Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

Charite University, Berlin, Germany46 enrolled

Overview

Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Panic Disorder

Interventions

Cognitive Behavioural Therapy (CBT)BEHAVIORAL

9 sessions of CBT including psychoeducation and interoceptive exposure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hamilton Rating Scale for Anxiety (CIPS 1995)

Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder

Time frame: up to 28 weeks (follow up)

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)

Data from ClinicalTrials.gov

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