Acceptance and commitment therapy (ACT) for treatment-resistant panic disorder with agoraphobia

ISRCTN ISRCTN12042066
DOI https://doi.org/10.1186/ISRCTN12042066
Secondary identifying numbers 01GV0615
Submission date
09/07/2010
Registration date
26/07/2010
Last edited
16/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Gloster
Scientific

Institute for Clinical Psychology and Psychotherapy
Chemnitzer Str. 46
Dresden
01187
Germany

Study information

Study designRandomized Wait-List Controlled
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleWhat 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
Study objectivesPatients in the acceptance and commitment therapy (ACT) condition will have better outcomes than the control group.
Ethics approval(s)Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus Ethic Committee approved on the 15th February 2010 (ref: EK 303102009)
Health condition(s) or problem(s) studiedPanic disorder/agoraphobia
Intervention1. 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 typeOther
Primary outcome measureMeasured 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 measuresMeasured pre-, post-, and 6-month follow up:
1. Personal Values Questionnaire
2. Anxiety Sensitivity Index
3. Agoraphobic Cognitions Questionnaire
4. Body Symptoms Questionnaire
Overall study start date12/07/2010
Completion date15/07/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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)
Key exclusion criteria1. Acute suicidality
2. Bipolar disorder
3. Any psychotic disorder
4. Any eating disorder
5. Acute alcohol/drug dependency
6. Current psychological treatment
Date of first enrolment12/07/2010
Date of final enrolment15/07/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

Institute for Clinical Psychology and Psychotherapy
Dresden
01187
Germany

Sponsor information

Federal Ministry of Education and Research (BMBF)/German Aerospace Center (DLR) (Germany)
Government

Projekträger im DLR
Heinrich-Konen-Straße 1
Bonn
53227
Germany

http://www.pt-dlr.de
ROR logo https://ror.org/04pz7b180

Funders

Funder type

Government

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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