A randomized controlled study to evaluate a digital intervention for the treatment of anxiety disorders in adults

Elona Health GmbH0 个研究点目标入组 158 人开始时间: 2023年7月6日最近更新: 2023年7月18日

适应症

试验速览

暂无简介。

•All subjects must have been diagnosed with one of the following ICD-10 diagnoses:
•F40.00: Agoraphobia: Without history of panic disorder
•F40.01: Agoraphobia: With panic disorder
•F40.1: Social phobia
•F41.0: Panic disorder (episodic paroxysmal anxiety)
•Subjects further need to:
•1. Be at least 18 years old
•2. Possess sufficient German language skills (in writing and reading)
•3. Possess a smartphone (iOS or Android operating system) with internet access
•4. Provide signed and dated informed consent and be willing to comply with the protocol

•All subjects without the inclusion ICD-10 diagnosis criteria, as well as subjects with the following ICD-10 diagnoses, are excluded:
•F00-F09: Organic, including symptomatic, mental disorders
•F10-F19 Mental and behavioural disorders due to psychoactive substance use (except F17.1, F17.2, F17.3)
•F20-F29: Schizophrenia, schizotypal and delusional disorders
•F30: Manic episode
•F31.0, F31.1, F31.2, F31.5, F31.6, F31.8, F31.9: Bipolar disorder current hypomanic or manic episode
•F32.3: Severe depressive episode with psychotic symptoms
•F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms
•1. Subjects with acute suicidality (assessed via suicidality screening of the mini-DIPS at the initial screening)
•2. Subjects under the age of 18, subjects without any access to a smartphone (iOS or Android operating system) with internet access
•3. Subjects without German language proficiency
•If a subject is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study needs to be pre-approved by the principal investigator.

发起方

Elona Health GmbH