Treating Comorbid Depression During Care Transitions Using Relational Agents (RA-CBT)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Pain; Chronic Illness; Comorbid Depression
• Intervention / Treatment: Other: Pre-Post Feasibility

Detailed Description

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.

The study investigators propose to automate delivery of AHRQ's RED-D intervention and extend it with integrated self-management education for patients with CHF or COPD and comorbid depression following hospitalization. This intervention will be delivered using Relational Agent (RA) technology. Relational agents are animated counselors that provide patients with virtual consultations by simulating face-to-face conversation with an empathic provider. RAs provide an ideal medium for the CBT intervention because of: 1) their demonstrated ability to address non-adherence; 2) empathic communication features; 3) the ability to tailor the intervention to the individual patient; 4) the study investigators' past work demonstrating that hospitalized patients with depressive symptoms report high acceptance of the RA; and 5) the potential to address mental healthcare access barriers. Similar efforts using RA technology are being explored by the US Department of Defense to address the burden of PTSD among war veterans.

Traditional CBT has been effective for medically ill patients but limited in its impact on physical symptom experiences and therefore quality of life and healthcare utilization. Cully et al have shown a brief, face-to-face CBT intervention integrating self-management education is more effective for medically ill patients in primary care for reducing depression symptoms and improving quality of life. The relational agent CBT (RA-CBT) system will include six modules tailored for chronically ill patients with comorbid depression, including key components of face-to-face CBT. The final session will include a follow up exit interview to understand the patinet participant's experience with the RA-CBT program and to evaluate the effectiveness of the RA-CBT agent. The final session will incorporate a quantitative questionnaire and a voluntary qualitative interview. The RA-CBT program will include the following topics: cognitive restructuring (identify behaviors, emotions, and thoughts associated with chronic disease and depression, evaluate them and identify more helpful ones), problem solving, behavioral activation, adherence with medical appointments and medication management, and disease self-management. The disease self-management module will address relaxation, sleep hygiene and physical symptom management. Each module will contain a homework component. The RA-CBT protocol will be empathic, reflective and interactive, enhancing the possibility to develop engagement, increase adherence, and establish a trusting relationship and therapeutic alliance. Whereas current cCBT users cannot ask questions, the study team's RA-CBT intervention will make use of psychosocial technology that will allow the RA to interact with and respond to questions that arise.

Drs. Bickmore, Jack and Mitchell have conducted a series of studies using RA technology for health education and behavior change, including inpatient education (AHRQ grant 1R18HS017196-01 and AHRQ RFTO "Communication- Focused Technologies") and counseling for patients of all levels of health literacy. Dr. Bickmore and his team at Northeastern University have extensive experience designing and implementing RA psychosocial technology that simulates face-to-face conversation that is sensitive to the qualities of CBT that help establish an empathetic relationship, honing the use of social interaction with conversational technology in order to build trust and a therapeutic alliance between the agent and patient. There are many reasons why RAs provide an effective medium for health communication with patients, especially those with limited health literacy. The human-computer interface relies minimally on text (as compared to current cCBT models) and uses the universally understood format of face-to-face conversation, making it accessible to patients with limited reading ability. Most importantly, RAs enhance recall of critical information through the use of nonverbal conversational behaviors (gesture, tone) by providing redundant channels for conveying semantic content in order to enhance the likelihood of message comprehension. In addition, all cultures have nonverbal means for marking emphasis (for example, eyebrow raising and 'beat' or 'baton' hand gestures in American English) that may highlight salient parts of a message. Unlike a pre-recorded video lecture, the study team's RA-CBT intervention provides a flexible and dynamic communication medium that relies on synthetic speech tailored to the patient and the discourse context using language dynamically assembled using a dialogue engine (i.e. use of the patient's name, medical record information, and other personally relevant information) that responds to the context of the conversation (i.e. the questions asked, patient responses during earlier sessions, etc.) Patient contributions to the dialogue are made by selecting what they want to say from a multiple choice menu, dynamically updated for each turn of the conversation (no natural language understanding of unconstrained text or speech is performed). Alternative technologies do not offer this adaptive, face-to-face encounter that accommodates patients' needs. This interface has been used by over 2,500 patients including many with no prior computer experience.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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:

1. over 18 years old,
2. and/or admitted to the general medical or cardiology service of BMC with primary diagnosis of CHF or COPD exacerbation
3. and/or patients of ambulatory care clinics, specialty care clinics and/or chronic pain groups of BMC Family Medicine Health Centers
4. and/ or patients of Behavioral Health in the Department of Family Medicine and/or BMC Family Medicine Health Centers
5. and/or participants recruited from BU/BMC ecommunications and community settings such as community centers, recreational centers, senior centers, and weight loss centers.
6. and/or have ever been diagnosed with any symptoms of chronic illness such as Chronic Heart Failure (CHF) and/or Chronic Obstructive Pulmonary Disease
7. speak English with health providers,
8. have access to a telephone
9. have permanent housing and/or are not housed within shelter programs
10. Live in the Boston area, and do not plan on leaving the Boston area for more than 2 weeks in the next 6 months
11. 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.

Exclusion Criteria:

• Using clear protocols, the study investigators will identify those who do not have indications for CBT amd will exclude:

  1. Under 18 years of age
  2. Unable to speak English with health providers
  3. 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).
  4. Those who are suicidal or homicidal,
  5. Those who are currently in police custody and/or incarcerated,
  6. 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.
  7. If they do not live in permanent housing and/or live in shelter programs,
  8. Those who are already engaged in psychotherapy
  9. Those who are currently pregnant or planning to become pregnant during the course of the study
  10. Those who are receiving current treatment for active cancer diagnosis or who have been diagnosed with sickle cell anemia.
  11. The study investigators will not approach those patients who are on neurosurgery, hematology/ oncology, and/or trauma service.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pre-Post Feasibility Testing; The pre-post feasibility testing/ intervention includes the use of tablet technology and cognitive behavioral therapy (CBT) for depression and self-management education for patients with chronic illness and/or chronic pain and depression. The pre-post feasibility testing phase will include 25 subjects. The total duration of pre-post feasibility testing will be 6 weeks upon the retrieval of the RA-CBT tablet and the inclusion of follow up questionnaires, quantitative exit interview, and/or an optional extended qualitative exit interview.

Other: Pre-Post Feasibility; The feasibility testing phase will include 25 subjects. Total duration of pre-post feasibility testing will be 6 weeks upon retrieval of the RA-CBT tablet and follow up questionnaires, quantitative exit interview, and/or an optional extended qualitative exit interview. The extended exit interview is a qualitative semi-formal interview focusing on gathering participant experiences working with the intervention, the barriers and facilitators encountered, as well as overall feedback for the pre-post feasibility study and the relational agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Depressive Symptoms as Measured by the PHQ-8	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.	Intervention Study Period (Six Weeks/ Six Modules)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Change in Health-related Quality of Life and Functional Status measured by the SF-12	A secondary outcome is a positive change in health-related quality of life and functional status measured by the Medical Outcomes Study Short Form 12 (SF-12), which has been validated in patients with CHF, COPD, chronic pain due to advanced osteoarthritis, inoperable spinal stenosis, and chronic headaches. The SF-12 will measure physical functionality, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well-being).	Intervention Study Period (Six Weeks/ Six Modules)
Increase in Patient Activation measured by the PAM-13	A secondary outcome is an increase in how activated the patient is in regards to their health and health care treatment, measured by the Patient Activation Measure (PAM-13).	Intervention Study Period (Six Weeks/ Six Modules)
Positive Change in Quality of Life Satisfaction measured by the Q-LES-Q-SF	A secondary outcome is a positive change in quality of life enjoyment and satisfaction measured by the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form.	Intervention Study Period (Six Weeks/ Six Modules)
Increase in Quality of Life Satisfaction measured by the WSAS	A secondary outcome is an increase in quality of life satisfaction measured by the Work and Social Adjustment Scale (WSAS).	Intervention Study Period (Six Weeks/ Six Modules)
Assessment of user attitude towards RA-CBT agent measured by WAI	A secondary outcome is assessment of users' attitudes towards working with the RA-CBT agent on health related goals using the Working Alliance Inventory (WAI).	Intervention Study Period (Six Weeks/ Six Modules)
Adherence to treatment with the RA-CBT technology measured by completion and engagement of tablet.	A secondary outcome includes the adherence to treatment with RA-CBT technology among intervention participants. There will be assessment of the proportion of participants who complete all 6 modules within 6 weeks. There will be examination of the proportion who failed to engage in treatment (<2 sessions or modules) and proportion who failed to complete treatment (>2 but <6). The study investigators will also examine the length of time that participants are engaged with the overall program, per module, and per bonus activity.	Intervention Study Period (Six Weeks/ Six Modules)
Assessment of Satisfaction of Treatment measured by the CSQ-8	A secondary outcome is the assessment of user's satisfaction with the intervention and relational agent measured by the Client Satisfaction Questionnaire (CSQ-8)	Intervention Study Period (Six Weeks/ Six Modules)

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Northeastern University
• Investigators: Principal Investigator: Suzanne E. Mitchell, M.D., M.S., Boston Medical Center

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): May 21, 2017
• Study Completion (Actual): May 21, 2017

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Chronic Pain; CBT; Cognitive Behavioral Therapy; Chronic Illness; Comorbid Depression; Relational Agent Technology; Virtual Counselor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Pain; Neurologic Manifestations; Disease Attributes; Depression; Depressive Disorder; Chronic Pain; Chronic Disease
• Other Study ID Numbers: H-32856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No