跳至主要内容
临床试验/NCT06430476
NCT06430476招募中不适用

Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Montgomery-Åsberg Depression Rating Scale (MADRS)

研究概览

简要总结

To determine if a two-week ecological momentary intervention (two EMA + one EMI daily) as augmentation to treatment as usual would reduce depressive symptoms, rumination levels, and functioning in subjects with mild to moderate depression, as compared to active controls receiving three EMA prompts daily.

详细描述

Background:

Major Depressive Disorder (MDD) is the leading contributors to disability-adjusted life years, with a burden comparable to that of cardiovascular disease. Among the core symptoms of MDD, rumination stands out as a particularly pernicious factor. Rumination is dysfunctional disturbing thinking; a maladaptive pattern of regulating thoughts and emotions characterized by a repetitive focus on negative thoughts, such as dwelling on negative memories and analyzing events without taking actions. Rumination amplifies negative cognitions and attenuates the effect of adapting problem-solving strategy, decreasing the motivation of patients to cope with stressful encounters and become more vulnerable to momentary low mood. Interventional strategies (such as Cognitive Bias Modification) targeting rumination involves increases one's ability to become aware of their own rumination and supporting them to adapt alternative thinking habits. Complementary techniques such as mindfulness and relaxation do not involve the reframing of negative thoughts but rather promote the acceptance of these thoughts, in this way, it allows one become more aware of distractions and repetitive past or future thinking events. The ESM, a structured self-report diary technique several times a day over a number of days using mobile devices zooming in on the micro-level of experience and behavior, presents a novel and promising approach to accurately track symptoms and experience by minimizing recall bias and capturing the natural fluctuations of symptom on a more immediate, granular level. The ESM-derived intervention (ESM-I), uses personalized mobile feedback to effectively treat depressive symptoms. Importantly, increasing evidence from randomised controlled trials (RCTs) have shown ESM-I as effective means to augment interventions in depression. While improving rumination is key the core depression symptom, ESM-I has yet to specifically target rumination, and the mechanisms by which ESM-I exert therapeutic effects warrant further investigation.

Objectives:

Our study aims to investigate the efficacy of a newly developed smartphone based 2-week Ecological Momentary Intervention (EMI) in comparison with an active control group receiving only ESM, as an innovative, online-based, accessible, and augmentative treatment for depression. This intervention is designed to be both timely and adaptive, targeting the core symptom of anhedonia in a clinical sample within Hong Kong.

Design:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

masking: Participants will be notified that they would engage in a diary recording activity for two weeks, but would be blinded to whether they were receiving the intervention or active control version. Participants will also be instructed not to reveal their exercise components (i.e., relaxation exercises or rumination exercises) to the trained research assistants, who will also be responsible for obtaining outcomes. Trained research assistents would assess outcomes and the principal investigator would randomise participants to the two conditions based on anonymised IDs. Treatment provided to participants as usual by their usual care providers (e.g., doctors) would not be notified about the randomisation conditions.

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 16-65 years
  • Cantonese-speaking ethnic Chinese
  • Diagnosis of major depressive episode (MDE) established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorder 5th Edition (DSM-V)
  • 17-item Hamilton Depression Rating Scale (HDRS) ≥ 14 at screening and at baseline (i.e. moderate to severe depression)
  • Having a smartphone with Internet access and iOS or Android operating system.

排除标准

  • Patients who could not read Chinese, are unable to provide informed consents
  • Comorbid with other Axis I diagnoses (especially schizoaffective disorder)
  • With an unstable medical condition or current substance abuse
  • Have a score of ≥4 on any one of the three items on Positive and Negative Syndrome Scale (P1 Delusion, P2 Conceptual disorganization, P3 Hallucination)
  • Marked risk of self-harm or suicide that could not be safely managed in an outpatient clinic setting
  • Currently receiving any other weekly psychosocial therapy
  • Unable to use a smartphone-based application due to cognitive impairment or learning disability or inadequate vision.

结局指标

主要结局

Montgomery-Åsberg Depression Rating Scale (MADRS)

时间窗: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

Measuring change in depressive symptoms; score ranges from 0 (minimum) to 60 (maximum); higher score indicates more severe depressive symptoms.

Ecological Momentary Assessment (EMA) outcomes

时间窗: During intervention

Average score among the following aspects: positive and negative affect (four questions each), active and passive suicidality (one question each), rumination (four questions); score ranges from 0 (minimal) to 100 (maximum), with a higher score indicating a greater value of measured aspect.

次要结局

  • Beck Scale for Suicidal Ideation(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • Clinical Global Impression Scale(T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • Hamilton Depression Rating Scale (HDRS) - 17 items(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • Rumination Response Scale (RRS)(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • Role Functioning Scale (RFS)(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • Social and Occupational Functioning Assessment scale (SOFAS)(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • Global Functioning: Social Scale and Role Scale(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • WHO-5 Well-being Index(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • General Self Efficacy Scale(T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up))
  • System Usability Scale - Chinese version(T1 (immedately after intervention); T2 (one-month after intervention follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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