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临床试验/NCT04410770
NCT04410770Unknown2 期

Use of a Mood Tracker Smartphone App as a Chronic Health Management Intervention for Emotional Distress in Persons With TBI

Memorial Hermann Health System2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年4月23日最近更新:
适应症

试验速览

阶段
2 期
入组人数
126
试验地点
2
主要终点
Personal Health Questionnaire - 9 (PHQ-9) and Global Anxiety Disorder - 7 (GAD-7) scores combined.

研究概览

简要总结

Traumatic brain injury (TBI) is a common type of injury that affects thousands of people a year. TBI can cause a number of disabilities such as impaired cognition, decreased strength, decreased balance, problems controlling feelings, and difficulty communicating with others. Other problems that persons with TBI can have in the period after hospital discharge are anxiety and depress. These problems are common. At about one year after being injured, 44% of people have anxiety and 40% have depression. By five years after injury, 28% have depression and 17% have anxiety. If we think of emotional distress as having depression, anxiety, or both, at one year, 53% of people with TBI have emotional distress and, at five years, 38% have emotional distress. Many people with TBI are reluctant to seek help for emotional problems and when they do want help, it is hard to find. Many states have a shortage of mental health providers, many injured persons lack insurance that would pay for mental health treatment, and treatment may only be available a long distance from where people live.

In an attempt to address this problem, we are conducting a study designed to determine whether a self-management strategy can improve emotional distress or make emotional distress less like to develop. Previous studies have shown that simply keeping track of a problem may improve it. For example, tracking how often one has headaches can result in fewer headaches. Keeping track of one's blood pressure can lead to lower blood pressure. We are conducting this study to see if tracking one's level of emotional distress will result in lower levels of emotional distress. We are asking people with TBI to rate their levels of emotional distress several times a week using a special smart phone app. We will then conduct statistical tests to see if completing these ratings can cause people to have less emotional distress or prevent emotional distress from developing.

详细描述

Self-management Challenges for Persons with TBI:

A coordinated approach to chronic health management has been shown to be effective for a number of conditions such as asthma, (Wolf, et al., 2002) diabetes, (Glasgow, Funnell, et al., 2002) heart failure, (Glasgow, et al., 2002) and excess alcohol use (Hospital MM, Wagner, et al., 2016) among many others. Favorable results have been obtained across a wide range of clinical populations including adults (Glasgow et al., 2002) and children. (Hospital et al., 2016) The self-management aspect of chronic health management is often referred to as enablement. The patient is empowered to take action to improve his/her own health status. (Battersby, Von Korff, et al., 2010) Steps taken to facilitate this process are called self-management support. A wide range of self-management strategies have been used to improve health outcomes. These include skill-based training, goal setting, involvement with community based programs that provide education and support, self-monitoring, and use of technologies such as web-based content, text messages, graphic computer based feedback as opposed to verbal feedback, and others. (Battersby, Von Korff, et al., 2010) As reviewed in the Importance of the Problem section, persons with TBI have increased risk for a number of physical, cognitive, behavioral, and emotional co-morbidities that can decrease health and function, community living, and participation outcomes including employment. Given the limited availability and poor accessibility of psychiatric, psychological, counseling, and other mental health services, emotional distress is a particular concern for persons with TBI and their families. A number of studies have found that clinically significant emotional distress (defined here as depression, anxiety, or co-morbid depression and anxiety) is common after TBI. Depression and anxiety are more common in persons with TBI than in persons without TBI across all age ranges and all injury severities. (Osborn, Mathias, et al., 2016; Dikmen, Bombardier, et al., 2004) While anxiety may be more common early post-injury, depression is more problematic in the later years post-injury. (Always, Gould, et al., 2016) In this study, 40.1% of persons with TBI met diagnostic criteria for a depressive disorder at one year post-injury, while 44.1% had an anxiety disorder. By 5 years post-injury, 27.7% had depression and 16.8% had anxiety. If psychological distress is operationalized as anxiety, depression, or both, at year 1, 53.3% had psychological distress and at year 5, 33.7% had psychological distress. Anxiety and depression after TBI are associated with decreased social participation, limited independence in community living, decreased participation including employment, and low life satisfaction.

The frequent occurrence and negative impact of emotional distress after TBI is compounded by limited availability of mental health care providers and limited ability to access mental health services due to inability to pay and attitudinal barriers. Persons without TBI face challenges in obtaining mental health care. Findings from the National Comorbidity Survey Replication of 9,282 persons selected to represent the general population of the U.S. indicated that 1,350 (14.5%) met diagnostic criteria for a psychiatric disorder. Of these, 783 did not seek care for their psychiatric symptoms. (Mojtabi, Olfson, et al., 2011) Of those not seeking care, 44.8% did not perceive that they needed mental health services even though they met diagnostic criteria. The remaining 55.2% perceived that they needed care, but did not seek care due to various barriers. Structural barriers included inadequate financial resources, limited availability of providers, lack of transportation, and perceived inconvenience. Attitudinal barriers were experienced by about 4 times as many persons as structural barriers. Attitudinal barriers included perceived ineffectiveness of mental health services, stigma, and others. (Mojtabi, et al., 2011) These findings are of particular concern for our Center that serves the greater Houston metropolitan area, outlying areas in Texas, and various out of state and international constituencies. As reviewed in Section A - Importance of the Problem, Texas ranks in the lower 10% of all states in access to mental health care, persons needing mental health services who have insurance, and availability of mental health providers. (Mental Health in America, 2017) Poor accessibility of mental health services due to poor availability, cost of care, and various attitudinal barriers indicates the need for alternative service delivery models. Some encouragement is provided by a recent study (Bernecker, Banschback, et al., 2017) that found that of persons who needed mental health interventions but indicated that they would not use traditional psychotherapy even if they had an available provider and ability to pay, 51% indicated that they would be open to trying a web-based utility that would provide self-help and peer-support. Persons with TBI are even more challenged in accessing mental health services than the general population due to having more limited transportation options, being less likely to have healthcare coverage, and an even greater shortage of specialized providers.

Use of Technologic Solutions to Provide Mental Health Services in the Context of Health Management and Treatment of Emotional Distress in Persons with TBI:

The chronic health management literature provides a number of examples of electronic technologies used to support patient use of self-management strategies. In an intervention to decrease underage drinking, teens received text messages providing information about negative consequences of alcohol use, prompts to enhance self-efficacy, and social support. (Hospital et al., 2016) Teens receiving these messages showed greater interest in decreasing alcohol use than those who received control messages. A web based program was used to increase patient behavioral activation in an effort to increase self-management behaviors in a cohort including persons with asthma, hypertension, or diabetes. (Solomon, Wagner, Goes, 2012) Patients receiving this intervention showed greater increases in behavioral activation as indicated by higher self-efficacy and more regular tracking of health indicators such as medication compliance, glucose levels, and blood pressure than those not receiving the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The clinical coordinator screens, consents, and completes baseline assessments with the participants. The clinical coordinator passes on the participants to the counselor who completes the support calls. The clinical coordinator and the counselor are unmasked. The participant is unmasked as he/she is aware of when he/she is receiving the support calls and when he/she is not. The 6 and 12 week outcomes are collected by a separate research assistant who is masked. The investigators are not exposed to the randomization process and are unaware of which arm the participant is assigned to.

入排标准

年龄范围
18 Years 至 62 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically documented complicated mild, moderate, or severe TBI
  • Previous assent to be contacted regarding TBI related studies
  • One year or greater post-injury
  • Age 18 to 62 years at time of screening
  • Adequately fluent in English to complete an interview and all study measures
  • Living in a residential setting in the community
  • Has capacity to give consent to medical research
  • Access to a smartphone with capacity to download and run the T2 Mood Tracker app
  • Acknowledges some degree of emotional distress

排除标准

  • Has capacity to give consent to medical research
  • Access to a smartphone with capacity to download and run the T2 Mood Tracker app
  • Acknowledges some degree of emotional distress

结局指标

主要结局

Personal Health Questionnaire - 9 (PHQ-9) and Global Anxiety Disorder - 7 (GAD-7) scores combined.

时间窗: 6 weeks from baseline.

Scores for the PHQ-9 range from 0 to 27 with higher scores indicating greater depression. Scores for the GAD-7 range from 0 to 21 with higher scores indicating greater anxiety. These are measures of depression and anxiety that were developed for public health research. Scores from the 2 measures are combined to form an index of emotional distress.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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