AzTrials
AzTrials

Chronic IllnessRA-CBTNCT02845102

Treating Comorbid Depression During Care Transitions Using Relational Agents

A study testing Pre-Post Feasibility in people with Chronic Illness and Chronic Pain, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Illness, Chronic Pain, Depression
What is being tested?
Pre-Post Feasibility
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Aug 2014to 21 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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,
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pre-Post Feasibility
Keywords
Chronic Illness, Chronic Pain, Depression, Comorbid Depression, Cognitive Behavioral Therapy, Relational Agent Technology, CBT, Virtual Counselor
Medical subject headings
Chronic Disease, Chronic Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-Post FeasibilityOther

    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.

Study groups in NCT02845102
Study groupRoleWhat they receive
Pre-Post Feasibility TestingExperimentalThe 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.
Receives: Other: Pre-Post Feasibility

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

Secondary outcomes (7)
  1. 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).

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

  2. 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).

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

  3. 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.

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

  4. 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).

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

  5. 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).

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

  6. 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.

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

  7. 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)

    Measured: Intervention Study Period (Six Weeks/ Six Modules)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startAug 2014
  3. Primary completion21 May 2017
  4. Study completion21 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845102
Sponsor's protocol ID
H-32856
Acronym
RA-CBT
Status last verified
May 2017
First submitted
18 Jul 2016
Last updated
1 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.

    PubMed 19339721
  • Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007.

    PubMed 19189907
  • Mitchell SE, Paasche-Orlow MK, Forsythe SR, Chetty VK, O'Donnell JK, Greenwald JL, Culpepper L, Jack BW. Post-discharge hospital utilization among adult medical inpatients with depressive symptoms. J Hosp Med. 2010 Sep;5(7):378-84. doi: 10.1002/jhm.673.

    PubMed 20577971
  • Owens P, Myers M, Elixhauser A, Brach C, eds. Care of Adults with Mental Health and Substance Abuse Disorders in U.S. Community Hospitals, 2004. HCUP Factbook No. 10 Publication No. 07-0008; 2007.

  • Silver MA. Depression and heart failure: an overview of what we know and don't know. Cleve Clin J Med. 2010 Jul;77 Suppl 3:S7-S11. doi: 10.3949/ccjm.77.s3.02.

    PubMed 20622081
  • Sullivan M, Simon G, Spertus J, Russo J. Depression-related costs in heart failure care. Arch Intern Med. 2002 Sep 9;162(16):1860-6. doi: 10.1001/archinte.162.16.1860.

    PubMed 12196084
  • Dowson CA, Town GI, Frampton C, Mulder RT. Psychopathology and illness beliefs influence COPD self-management. J Psychosom Res. 2004 Mar;56(3):333-40. doi: 10.1016/S0022-3999(03)00040-0.

    PubMed 15046971
  • Cuijpers P, van Straten A, van Oppen P, Andersson G. Are psychological and pharmacologic interventions equally effective in the treatment of adult depressive disorders? A meta-analysis of comparative studies. J Clin Psychiatry. 2008 Nov;69(11):1675-85; quiz 1839-41. doi: 10.4088/jcp.v69n1102. Epub 2008 Aug 12.

    PubMed 18945396
  • Wolf NJ, Hopko DR. Psychosocial and pharmacological interventions for depressed adults in primary care: a critical review. Clin Psychol Rev. 2008 Jan;28(1):131-161. doi: 10.1016/j.cpr.2007.04.004. Epub 2007 Apr 29.

    PubMed 17555857
  • NICE Clinical Guideline 90 - Depression - The Treatment and Management of Depression in Adults. http://www.nice.org.uk/nicemedia/live/12329/45888/45888.pdf.

  • Cully JA, Paukert A, Falco J, Stanley M. Cognitive-behavioral therapy: Innovations for cardiopulmonary patients with depression and anxiety. Cognitive and Behavioral Practice. 2009; 16(4):394-407.

  • Kunik ME, Veazey C, Cully JA, Souchek J, Graham DP, Hopko D, Carter R, Sharafkhaneh A, Goepfert EJ, Wray N, Stanley MA. COPD education and cognitive behavioral therapy group treatment for clinically significant symptoms of depression and anxiety in COPD patients: a randomized controlled trial. Psychol Med. 2008 Mar;38(3):385-96. doi: 10.1017/S0033291707001687. Epub 2007 Oct 9.

    PubMed 17922939
  • National Institute of Mental Health. Statistics Web Site. http://www.nimh.nih.gov/statistics/index.shtml. Accessed June 03, 2013.

  • Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.

    PubMed 12435261
  • Kunik ME, Braun U, Stanley MA, Wristers K, Molinari V, Stoebner D, Orengo CA. One session cognitive behavioural therapy for elderly patients with chronic obstructive pulmonary disease. Psychol Med. 2001 May;31(4):717-23. doi: 10.1017/s0033291701003890.

    PubMed 11352373

Questions about this trial

What is this clinical trial studying?

A study testing Pre-Post Feasibility in people with Chronic Illness and Chronic Pain, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in Depressive Symptoms as Measured by the PHQ-8 (time frame: Intervention Study Period (Six Weeks/ Six Modules)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845102, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in