Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

NCT ID: NCT01788800

Last Updated: 2013-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercise training

Cognitive Behavioural Therapy (CBT)

\+ Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy (CBT)

Intervention Type BEHAVIORAL

9 sessions of CBT including psychoeducation and interoceptive exposure

Movements

Cognitive Behavioural Therapy (CBT)

\+ Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Therapy (CBT)

Intervention Type BEHAVIORAL

9 sessions of CBT including psychoeducation and interoceptive exposure

Interventions

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Cognitive Behavioural Therapy (CBT)

9 sessions of CBT including psychoeducation and interoceptive exposure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Ströhle

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Ströhle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin

Related Links

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Other Identifiers

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221012

Identifier Type: -

Identifier Source: org_study_id

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