Treating Comorbid Depression During Care Transitions Using Relational Agents

Completed · Not applicable

Conditions studied: Chronic Illness, Chronic Pain, Depression, Comorbid Depression

In brief

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.

Key facts

Study ID: NCT02845102
Run by: Boston Medical Center
People needed: 4
Starts: 2014-08-01
Expected to finish: 2017-05-21
Last updated by the study team: 2017-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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