Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-02-28

Brief Summary

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Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

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Detailed Description

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Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.

Conditions

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Panic Disorder Agoraphobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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70% VO2max

Cognitive Behavioural Therapy (CBT)

\+ aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure

30% VO2max

Cognitive Behavioural Therapy (CBT)

\+ placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure

Interventions

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Cognitive Behavioural Therapy

12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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Inclusion Criteria

* Subject familiarized with experimental procedure and had given written informed consent
* Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* Score \>= 18 in Hamilton Rating Scale for Anxiety
* Score \>= 4 in Clinical Global Index
* Reachability of patient for treatment and follow-up

Exclusion Criteria

* DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II borderline personality disorder
* Change in pharmacological treatment in the last 4 weeks
* Acute suicidality
* Medical contraindications for mild to moderate exercise training or exposure

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No