Panic Disorder Clinical Trial
Official title:
Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
Verified date | August 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective intervention, but the brain mechanisms driving recovery are largely unknown. In this experimental medicine study, it will be investigated to what degree CBT affects neural markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes which might be crucial in the process of recovery as opposed to those seen following full treatment completion. Patients with panic disorder will be recruited and randomly allocated to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group not receiving any interventions until after the experimental procedure.
Status | Completed |
Enrollment | 28 |
Est. completion date | February 1, 2016 |
Est. primary completion date | September 4, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Aged 18-70 - Sufficiently fluent in English to understand the task and instructions - PDSS score of at least 6 - At least two full panic attacks or limited symptoms attacks last 4 weeks Exclusion Criteria: - CNS-acting medication (antidepressants within last 6 months, benzodiazepine last 3 days) - Current or past history of alcohol/ drug abuse - Serious medical conditions (e.g., epilepsy, heart or respiratory problems) - Done the task before - Waiting group: under current psychotherapeutic treatment - Pregnancy - Contraindications to MRI e.g. pacemaker, mechanical heart valve, hip replacement, metal implants - Severe claustrophobia that limits ability to participate in fMRI scanning |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Oxford |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emotional processing | Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI) | Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting | |
Secondary | Clinical symptom severity - Global anxiety and depression (self-report) | Hamilton Anxiety and Depression Scale HADS | Baseline, after 4 weeks treatment/ waiting | |
Secondary | Clinical symptom severity - Fear of physical sensations (self-report) | Body Sensations Questionnaire BSQ | Baseline, after 4 weeks treatment/ waiting | |
Secondary | Clinical symptom severity - Agoraphobic fear (self-report) | Agoraphobic Cognitions Questionnaire ACQ | Baseline, after 4 weeks treatment/ waiting | |
Secondary | Clinical symptom severity - Clinical severity and improvement (clinician-report) | Clinical Global Impression Scale CGI | Baseline, after 4 weeks treatment/ waiting |
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