ISRCTN16328317已完成未知
Pilot study to evaluate a digital health application for the blended treatment of unipolar depression and anxiety disorder in adults
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 200
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
- •1. All participants must have been diagnosed with one of the following ICD-10 diagnoses:
- •F32: Depressive episode
- •F32.0: Mild depressive episode
- •F32.1: Moderate depressive episode
- •F32.2: Severe depressive episode without psychotic symptoms
- •F32.8: Other depressive episodes
- •F32.9: Depressive episode, unspecified
- •F33: Recurrent depressive disorder
- •F33.0: Recurrent depressive disorder, current episode mild
- •F33.1: Recurrent depressive disorder, current episode moderate
- •F33.2: Recurrent depressive disorder, current episode severe without psychotic symptoms
- •F33.8: Other recurrent depressive disorders
- •F33.9: Recurrent depressive disorder, unspecified
- •F34: Persistent mood [affective] disorders
- •F34.0: Cyclothymia
- •F34.1: Dysthymia
- •F34.8: Other persistent mood [affective] disorders
- •F34.9: Persistent mood [affective] disorder, unspecified
- •F40.0 Agoraphobia
- •F40.00 Agoraphobia without panic disorder
- •F40.01 Agoraphobia with panic disorder
- •F40.1 Social phobias
- •F40.2 Specific (isolated) phobias
- •F40.8 Other phobic anxiety disorders
- •F40.9 Phobic anxiety disorder, unspecified
- •F41.0 Panic disorder [episodic paroxysmal anxiety]
- •F41.1 Generalized anxiety disorder
- •F41.2 Mixed anxiety and depressive disorder
- •F41.3 Other mixed anxiety disorders
- •F41.8 Other specified anxiety disorders
- •F41.9 Anxiety disorder, unspecified
- •F45.2 Hypochondriacal disorder
- •2. Participants need to be between the age of 18 and 65 years
- •3. Participants need to possess sufficient German language skills (in writing and reading)
- •4. Participants need to possess a smartphone (iOS or Android operating system) with internet access
- •5. Participants need to provide signed and dated informed consent and are willing to comply with the protocol
排除标准
- •1. All participants without the inclusion ICD-10 diagnosis criteria as well as participants with the following ICD-10 diagnoses are excluded:
- •1.1. F0x.x: Organic, including symptomatic, mental disorders
- •1.2. F1x.x Mental and behavioural disorders due to psychoactive substance use (except F17.x)
- •1.3. F2x.x: Schizophrenia, schizotypal and delusional disorders
- •1.4. F31: Bipolar affective disorder
- •1.5. F32.3: Severe depressive episode with psychotic symptoms
- •1.6. F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms
- •2. Individuals with acute suicidality (operationalized via BDI-II screening question greater than 1 or first checkup) are excluded from this study first checkup)
- •3. Participants under the age of 18 years
- •4. Participants without any access to a smartphone (iOS or Android operating system) with internet access
- •5. Participants without German language proficiency
- •If a participant 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
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