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ISRCTN
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ISRCTN12042066
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ClinicalTrials.gov identifier
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Public title
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Acceptance and commitment therapy (ACT) for treatment-resistant panic disorder with agoraphobia
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Scientific title
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What to do when the gold standard fails? A randomised controlled trial of acceptance and commitment therapy (ACT) for treatment resistant patients diagnosed with panic disorder with agoraphobia
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Acronym
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N/A
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Serial number at source
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01GV0615
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Study hypothesis
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Patients in the acceptance and commitment therapy (ACT) condition will have better outcomes than the control group.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus Ethic Committee approved on the 15th February 2010 (ref: EK 303102009)
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Study design
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Randomized Wait-List Controlled
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Panic disorder/agoraphobia
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Participants - inclusion criteria
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1. Aged 18 - 65 years, either sex
2. Diagnosis of panic disorder (PD) and/or agoraphobia (AG)
3. Either Mobility Inventory greater than or equal to 1.5 or Clinical Global Interview greater than or equal to 4
4. Informed consent
5. Completed an adequate course of psychological or pharmacological treatment (Added 11/08/2011)
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Participants - exclusion criteria
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1. Acute suicidality
2. Bipolar disorder
3. Any psychotic disorder
4. Any eating disorder
5. Acute alcohol/drug dependency
6. Current psychological treatment
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Anticipated start date
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12/07/2010
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Anticipated end date
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15/07/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60
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Interventions
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1. Acceptance and commitment therapy (ACT), administered twice weekly over four weeks for a total of 8 sessions. Each session will range between 60 - 120 minutes.
2. Waitlist control, total duration of 4 weeks
Total duration of follow-up is 6 months.
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Primary outcome measure(s)
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Measured pre-, post-, and 6-month follow up:
1. Mobility Inventory
2. Clinical Global Interview
3. Panic Agoraphobia Scale
4. Acceptance and Commitment Questionnaire-II
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Secondary outcome measure(s)
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Measured pre-, post-, and 6-month follow up:
1. Personal Values Questionnaire
2. Anxiety Sensitivity Index
3. Agoraphobic Cognitions Questionnaire
4. Body Symptoms Questionnaire
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Sources of funding
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German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615)
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Trial website
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Publications
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Contact name
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Dr
Andrew
Gloster
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Address
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Institute for Clinical Psychology and Psychotherapy
Chemnitzer Str. 46
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City/town
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Dresden
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Zip/Postcode
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01187
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Country
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Germany
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Sponsor
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Federal Ministry of Education and Research (BMBF)/German Aerospace Center (DLR) (Germany)
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Address
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Projekträger im DLR
Heinrich-Konen-Straße 1
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City/town
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Bonn
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Zip/Postcode
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53227
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Country
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Germany
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Sponsor website:
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http://www.pt-dlr.de
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Date applied
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09/07/2010
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Last edited
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16/08/2011
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Date ISRCTN assigned
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26/07/2010
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