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临床试验/NCT02846662
NCT02846662已完成3 期

Randomized Clinical Trial to Evaluate the Effectiveness of an Intervention Using Mobile Technology for the Treatment of Depressive Symptoms in People With Diabetes or Hypertension

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2016年9月19日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
880
试验地点
2
主要终点
Number of participants with 50% reduction in PHQ-9 score a 3-month assessment

研究概览

简要总结

Background: Depression is a usual comorbid event associated to chronic diseases, such as hypertension and diabetes, constituting an important public health problem, with negative consequences for patients' quality of life and self-care, as well as for compliance with medical treatment. In low and middle income countries depression is often unrecognized and untreated, and there is a lack of human resources to treat depression and other mental problems in these health care systems.

Aim: The present study aims to test a 6 week low-intensity psychological intervention (CONEMO) delivered via an applicative for smartphones for people with depressive symptoms and co-morbid diabetes and/or hypertension recruited in primary health care units, in São Paulo (Brazil).

详细描述

Epidemiologic research has clearly established the significant public health importance of mental disorders in low- and middle-income countries (LMIC) and their chronic nature. Among mental disorders, depression has become a major problem as a single condition and, more often, as part of complex clinical pictures in which multiple conditions and risk factors are combined.

There is substantial co-morbidity between depression and chronic physical conditions, and outcome of both conditions is impaired when there is this co-morbidity. Most of the disease burden in LA is now explained by chronic diseases, including depression, cardio-vascular diseases -mostly hypertension related- and diabetes. Despite the public health impact of depression, it often goes unrecognized and untreated. One factor for this treatment gap is the lack of financial and human resources. The limited mental health resources available in LMIC are often not optimally distributed either. Funds and trained personnel are typically allocated in tertiary health care services, such as psychiatric hospitals.

Therefore, any short- and medium-term efforts to develop, evaluate, and disseminate effective mental health interventions in LMIC must adapt to these severe workforce, resource limitations, and inequities. The mental health field needs to consider developing self-help automated interventions that can reach people where there are no health care providers. This can be partially addressed through two strategies: 1) increasing effective self-management; and 2) through task-shifting roles to less specialized but appropriately trained health workers.

We are conducting a community cluster randomized trial with individuals with chronic diseases (hypertension and/or diabetes) and symptoms of depression, attending primary care clinics in São Paulo, Brazil. Participating clinics (20) will be randomly allocated to have their nurse assistants trainned and supervised to monitor an intervention based on behavior activation (experimental group) delivered by an applicative for smartphones (CONEMO) or to receive routine care (control group). The focus of this project is on patients helping themselves through the use of resources that provide continuous advice, support, and motivation. However, studies suggest that depressed patients left alone with their own devices fail to make good use of self-help interventions. Nurse assistants will assist participants by a web-based automated interface connected to the smartphone application (CONEMO) and will receive supervision in this task once a week.

Method:

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Attending one of 20 selected primary care clinics
  • Clinical diagnosis of diabetes and/or hypertension
  • Presenting with depressive symptoms (PHQ-9 ≥10)

排除标准

  • Moderate to high suicidal risk (assessed with a standardized protocol)
  • Not able to read

研究组 & 干预措施

CONEMO

Experimental

Participants will be offered a behavioral activation-based intervention delivered by an applicative for smartphones (CONEMO), which encourages them to be more active and to incorporate more activities in their everyday life.

Primary care nurses will train participants to use the CONEMO app, monitor patients' adherence to CONEMO, calling patients when they are non-adherent, and give technical support when necessary. They will be supervised by clinical psychologists.

Primary care teams are informed of participants' depression level and deliver usual care according to clinical protocols, including the assessment for the need of antidepressant medication.

干预措施: CONEMO (Behavioral)

ENHANCED USUAL CARE

No Intervention

The primary care teams are informed of the participants' depression level and can deliver usual care according to clinical protocols, including the assessment for the need of antidepressant medication. This is considered enhanced usual care because the teams are notified about participants' level of depressive symptomatology, which otherwise might go undetected, and then decide about the best way to handle with patients' needs related to their depressive symptomatology.

结局指标

主要结局

Number of participants with 50% reduction in PHQ-9 score a 3-month assessment

时间窗: 3 months after enrollment

Presence and severity of depressive symptoms is measured with the PHQ-9. A 50% reduction in PHQ-9 score at 3-month assessment as compared to PHQ-9 score at baseline will be considered as treatment success.

次要结局

  • Number of medical consultations, hospitalizations, and visits to the primary care team(3 and 6 months after enrollment)
  • Proportion of participants who improve level of activity, as evaluated by the short form of the Behavioral Activation for Depression Scale (BADS)(3 and 6 months after enrollment)
  • Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire(3 and 6 months after enrollment)
  • Number of participants with 50% reduction in PHQ-9 score a 6-month assessment(6 months after enrollment)
  • Improvement in scores for Quality of Life, as measured by the EQD5(3 and 6 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Rossi Menezes

Full Professor

University of Sao Paulo General Hospital

研究点 (2)

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