Evaluation of a smartphone app for patients with panic disorder with or without comorbid agoraphobia
Organizational Data
- DRKS-ID:
- DRKS00029090
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-06-10
- Last update in DRKS:
- 2023-06-20
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
Brief summary in lay language
The study investigates the effects of a digital health app (DiGa) for individuals with panic disorder and/or agoraphobia who are not currently undergoing psychotherapy. Study participants will be randomly assigned to either an app group or a waiting control group. The app group will receive the app "mindable" for free use, which contains information and self-help applications for the treatment of panic disorder with and without agoraphobia. Participant:s will then be able to use the app for 8 weeks. It will be investigated whether the use of the app - compared to no intervention - leads to reductions in anxiety symptoms and quality of life.
Brief summary in scientific language
The study aims to evaluate possible positive care effects of a digital health application for individuals with panic disorder with and without comorbid agoraphobia. It is planned as a multicenter randomized controlled trial. The study will enroll individuals over the age of 18 who meet diagnostic criteria for panic disorder, panic disorder with comorbid agoraphobia, or agoraphobia. Eligible participants:will be randomly assigned to an app group or a WArte control group. The study period will be 8 weeks with baseline, interim (after week 4), and post (after week 8) study time points. The main outcome measures include anxiety-related measures, process-related measures (mediators), and quality of life measures.
Health condition or problem studied
- ICD10:
- F41.0 - Panic disorder [episodic paroxysmal anxiety]
- ICD10:
- F40.01
- ICD10:
- F40.00
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- App use, 8 weeks period
- Arm 2:
- wait-list control
Endpoints
- Primary outcome:
- Post-Assessment 8 weeks after study intake primary outcomes: anxiety symptoms: Panic- and Agoraphobia-Scale (PAS), questionnaire quality of life: WHO-quality of life scale (WHOQOL-BREF), questionnaire perceived control: Anxiety Control Questionnaire (ACQ); questionnaire
- Secondary outcome:
- Agoraphobic Cognitions Questionnaire, Bodily Sensations Questionnaire (Chambless et al., 1984) Beck Depression Inventory II (Beck et al., 1996) Brief Symptom Inventory (Derogatis, 1992)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Factorial
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other Jacobs University Bremen Bremen
- Other Psychotherapeutische Ambulanz der Psychotherapieausbildung an der Universität Hamburg Hamburg
- Other Institut für Psychologische Psychotherapieausbildung IPP Münster Münster
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2021-08-04
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-11-11
- Target Sample Size:
- 90
- Final Sample Size:
- 107
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- One of the following diagnoses: F41.0, F40.00, F40.01; informed consent; Minimum age of 18 years
Exclusion Criteria
no smartphone; intake of benzodiazepines; initiation or changes in a psychopharmacotherapy during the last 2 months; komorbid psychotic disorder; komorbid substance use disorder; comorbid chronic cardiovascular or pneumological disorders; acute suicidality; ongoing psychotherapeutic treatment; not fluid in German language
Addresses
Primary Sponsor
- Address:
- Mindable Health GmbHLinda WeberNeue Grünstraße 1710179 BerlinGermany
- Telephone:
- +493062923386
- Fax:
- +493062923734
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mindable.health
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Jacobs University BremenProfessor Thomas LangCampus Ring 128759 BremenGermany
- Telephone:
- 0421-200-4884
- Fax:
- 0421-200-491234
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.jacobs-university.de
Contact for Public Queries
- Address:
- Christoph-Dornier-StiftungM. Sc. Susanne ChristGrazer Str. 2b28359 BremenGermany
- Telephone:
- 0421 / 200 4881
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Jacobs University BremenProfessor Thomas LangCampus Ring 128759 BremenGermany
- Telephone:
- 0421-200-4884
- Fax:
- 0421-200-491234
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.jacobs-university.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Mindable Health GmbHNeue Grünstraße 1710179 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Private sponsorship (foundations, study societies, etc.)
- Address:
- Christoph Dornier Stiftung für Klinische PsychologieSchorlemer Str. 4648143 MünsterGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- TransMIT-Geschäftsstelle Ethikkommission (im Auftrag der Deutschen Gesellschaft für Psychologie DGPs) [Ethikkommission der deutschen Gesellschaft für Psychologie (DGPs)]Prof. Dr. Gerhard StemmlerZur Weinstraße 1035041 MarburgGermany
- Telephone:
- +49 (0)6421 93056
- Fax:
- No Entry
- 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:
- 2020-12-14
- Ethics committee number:
- LangThomas2020-12-14VA
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-05-04
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?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll im Rahmen des Fast Tracks
- Study abstract:
- No Entry
- Other study documents:
- Abschlussbericht im Rahmen des Fast Tracks für digitale Gesundheitsanwendungen des Barm
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- 2024
- 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:
- Analyses confirmed significant group x time interaction effects for primary outcome (panic- and agoraphobia symptoms), and for one of the secondary outcomes (anxiety control). There were no effects for quality of life or impairment.