Evaluation of "Invirto Therapy" for people with panic disorder: a randomized-controlled trial
Organizational Data
- DRKS-ID:
- DRKS00027585
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-01-13
- Last update in DRKS:
- 2024-01-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
EvIP
URL of the study
No Entry
Brief summary in lay language
The aim of the planned study is to investigate the efficacy of the app-based therapy "Invirto Therapy". The study will randomly assign 128 individuals diagnosed with panic disorder with a duration of at least one year to two groups (Invirto Therapy vs. Care as usual). All participants will be assessed at three points in time using self-assessment questionnaires (online assessment). It is expected that the improvement in anxiety symptoms, depression symptoms, psychological flexibility, and quality of life will be larger in the Invirto Therapy group than in the control group.
Brief summary in scientific language
The 12-month prevalence for anxiety disorders is 15.4%, and a total of more than 10 million people are affected in Germany (Jacobi et al., 2014). Affected individuals suffer from decreased quality of life and mobility. For the EU, the costs for all ICD-10 F4x diagnoses in 2010 are estimated at 74 billion euros (Klosterkötter & Maier, 2017). Psychotherapy is considered effective and efficient for the treatment of anxiety disorders. However, many people with anxiety disorders do not receive guideline-based treatment due to various treatment barriers (Heinig et al., 2019). Digital therapy approaches offer low-threshold access, high cost-effectiveness and adaptivity, and a variety of benefits to counteract treatment barriers in anxiety disorder care. Accordingly, numerous studies confirm the effectiveness of digitally delivered psychotherapies (e.g., meta-analyses and reviews by Andersson et al., 2018; Christ et al., 2020; Stefanopoulou et al., 2019). To improve psychotherapeutic care for anxiety disorders, the app-based "Invirto Therapy" was developed (Sympatient GmbH). "Invirto Therapy" represents a digital intervention using international treatment guidelines for panic disorder (behavioral therapy). The planned study will investigate the efficacy of "Invirto Therapy" on a reduction of anxiety symptoms (primary endpoint), improvement of the level of functioning in everyday life and general health as well as quality of life over a period of three-month. For this purpose, 128 individuals with a diagnosis of panic disorder as determined by professionals of at least one year will be randomly assigned to the Invirto Therapy or the control group with "care as usual". The survey will be conducted via QUALTRICS. The Invirto Therapy group will receive access to the three-month intervention of Invirto Therapy after the assessment at baseline (T0), and the control group will receive access to Invirto Therapy after the second assessment 12 weeks later (T1). In addition, a follow-up survey (T2; six months after baseline) is planned. As compensation participants receive 60€. Besides health-related variables (anxiety symptomatology, depressive symptoms, psychological flexibility, global functioning, and quality of life), potential side effects and satisfaction with the app-based therapy will also be assessed. We expect that people receiving Invirto Therapy would have a larger improvement compared with the control group in both the primary end point (change in the sum score of BAI) and the secondary end points (change in the sum scores of PAS, BDI, AKV, FAH-II, and TAPQ and the mean score of WHO-QOL-BREF).
Health condition or problem studied
- ICD10:
- F41.0 - Panic disorder [episodic paroxysmal anxiety]
- ICD10:
- F40.01
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Interventional = access to the app-based therapy "Invirto Therapy"
- Arm 2:
- Control group = access to usual care; after 12 weeks (post-survey) access to the app-based therapy "Invirto Therapy"
Endpoints
- Primary outcome:
- Reduction of anxiety symptoms (sum score), measured by the Beck Anxiety Inventory (BAI; Margraf & Ehlers, 2007) at T0 (Baseline), T1 (3 months later), T2 (6 months later). We expect a larger decrease in the BAI in the intervention group from T0 to T1 compared to the conrol group. In the control group we expect a decrease in the BAI from T1 to T2.
- Secondary outcome:
- Panic and Agoraphobia Scale (PAS): The PAS measures the severity of symptoms in patients with panic disorder with or without agoraphobia within the past week. Thirteen items are used to assess five domains that limit quality of life in patients with panic disorder: panic attacks, agoraphobic avoidance, anticipatory anxiety, restriction, and health fears (T0, T1, T2). Body-related Anxiety, Cognition, and Avoidance Questionnaire (AKV): The AKV measures various aspects of symptomatology in patients with anxiety disorders and psychosomatic or functional complaints (T0, T1, T2). Beck Depression Inventory-II (BDI-II): The BDI-II is a self-report questionnaire for assessing the severity of depression (T0, T1, T2). The Questionnaire for acceptance and action (FAH-II): The FAH-II measures psychological flexibility (T0, T1, T2). Treatment Adherence Perception Questionnaire (TAPQ): The TAPQ measures patients' adherence to learned strategies. Originally developed for the somatic domain, we adapted the questionnaire for the psychiatric domain and specifically for our study (T1, T2). Quality of Life – global item (WHO-QOL-BREF): global item of the self-assessment questionnaire that measures quality of life (T0, T1, T2). Questionnaire for measuring patient satisfaction (ZUF-8): The ZUF-8 is a self-report questionnaire for measuring satisfaction with treatment (T1, T2). Fragen zur Zufriedenheit werden ergänzt durch Fragen zur Nutzung der Intervention. Therapy Measures Questionnaire: The Therapy Measures Questionnaire assesses which other therapeutic measures (e.g., depth psychology-based therapy) patients participated in during the study as well as the success of self-directed and therapist-directed exposures and their number (T1, T2). Positive and Negative Effects of Psychotherapy Scale; PANEPS-I: The PANEPS-I (Baumeister & Moritz, in press) is a newly developed scale to assess desirable and undesirable side effects of internet interventions. The scale is based on the Positive and Negative Effects of Psychotherapy Scale (PANEPS), a revised and shortened version of the Side-effects of Psychotherapy Scale (SEPS, Moritz et al., 2015). Contacts to the care system: Contacts to the care system (e.g., of (partially) inpatient admissions, somatic clarifications) (T1, T2). Subjective evaluation of adherence measures (intervention group only) (T1, T2).
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- 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):
-
- Other sympatient Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2022-02-01
- Actual study start date:
- 2022-02-08
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-06-17
- Target Sample Size:
- 128
- Final Sample Size:
- 124
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- - Presence of a primary diagnosed panic disorder in the past (ICD diagnosis by the physicians/psychologists) of at least one year - Consent to participate in the study - Informed consent to participate in "Invirto Therapy" and three online assessments - Presence of Internet access and a device to use "Invirto Therapy" - Sufficient understanding of the German language - Willingness to use "Invirto Therapy" on their own responsibility
Exclusion Criteria
- Acute suicidal ideation - Diagnosis of schizophrenia or bipolar disorder
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Lena JelinekMartinistraße 5220246 HamburgGermany
- Telephone:
- 0405741055868
- Fax:
- 0405741057566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://uke.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Dr. Lena JelinekMartinistraße 5220246 HamburgGermany
- Telephone:
- +49 (0)40 7410-55868
- Fax:
- +49 (0)40 7410-57566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Contact for Public Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Dr. Lena JelinekMartinistraße 5220246 HamburgGermany
- Telephone:
- +49 (0)40 7410-55868
- Fax:
- +49 (0)40 7410-57566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Principal Investigator
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Dr. Lena JelinekMartinistraße 5220246 HamburgGermany
- Telephone:
- +49 (0)40 7410-55868
- Fax:
- +49 (0)40 7410-57566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Hamburg-EppendorfMartinistraße 5220246 HamburgGermany
- Telephone:
- +49 (0)40 7410-55868
- Fax:
- +49 (0)40 7410-57566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Ethics Committee
Address Ethics Committee
- Address:
- Lokale Psychologische Ethikkommission am Zentrum für Psychosoziale Medizin (LPEK) Universitätsklinikum Hamburg-EppendorfMartinistraße 5220246 HamburgGermany
- Telephone:
- +49 (0) 40 7410 - 0
- 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:
- 2021-12-03
- Ethics committee number:
- LPEK-0415
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-12-21
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:
- only upon request
Study protocol and other study documents
- Study protocols:
- Schultz J, Baumeister A, Schmotz S, Moritz S, Jelinek L. Efficacy of an Internet-based intervention with self-applied exposure therapy in virtual reality for people with panic disorder: study protocol for a randomized controlled trial. Trials. 2023 Aug 12;24(1):521. doi: 10.1186/s13063-023-07536-1. PMID: 37573377; PMCID: PMC10422760.
- 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