Panic DisorderNCT01788800
Physical Activity and Cognitive Behavioural Therapy in Panic Disorder
A study testing Cognitive Behavioural Therapy (CBT) in people with Panic Disorder, run by Charite University, Berlin, Germany.
Trial summary
Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to May 2013
- 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 75 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 or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
- Reachability of patient for treatment and follow-up
Who cannot join
- Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode
- Acute suicidal tendency
- Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis)
- Existence of contraindication against physical exercise
- Pregnancy or breastfeeding
- Changes of psychopharmacological treatment within the last 4 weeks
About this study
Official title: The Influence of Physical Activity on the Effect of Cognitive Behavioural Therapy, Neurobiological Parameters and Information Processing in Patients With Panic Disorder With/Without Agoraphobia
Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia
Read the detailed description
Patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month. All patients additionally complete a training of physical activity, which starts simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). Half of the patients complete training on a treadmill while the other half completes a training programme of low intensity physical activity without cardiovascular activation.
Flanking EEG (electroencephalogram) recordings shall help clarify biological processes underlying the therapeutical process.
- Conditions
- Panic Disorder
- Being tested
- Cognitive Behavioural Therapy (CBT)
- Keywords
- Panic disorder, Physical activity
- 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.
Cognitive Behavioural Therapy (CBT)Behavioural
9 sessions of CBT including psychoeducation and interoceptive exposure
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Cognitive Behavioural Therapy (CBT)
+ Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
| Movements | Active comparator | Cognitive Behavioural Therapy (CBT)
+ Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
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: up to 28 weeks (follow up)
Secondary outcomes (4)
Panic and Agoraphobia Scale (Bandelow et al. 1995)
Measured: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Anxiety Inventory (CIPS 1995)
Measured: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Clinical Global Index (CIPS 1995)
Measured: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Depression Inventory (CIPS 1995)
Measured: Baseline, 4 weeks, 8 weeks and 28 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 posted11 Feb 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionMay 2013
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
- Participant, Outcomes assessor
- Enrolment
- 46 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
- Andreas Ströhle, Prof. Dr., Principal investigator, Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788800
- Sponsor's protocol ID
- 221012
- Status last verified
- May 2013
- First submitted
- 4 Feb 2013
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Physical Activity on the Effect of Cognitive Behavioural Therapy, Neurobiological Parameters and Information Processing in Patients With Panic Disorder With/Without Agoraphobia
- ClinicalTrials.gov ID
- NCT01788800
- Acronym / sponsor ID
- 221012
- Conditions
- Panic Disorder
- Keywords
- Panic disorder, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Feb 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) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia
Detailed description
Patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month. All patients additionally complete a training of physical activity, which starts simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). Half of the patients complete training on a treadmill while the other half completes a training programme of low intensity physical activity without cardiovascular activation.
Flanking EEG (electroencephalogram) recordings shall help clarify biological processes underlying the therapeutical process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT)Cognitive Behavioural Therapy (CBT) + Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks |
| Movements | Active comparator | Behavioral: Cognitive Behavioural Therapy (CBT)Cognitive Behavioural Therapy (CBT) + Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject familiarized with experimental procedure and had given written informed consent
- Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
- Reachability of patient for treatment and follow-up
Key exclusion criteria (6 listed)
- Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode
- Acute suicidal tendency
- Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis)
- Existence of contraindication against physical exercise
- Pregnancy or breastfeeding
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 Therapy (CBT)9 sessions of CBT including psychoeducation and interoceptive exposure | Behavioural | Exercise training, Movements |
Primary outcome
Hamilton Rating Scale for Anxiety (CIPS 1995)
Time frame: up to 28 weeks (follow up)
Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
4 secondary outcomes
Panic and Agoraphobia Scale (Bandelow et al. 1995)
Time frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Anxiety Inventory (CIPS 1995)
Time frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Clinical Global Index (CIPS 1995)
Time frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Depression Inventory (CIPS 1995)
Time frame: Baseline, 4 weeks, 8 weeks and 28 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 16 May 2013.
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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.
Andreas Ströhle, Prof. Dr. principal investigator
Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) in people with Panic Disorder, 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 4 inclusion and 6 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 16 May 2013. 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: up to 28 weeks (follow up)). 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 16 May 2013.