton Rating Scale for Anxiety (CIPS 1995) (time frame: Change from Baseline to 31 weeks (follow-up)). The study lists 2 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 9 Feb 2015; AzTrials last refreshed its copy on 1 Nov 2026.