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临床试验/ISRCTN11129335
ISRCTN11129335进行中(未招募)未知

Enhancing the efficacy of CBT for patients with unipolar depression by integrating digital interventions into treatment: Results from a randomized controlled trial

Heinrich-Heine-Universität Düsseldorf0 个研究点目标入组 324 人开始时间: 2023年2月8日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
324

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
  • 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
  • F34.1: Dysthymia
  • 2. Between the age of 18 and 65 years
  • 3. Sufficient German language skills (in writing and reading)
  • 4. Possess a smartphone (iOS or Android operating system) with internet access
  • 5. Provide signed and dated informed consent, and be willing to comply with the protocol

排除标准

  • 1. All individuals without the included ICD-10 diagnoses as well as individuals with the following comorbid 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
  • 2. Individuals with acute suicidality (assessed via clinical assessment by the responsible therapist),
  • 3. Individuals without any access to a smartphone (iOS or Android operating system) with internet access, and
  • 4. Individuals with insufficient German language proficiency are excluded from this study
  • 5. If an individual is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study is not possible
  • 6. Participants will also be excluded for the respective measurement point if they fail to complete the study questionnaires within 14 days after having received them

研究者

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