Treating Comorbid Depression During Care Transitions Using Relational Agents

NCT02845102 | Completed

• 1 other identifier: H-32856
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Illness; Chronic Pain; Depression; Comorbid Depression

Keywords

Chronic Illness; Chronic Pain; Depression; Comorbid Depression; Cognitive Behavioral Therapy; Relational Agent Technology; CBT; Virtual Counselor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• Positive Change in Quality of Life Satisfaction measured by the Q-LES-Q-SF

  Intervention Study Period (Six Weeks/ Six Modules)

• Increase in Quality of Life Satisfaction measured by the WSAS

  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)

Study Arms (1)

Pre-Post Feasibility Testing

EXPERIMENTAL

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

Interventions

Pre-Post Feasibility OTHER

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.

Pre-Post Feasibility Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Northeastern University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

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MeSH Terms

Conditions

Chronic Disease; Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Suzanne E. Mitchell, M.D., M.S.

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty, BMC

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 27, 2016
• Study Start: August 1, 2014
• Primary Completion: May 21, 2017
• Study Completion: May 21, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)