Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

N/ACompletedNCT01928810

Charite University, Berlin, Germany78 enrolled

Overview

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

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Panic Disorder Agoraphobia

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

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: Change from Baseline to 31 weeks (follow-up)

Mobility Inventory (Chambless 1984)

A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior

Time frame: Change from Baseline to 31 weeks (follow-up)

Secondary Outcomes

Clinical Global Index (CIPS 1995)

Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)

Beck Depression Inventory (CIPS 1995)

Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)

Anxiety Sensitivity Index (Taylor 1998)

Time frame: Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)

Body Sensations Questionnaire (Chambless 1984)

Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)

Agoraphobic Cognitions Questionaire (Chambless 1984)

Time frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)

Panic and Agoraphobia Scale

Severity scale for panic disorder

Time frame: Change from baseline to 31 weeks (follow-up)

Data from ClinicalTrials.gov

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