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 Bonn
Prof. DR. Alexandra Philipsen
Venusberg-Campus 1
53127 Bonn
Germany
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-Labor
Dr. rer. nat. Niclas Braun
Venusberg-Campus 1
53127 Bonn
Germany
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-Labor
Annika Wiebe
Venusberg-Campus 1
53127 Bonn
Germany
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-Labor
Dr. rer. nat. Niclas Braun
Venusberg-Campus 1
53127 Bonn
Germany
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 Bonn
Venusberg-Campus 1
53127 Bonn
Germany
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 Bonn
Venusberg Campus 1, Geb. 02
53105 Bonn
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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