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临床试验/NCT04986969
NCT04986969已完成不适用

Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Coronary Heart Disease

Debra Moser2 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Debra Moser
入组人数
444
试验地点
2
主要终点
Change in depressive symptoms as a result of intervention effects

研究概览

简要总结

Individuals with heart disease and depressive symptoms suffer from higher death rates, higher rates of acute cardiac events (such as heart attacks), and faster progression of heart disease compared to those with heart disease who do not have depressive symptoms, and these problems are much worse in rural people. Unfortunately, rural people with heart disease and depressive symptoms do not receive needed therapy for depressive symptoms because of lack of mental health providers in rural areas, worries about stigma, and difficulty accessing mental health care because of multiple barriers to traveling to get care. To overcome these barriers, the investigators will compare the impact of two types of online cognitive behavioral therapy (video-conferenced face-to-face versus self-administered internet-based) and usual care on depressive symptoms to provide patients and healthcare providers with needed information about which is more effective and to increase the number of patients adequately treated.

详细描述

Rural areas are noted for marked disparities in mortality, cardiovascular health, and access to health care. Prevalence rates for both coronary heart disease (CHD) and depressive symptoms in rural areas are higher than in urban areas. These facts are important because CHD patients experience high rates of depressive symptoms, which are associated with increased risk of getting and dying from CHD. Unfortunately, rural people with CHD and depressive symptoms do not receive needed therapy for depressive symptoms because of lack of mental health providers in rural areas, worries about stigma leading to treatment avoidance, and difficulty accessing mental health care because of barriers to travel to get care. Cognitive behavioral therapy (CBT), reduces depressive symptoms in CHD patients, but in its traditional form (in-person meetings of patient and therapist), CBT is resource-intensive and inaccessible to most rural patients. Wireless internet technology has the potential to make CBT more user-friendly, and accessible to rural patients. There has been a proliferation of alternative, internet-based, remote-delivery CBT interventions recently. The permutations of remote-delivery CBT fall under two categories - real-time, face-to-face, video-conferenced CBT (vcCBT) and self-administered internet-based CBT (iCBT). It is unclear which category of these delivery modalities is more effective. Determining which treatment option is more effective for treating depressive symptoms in rural patients with CHD and depressive symptoms will identify an easily accessible treatment option for rural patients. Using a randomized, controlled, stratified (by sex) design, the investigators will compare vcCBT, iCBT and usual care in rural CHD patients on the primary outcome of depressive symptoms over time. In addition, the investigators will determine whether intervention adherence, satisfaction or acceptability moderate treatment effects. The investigators will also assess whether sex or stigma moderate intervention effects to determine whether effectiveness of treatment option varies by sex or stigma level. Data about outcomes will be collected at baseline, 3 months, 6 months, and 12 months and provide important information about the trajectory of outcomes. Results from this study will provide new knowledge about which approach to treating depressive symptoms in rural CHD patients is more effective to improve decision-making in patients and healthcare providers, and increase the number of patients properly treated.

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
Single (Investigator)

盲法说明

Active therapy is delivered to patients, thus it is impossible to mask the participant or care provider. The investigators are blinded.

入排标准

年龄范围
21 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least moderate depressive symptoms (PHQ-9 ≥ 10)
  • rural dwelling
  • has had physician-documented acute coronary syndrome (ACS) event

排除标准

  • cognitive impairment
  • major psychiatric comorbidities, which might require additional treatment
  • presence of non-CHD conditions likely to be fatal within next year.

结局指标

主要结局

Change in depressive symptoms as a result of intervention effects

时间窗: Baseline, 3, 6 and 12 months

Change in levels of depressive symptoms measured using the Patient Health Questionnaire-9, across time and between subjects. The Patient Health Questionnaire-9 is a measure that consists of nine items that correspond to criteria for diagnosing depression. Higher scores indicate greater severity of symptoms. Scores on measure can range from 0-27 with an accepted cut-off of ≥ 10 for moderate symptoms. Reliability and validity of the instrument have been established in a variety of populations, including cardiac patients.

Change in intervention effects on depressive symptoms moderated by perceived stigma

时间窗: Baseline, 3, 6, and 12 months

The investigators will determine whether perceived stigma moderates intervention effects on depressive symptoms across time. Stigma refers to negative beliefs about a condition and its treatment. Depression-related stigma will be measured using the Depression Stigma Scale. Developed to measure personal stigma related to being treated for depressive symptoms, the measure has been used extensively since its inception. Scores on the 18-item total scale can range from 0-36, and higher scores indicate greater perceptions of stigma. The instrument has well-established reliability and validity, and has been used in rural Kentuckians.

Change in intervention effects on depressive symptoms moderated by sex

时间窗: Baseline, 3, 6, and 12 months

The investigators will determine whether sex moderates intervention effects on depressive symptoms across time. Sex will be self-described by the patient.

次要结局

  • Compare physical activity levels between groups(12 months)
  • Change in intervention effects on depressive symptoms moderated by health literacy(Baseline, 3, 6, and 12 months)
  • Compare all-cause hospitalization rates between intervention groups(12 months)
  • Compare medication adherence between groups(12 months)
  • Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety(12 months)

研究者

发起方
Debra Moser
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Debra Moser

Professor and Linda C Gill Endowed Chair of Nursing

University of Kentucky

研究点 (2)

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