Clinical trial NCT01788800: Physical Activity and Cognitive Behavioural Therapy in Panic Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Keywords: Panic disorder
Physical activity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-02-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Rating Scale for Anxiety (CIPS 1995)
timeFrame: up to 28 weeks (follow up)
Secondary outcomes:
measure: Panic and Agoraphobia Scale (Bandelow et al. 1995)
timeFrame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
measure: Beck Anxiety Inventory (CIPS 1995)
timeFrame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
measure: Clinical Global Index (CIPS 1995)
timeFrame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
measure: Beck Depression Inventory (CIPS 1995)
timeFrame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Other outcomes:
measure: EEG and endocrinology
timeFrame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Locations:
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin
name: Andreas Ströhle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: