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

ISRCTN	ISRCTN12042066
DOI	https://doi.org/10.1186/ISRCTN12042066
Protocol serial number	01GV0615
Sponsor	Federal Ministry of Education and Research (BMBF)/German Aerospace Center (DLR) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615)

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

Dr Andrew Gloster
Scientific

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

Primary study design	Interventional
Study design	Randomized Wait-List Controlled
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Patients 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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Measured pre-, post-, and 6-month follow up: 1. Personal Values Questionnaire 2. Anxiety Sensitivity Index 3. Agoraphobic Cognitions Questionnaire 4. Body Symptoms Questionnaire
Completion date	15/07/2012

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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)
Key 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
Date of first enrolment	12/07/2010
Date of final enrolment	15/07/2012

Institute for Clinical Psychology and Psychotherapy

Dresden
01187
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes