Treating Comorbid Depression During Care Transitions Using Relational Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Decrease in Depressive Symptoms as Measured by the PHQ-8
研究概览
简要总结
Depression is common among individuals with chronic illness such as chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD) and is a strong predictor of poor clinical outcomes and high rates of avoidable 30-day readmissions. While depression is a treatable condition, few people with depression receive effective treatment. The proposed study aims to develop a relational agent system to deliver depression treatment to patients with chronic illness and comorbid depression. While depression is a treatable condition, less than 36% of people with depression receive effective treatment. The proposed study aims to design and develop a technology-driven relational agent system to deliver a 6 module, blended approach of cognitive behavioral therapy and self-management education (RA-CBT) to support patients with CHF or COPD and comorbid depression. The relational agent is a human animation program that interacts with patients, integrates best practices from provider-patient communication theory, emulating the face-to-face conversational behavior of an empathic provider emphasizing nonverbal communicative behavior such as gaze, posture, gestures, etc. The RA-CBT program will be accessed via tablet technology by participants. The study investigators will conduct a pre-post feasibility study to understand the feasibility and acceptability of using the RA-CBT system and its effectiveness in treating comorbid depression. If successful, this new approach to depression treatment would immediately expand access and scalability for post-discharge mental health support in the care transition.
详细描述
Depression is a treatable disorder with effective pharmacologic and psychotherapy options for treatment. Evidence suggests that psychotherapy interventions such as cognitive behavior therapy (CBT) and self-management education (Lorig) can improve depression, physical symptoms and quality of life in patients with chronic medical conditions.While depression is treatable, less than 36% of patients afflicted with mood disorders get treatment. In order to meet the imminent need for post-discharge mental health support for patients with chronic illness, innovative approaches to delivering mental healthcare that are accessible on short notice, are urgently needed. The study investigators now aim to translate the RED-D intervention to an automated system to expand immediate access and scalability for this support service.
Cognitive behavioral therapy for depression (CBT) and self-management education have been studied for the treatment of comorbid depression in chronically ill patients. CBT is a psychosocial intervention that posits that depressive symptoms occur when individuals have a dysfunctional view of themselves, the world and the future. CBT teaches techniques to examine dysfunctional beliefs that perpetuate depression and to develop more accurate and helpful ones to alleviate that condition. It has largely been documented that CBT is among the most effective treatments for depression and shown to be more effective than other psychosocial treatments, as effective as pharmacotherapy and as effective as adding another medication for patients who do not respond to one antidepressant alone. CBT has also been successfully used to treat comorbid depression; the ENRICHD trial demonstrated that a collaborative care approach, hinged on CBT, is an effective treatment for depressive symptoms among post MI patients and superior to usual care.
Several studies have also demonstrated the efficacy of self-management education. For example, Lorig et al showed that self-management education enhances self-efficacy and reduces health service utilization among patients with chronic illness. This and similar programs include key processes of identifying and addressing problems, problem solving skills training, action plan design, and applying skills to medical and psychosocial aspects of chronic illness. However, self-management education alone shows limited efficacy for chronically ill patients with significant depression.
A few interventions have combined CBT for depression with self-management support. Culley et al showed that a brief CBT intervention integrating self-management strategies reduced both depressive and dyspnea symptoms in a trial with veterans diagnosed with either CHF or COPD in a primary care setting. This evidence suggests a blended and brief skills-based approach to treatment that addresses both physical symptoms and depression is more effective for depressed patients with chronically illness. However, conventional CBT has limitations. Traditionally, CBT is delivered in a face-to-face format requiring a patient to meet with a therapist in an office setting for weekly sessions for 1 weeks or more. Adherence can be a barrier for CBT due to factors related to stigma, transportation, or access to trained CBT clinicians. This has led to trials of alternative formats for delivering CBT including both telephone delivered CBT and computer-based CBT (cCBT), both of which are shown to increase adherence to treatment compared with face-to-face CBT.
Many cCBT models are in use today because of their numerous technological advantages including cost effectiveness, increased access and flexibility, and also reduced stigma for those seeking treatment for mental health conditions. cCBT is also shown to be effective for people over the age of 50, suggesting that cCBT is feasible with older patients. However, there are still several limitations to cCBT that can impact efficacy. For example, current cCBT systems largely rely on textbased interactions, creating a potential literacy barrier for some users. Similar to face-to-face CBT, nonadherence is also a problem for cCBT. Sustained adherence is essential to reach a successful therapeutic outcome with cCBT. Yet, despite their promise, evidence shows that outside of clinical trial conditions, many cCBT users do not complete the intervention, thus adherence is still a problem, although cCBT systems with embedded adherence support messages such as weekly reminders have demonstrated higher rates of program completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study intervention will include both men and women admitted to Boston Medical Center in the last 24 hours. The study investigators will enroll those who are:
- •over 18 years old,
- •and/or admitted to the general medical or cardiology service of BMC with primary diagnosis of CHF or COPD exacerbation
- •and/or patients of ambulatory care clinics, specialty care clinics and/or chronic pain groups of BMC Family Medicine Health Centers
- •and/ or patients of Behavioral Health in the Department of Family Medicine and/or BMC Family Medicine Health Centers
- •and/or participants recruited from BU/BMC ecommunications and community settings such as community centers, recreational centers, senior centers, and weight loss centers.
- •and/or have ever been diagnosed with any symptoms of chronic illness such as Chronic Heart Failure (CHF) and/or Chronic Obstructive Pulmonary Disease
- •speak English with health providers,
- •have access to a telephone
- •have permanent housing and/or are not housed within shelter programs
- •Live in the Boston area, and do not plan on leaving the Boston area for more than 2 weeks in the next 6 months
- •are able to independently consent. If patients meet these criteria, the PHQ-2 will be administered during feasibility screening. Those who score ≥3 on the PHQ-2 during this pre-consent screening and will be consented. The PHQ-2 score will carry over into post-consent screening of the feasibility testing enrollment form.
- •The PHQ-8 will be administered post-consent during the enrollment process. Those who score ≥5 on the PHQ-8 and meet the other post-consent screening on the enrollment form will be enrolled in the study.
排除标准
- •Using clear protocols, the study investigators will identify those who do not have indications for CBT amd will exclude:
- •Under 18 years of age
- •Unable to speak English with health providers
- •Those who do not have indications for CBT (e.g., active substance abuse, dementia, bipolar disease, schizophrenia, psychotic symptoms, prior history of ECT, among others based on Mini International Neuropsychiatric Inventory).
- •Those who are suicidal or homicidal,
- •Those who are currently in police custody and/or incarcerated,
- •Those who do not live in the Boston (or MA) area, or those who plan on leaving the Boston area for more than 2 weeks in the next 6 months.
- •If they do not live in permanent housing and/or live in shelter programs,
- •Those who are already engaged in psychotherapy
- •Those who are currently pregnant or planning to become pregnant during the course of the study
- •Those who are receiving current treatment for active cancer diagnosis or who have been diagnosed with sickle cell anemia.
- •The study investigators will not approach those patients who are on neurosurgery, hematology/ oncology, and/or trauma service.
结局指标
主要结局
Decrease in Depressive Symptoms as Measured by the PHQ-8
时间窗: Intervention Study Period (Six Weeks/ Six Modules)
Primary outcome is the change in depression score measured by the PHQ-8 at the exit interview after the completion of the 6 weeks with the RA-CBT Program. The study investigators hypothesize that there will be a decrease in depressive symptoms at the end of 6 weeks or at the completion of the intervention.
次要结局
- Positive Change in Health-related Quality of Life and Functional Status measured by the SF-12(Intervention Study Period (Six Weeks/ Six Modules))
- Increase in Patient Activation measured by the PAM-13(Intervention Study Period (Six Weeks/ Six Modules))
- Assessment of Satisfaction of Treatment measured by the CSQ-8(Intervention Study Period (Six Weeks/ Six Modules))
- Positive Change in Quality of Life Satisfaction measured by the Q-LES-Q-SF(Intervention Study Period (Six Weeks/ Six Modules))
- Assessment of user attitude towards RA-CBT agent measured by WAI(Intervention Study Period (Six Weeks/ Six Modules))
- Increase in Quality of Life Satisfaction measured by the WSAS(Intervention Study Period (Six Weeks/ Six Modules))
- Adherence to treatment with the RA-CBT technology measured by completion and engagement of tablet.(Intervention Study Period (Six Weeks/ Six Modules))
研究者
Suzanne Mitchell
Faculty, BMC
Boston Medical Center
