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Evaluation of "Invirto Therapy" for people with panic disorder: a randomized-controlled trial

Evaluation of "Invirto Therapy" for people with panic disorder: a randomized-controlled trial - EvIP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027585
Enrollment
128
Registered
2022-01-13
Start date
2022-02-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F41.0 F40.01

Interventions

Group 1: Interventional = access to the app-based therapy "Invirto Therapy" Group 2: Control group = access to usual care
after 12 weeks (post-survey) access to the app-based therapy "Invirto Therapy"

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria: - Acute suicidal ideation - Diagnosis of schizophrenia or bipolar disorder

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactLena Jelinek

Universitätsklinikum Hamburg-Eppendorf

ljelinek@uke.de+49 (0)40 7410-55868

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026