Smartphone-assisted exposure therapy for panic disorder and agoraphobia: an effectiveness study
Organizational Data
- DRKS-ID:
- DRKS00022204
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-10-29
- Last update in DRKS:
- 2023-05-12
- Registration type:
- Prospective
Acronym/abbreviation of the study
SAET
URL of the study
No Entry
Brief summary in lay language
In the treatment of panic disorders and agoraphobia the main focus is on so-called exposure therapy, in which patients learn to confront themselves with fear-provoking bodily sensations and situations and to endure them until the fear starts to decrease. The effectiveness of exposure therapy has been verified in many studies. But in classical exposure therapy the procedure is relatively complex: The therapist has to accompany the patient during exposure sessions, patients have to carry paper-based instructions with them and each exposure exercise needs to be logged manually. The company Mindable Health has now developed a smartphone-app (Mindable) for exposure therapy in panic disorders and agoraphobia (https://www.mindable.health). The app includes elements of pdychoeducation and a large number of exposure training sessions, which patients can carry out on their own or along with their therapist. Additionally, fear symptoms and exposure training sessions can be directly logged digitally within the app. The aim of the present study is to assess the effectiveness of the app in a sample of patients diagnosed with panic disorder and/or agoraphobia. It will be investigated to what extent Mindable is helpful in patients with frequent comorbidities who are on the waiting list for ambulatory psychotherapy or day-care treatment. Additionally, we will investigate whether app-based exposure therapy is more effective than app-based relaxation training.
Brief summary in scientific language
Panic disorders and agoraphobia are common anxiety disorders that often occur comorbidly. With cognitive behavior therapy both disorders are usually well treatable. The treatment focuses on so-called exposure therapy, in which patients learn to confront themselves with fear-provoking bodily sensation and situations and to endure them until the fear starts to decrease. Repeated exposure leads to a habituation effect, which reduces the symptoms in the long term. The effectiveness of exposure therapy has been verified in many studies. But in classical exposure therapy the procedure is relatively complex: The therapist has to accompany the patient during exposure sessions, patients have to carry paper-based instructions with them and each exposure exercise needs to be logged manually. The company Mindable Health has now, in cooperation with the Christoph-Dornier foundation for clinical psychotherapy, developed a smartphone-app (Mindable) for exposure therapy in panic disorders and agoraphobia (https://www.mindable.health). Mindable is based on a therapy manual for panic disorders and agoraphobia by Lang et al. (2018). The app includes elements of pdychoeducation and a large number of exposure training sessions, which patients can carry out on their own or along with their therapist. Additionally, fear symptoms and exposure trainings can be directly logged digitally within the app. The aim of the present study is to assess the effectiveness of Mindable in a sample of patients diagnosed with panic disorder and/or agoraphobia. It will be investigated to what extent Mindable can reduce the symptoms in patients who are on the waiting list for ambulatory psychotherapy or day-care treatment. Additionally, we will investigate whether app-based exposure therapy leads to a stronger reduction of symptoms than app-based relaxation training.
Health condition or problem studied
- ICD10:
- F41.0 - Panic disorder [episodic paroxysmal anxiety]
- ICD10:
- F40.0 - Agoraphobia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- App is based on exposition
- Arm 2:
- App is based on meditation and mindfulness
- Arm 3:
- Passive control group
Endpoints
- Primary outcome:
- After a 5-week intervention, the severity of the anxiety symptoms will be recorded by means of the questionnaires BDI, AKV, PAS, DASS, ASI, TSMS, SWE, WHOQOL-BREF, which are digitized and available in SosciSurvey. Furthermore, the app usage behaviour and user satisfaction is evaluated by means of the respective app.
- Secondary outcome:
- In the follow-up measurement after 8 weeks, the primary outcome parameters are again determined using the same instruments.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Control group receives no treatment
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Bonn
Recruitment period and number of participants
- Planned study start date:
- 2020-11-01
- Actual study start date:
- 2020-11-17
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-01-11
- Target Sample Size:
- 111
- Final Sample Size:
- 111
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- Additional Inclusion Criteria:
- Age between 18 and 60 years, fulfilment of the diagnostic criteria for a panic disorder and/or agoraphobia as defined in the DSM-5, at least 2 panic attacks within the last 2 weeks
Exclusion Criteria
Acute psychosis, pregnancy, insufficient knowledge of the german language, instable cardiovascular deseases/uncontrolled high blood pressure, other medical conditions that conflict the conduction of an exposure therapy
Addresses
Primary Sponsor
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum BonnProf. DR. Alexandra PhilipsenVenusberg-Campus 153127 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/42256BC8002AF3E7/direct/startseite-npp
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Bonn, Klinik für Psychiatrie und Psychotherapie, VR-LaborDr. rer. nat. Niclas BraunVenusberg-Campus 153127 BonnGermany
- Telephone:
- 0228-28731374
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/virtual-reality
Contact for Public Queries
- Address:
- Universitätsklinikum Bonn, Klinik für Psychiatrie und Psychotherapie, VR-LaborAnnika WiebeVenusberg-Campus 153127 BonnGermany
- Telephone:
- 0228-287-16947
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/virtual-reality
Principal Investigator
- Address:
- Universitätsklinikum Bonn, Klinik für Psychiatrie und Psychotherapie, VR-LaborDr. rer. nat. Niclas BraunVenusberg-Campus 153127 BonnGermany
- Telephone:
- 0228-28731374
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/virtual-reality
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum BonnVenusberg-Campus 153127 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukbonn.de/42256BC8002AF3E7/direct/startseite-npp
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission Medizinische Fakultät BonnVenusberg Campus 1, Geb. 0253105 BonnGermany
- Telephone:
- +49-228-28751282
- Fax:
- +49-228-28751932
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-07-09
- Ethics committee number:
- 321/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-10-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- The authors will provide the raw data on which the conclusions are based on request to any qualified researcher, starting 6 months after publication, without undue reservations.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry