Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01GV0615
Study information
Scientific title
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
Acronym
Study hypothesis
Patients in the acceptance and commitment therapy (ACT) condition will have better outcomes than the control group.
Ethics approval
Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus Ethic Committee approved on the 15th February 2010 (ref: EK 303102009)
Study design
Randomized Wait-List Controlled
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Panic disorder/agoraphobia
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
Measured pre-, post-, and 6-month follow up:
1. Personal Values Questionnaire
2. Anxiety Sensitivity Index
3. Agoraphobic Cognitions Questionnaire
4. Body Symptoms Questionnaire
Overall trial start date
12/07/2010
Overall trial end date
15/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Acute suicidality
2. Bipolar disorder
3. Any psychotic disorder
4. Any eating disorder
5. Acute alcohol/drug dependency
6. Current psychological treatment
Recruitment start date
12/07/2010
Recruitment end date
15/07/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Institute for Clinical Psychology and Psychotherapy
Dresden
01187
Germany
Sponsor information
Organisation
Federal Ministry of Education and Research (BMBF)/German Aerospace Center (DLR) (Germany)
Sponsor details
Projekträger im DLR
Heinrich-Konen-Straße 1
Bonn
53227
Germany
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary