ISRCTN12481277
Active, not recruiting
未知
A randomized controlled study to evaluate a digital intervention for the treatment of anxiety disorders in adults
Elona Health GmbH0 sites158 target enrollmentJuly 6, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Treatment of anxiety disorders in patients on the waiting list for the outpatient psychotherapeutic treatment
- Sponsor
- Elona Health GmbH
- Enrollment
- 158
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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