Condition category
Mental and Behavioural Disorders
Date applied
09/07/2010
Date assigned
26/07/2010
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Gloster

ORCID ID

Contact details

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

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

http://www.pt-dlr.de

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

Publication citations

Additional files

Editorial Notes