ISRCTN18035062进行中（未招募）Unknown
A feasibility and effectiveness trial to evaluate a digital intervention for the treatment of unipolar depression in adults
Elona Health GmbH0 个研究点目标入组 40 人开始时间: 2023年12月20日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All subjects must have been diagnosed with one of the following ICD-10 diagnoses:
- •F32.0: Mild depressive episode
- •F32.1: Moderate depressive episode
- •F32.2: Severe depressive episode
- •F33.0: Recurrent depressive disorder, current episode mild
- •F33.1: Recurrent depressive disorder, current episode moderate
- •F33.2: Recurrent depressive disorder, current episode severe
- •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
排除标准
- •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 who are currently enrolled or are planning to participate in a potentially confounding drug or device trial during the study
- •3. Subjects who are currently undergoing psychotherapy treatment (except consultation hours)
- •4. Subjects who intend to discontinue or change the dose of a psychopharmacological medication currently being taken or start a new psychopharmacological treatment in the next 10 weeks
- •5. Subjects who use another digital health application intended for mental health disorders
- •6. Subjects under the age of 18 years, subjects without any access to a smartphone (iOS or Android operating system) with internet access
- •7. Subjects without German language proficiency
研究者
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