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Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01928810
Enrollment
78
Registered
2013-08-27
Start date
2011-03-31
Completion date
2014-02-28
Last updated
2015-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agoraphobia, Panic Disorder

Keywords

Panic Disorder, Agoraphobia, Physical Activity

Brief summary

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

Detailed description

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%.

Interventions

BEHAVIORALCognitive Behavioural Therapy

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

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Rating Scale for Anxiety (CIPS 1995)Change from Baseline to 31 weeks (follow-up)Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
Mobility Inventory (Chambless 1984)Change from Baseline to 31 weeks (follow-up)A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior

Secondary

MeasureTime frameDescription
Anxiety Sensitivity Index (Taylor 1998)Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
Body Sensations Questionnaire (Chambless 1984)Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Clinical Global Index (CIPS 1995)Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Panic and Agoraphobia ScaleChange from baseline to 31 weeks (follow-up)Severity scale for panic disorder
Agoraphobic Cognitions Questionaire (Chambless 1984)Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Beck Depression Inventory (CIPS 1995)Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026