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Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01788800
Enrollment
46
Registered
2013-02-11
Start date
2009-01-31
Completion date
2013-05-31
Last updated
2013-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder

Keywords

Panic disorder, Physical activity

Brief summary

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.

Interventions

BEHAVIORALCognitive Behavioural Therapy (CBT)

9 sessions of CBT including psychoeducation and interoceptive exposure

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Subject familiarized with experimental procedure and had given written informed consent 2. Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) 3. Sufficiently able to communicate with investigator, answer questions and fill in questionnaires 4. Reachability of patient for treatment and follow-up

Exclusion criteria

1. Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode 2. Acute suicidal tendency 3. Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis) 4. Existence of contraindication against physical exercise 5. Pregnancy or breastfeeding 6. Changes of psychopharmacological treatment within the last 4 weeks

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Rating Scale for Anxiety (CIPS 1995)up to 28 weeks (follow up)Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder

Secondary

MeasureTime frame
Panic and Agoraphobia Scale (Bandelow et al. 1995)Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Anxiety Inventory (CIPS 1995)Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Clinical Global Index (CIPS 1995)Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Depression Inventory (CIPS 1995)Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

Other

MeasureTime frameDescription
EEG and endocrinologyBaseline, 4 weeks, 8 weeks and 28 weeks (follow up)EEG (Mismatch Negativity, Loudness dependency, P50/P300) and diurnal profile of Cortisol and alpha-Amylase

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026