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Feedback to Improve Depression Outcomes (PCMBC)

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ClinicalTrials.gov Identifier: NCT03162211
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Rudolf Uher, Nova Scotia Health Authority

Brief Summary:
Depression is a leading cause of burden in Canada and globally. Although more people now seek and receive treatment for depression, there are still many who do not respond well to treatments. New and low-cost options are needed to improve the lives of people with depression. Research suggests that asking patients to complete questionnaires and sending feedback to their clinicians may improve depressive symptoms. Research also shows that encouraging individuals with depression to take part in shaping their own care can be beneficial. To date, no research has examined a combination of these two approaches. This project aims to investigate the benefits of providing personalized feedback to patients and clinicians in order to improve the care and outcomes for people with depression in Canada. To answer this research question, adults who are diagnosed with depression will be placed in one of two groups: 1. The patient and clinician will receive feedback to help guide further care based on the patient's responses to questionnaires 2. The patient and clinician will not receive feedback. The feedback form has been developed with input from clinicians, researchers and people with lived experience of depression, and follows new Canadian treatment guidelines. Information including depressive symptoms, quality of life, personal goals for recovery, and healthcare costs will be collected for a year or longer using an online data collection platform. The research team includes clinician-scientists, healthcare managers, educators, primary care physician and people with lived experience of depression. This project has the potential to deliver significant health benefits for individuals with depression, lessen the population burden of depression and improve the health care system by optimizing care delivery and improving quality of life at low cost.

Condition or disease Intervention/treatment Phase
Depression Other: Feedback Report Not Applicable

Detailed Description:

Goal: To improve the outcomes of depression by applying measurement based care that is person-centered and provides individualised feedback to providers and patients within a collaborative mental health care framework.

Background: Depression is a leading cause of disease burden in Canada and globally. Although help-seeking and treatment rates have increased, the outcomes of depression remain unsatisfactory with high rates of inadequate treatment response, chronicity and recurrence. Recent data suggest that measurement-based care with regular ratings of depression symptoms coupled with feedback of results to clinicians and patients may improve outcomes. There is also evidence for the benefits of person-centered approaches that empower individuals living with depression to take active part in shaping their care. Person-centered care that integrates measurement-based feedback is yet to be tested.

Aims: To test the benefits of person-centered measurement-based care in improving outcomes of depression in contemporary Canadian primary and collaborative health care context.

Approach: We will test the benefits of person-centered measurement-based feedback in a randomized registry trial. Adults aged 18 or older diagnosed with major depressive disorder or persistent depressive disorder will be allocated to have a regular measurement-based feedback sent to themselves and their clinicians or not in a 1:1 ratio. The feedback was designed with a council of individuals with depression following the principles of patient-centered and measurement-based care and the recommendations of the 2016 Canadian Network for Mood and Anxiety Treatment guidelines. An on-line registry platform will be used to collect self-report and clinician-rated depression severity, role functioning, quality of life and person-centered self-defined goals. The primary outcome will be meaningful change in treatment and depression severity measured with the self-reported Quick Inventory of Depressive Symptomatology at 1, 3, 6 and 12 months after study entry. Secondary measures will include remission of depression, core role and occupational functioning, quality of life, healthcare cost and self-defined treatment goals. A cost-effectiveness analysis will determine the cost of improved outcomes in terms of quality of life.

Core expertise: The applicants include clinician-scientists, healthcare managers, educators and people with lived experience of depression. The applicants have expertise in depression, primary and collaborative care, clinical trials, epidemiology, statistics, psychometrics and health economics. The registry and feedback forms were developed as part of the Canadian Depression Research and Intervention Network which promotes involvement of individuals with lived experience in research. The database and statistical analyses are supported by the Research Methods Unit.

Expected outcomes: This project will deliver an innovative platform for person-centered measurement-based care for depression through collaborative mental health care. We expect that person-centered measurement-based care will lead to significant health benefits by optimizing care delivery, reducing burden of depression and improving quality of life at low cost. The outcomes of this research will be disseminated through professional networks, patient support organizations, on-line media and education of health professionals.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Improving Outcomes of Depression Through Person-centered Measurement-based Care and Individualized Feedback
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feedback Arm
A registry platform including access to all self-report rating scales and the feedback mechanism will be made available to all patients. Patients in the experimental group will receive automated reminders (by text message, phone and/or email) to complete outcome measures each week. Feedback forms will be comprehensive and condensed to a one page report including graphical presentations of symptom course and text. Clinician feedback forms will include content on depression severity over time and recommendations for individualized treatment. Patient feedback forms will also incorporate depression severity over time as well as summary information on achievement towards personalized treatment goals. The intervention will last 6-months, with feedback forms being generated once per week for the first three month and then each month for a total of fifteen feedback time points. Patients in the feedback group will be encouraged to meet with their clinician each month to discuss the feedback.
Other: Feedback Report
There are two types of feedback forms: 1. Patient feedback forms and 2. Clinician feedback forms. Feedback form content has been developed in consultation with a board of clinicians, service providers, and patients living with depression. Feedback forms will be comprehensive and condensed to a one page report including graphical presentations of symptom course and text. Clinician feedback forms will include content on depression severity over time and recommendations for individualized treatment. Patient feedback forms will also incorporate depression severity over time as well as summary information on achievement towards personalized treatment goals.

No Intervention: No Feedback Arm
A registry platform including access to all self-report rating scales and the feedback mechanism will be made available to all patients. Patients in the control group will not receive regular reminders or be sent feedback reports on an automatic regular basis.



Primary Outcome Measures :
  1. Meaningful change in treatment [ Time Frame: Month 0-6 ]
    The first primary outcome will be a meaningful change in treatment as assessed by a clinical expert using CANMAT guidelines.

  2. Total score QIDS-SR [ Time Frame: Month 0-6 ]
    The second primary outcome will be the total score ranging from 0-27 on the 16-item QIDS-SR, a widely used and extensively validated self-report measure of depressive symptoms that aligns closely with DSM diagnostic criteria for depression.


Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Month 0-6 ]
    Secondary outcomes include the MADRS completed by a clinical researcher blind to allocation

  2. WSAS [ Time Frame: Month 0-6 ]
    Core role and occupational functioning as measured by the total score on the self-report 5-item Work and the Social Adjustment Scales (WSAS)

  3. LEAPS [ Time Frame: Month 0-6 ]
    Core role and occupational functioning as measured by the total score on the self-report 11-item Lam Employment Absence and Productivity Scale (LEAPS).

  4. EQ-5D [ Time Frame: Month 0-6 ]
    Health-related quality of life will be measured with the EQ-5D.32 The EQ-5D measures the extent to which an individual's health impacts quality of life and is recommended for Canadian economic evaluations.

  5. My Top Goal [ Time Frame: Month 0-6 ]
    Self-defined treatment goals will be measured by My Top Goal, personalized in content (individual's most valued treatment goal) and standardized in scale (0-100% goal achievement).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5)
  • depression being the primary current problem requiring clinical attention judged by an intake clinician
  • age 18 or more (no upper limit)
  • capacity to provide informed consent

Exclusion criteria:

  • lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, current alcohol or drug use disorder
  • pregnancy
  • acute suicide risk (Montgomery and Asberg Depression Rating Scales (MADRS) (suicide item≥4)
  • current psychotic symptoms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162211


Contacts
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Contact: Rudolf Uher, MD, PhD 1-902-473-7209 rudolf.uher@nshealth.ca
Contact: Jill Cumby, RN 1-902-473-1782 jill.cumbyl@nshealth.ca

Locations
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Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Jill Cumby, RN    902-473-7209    jill.cumby@nshealth.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Rudolf Uher, MD, PhD Nova Scotia Health Authority

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Responsible Party: Rudolf Uher, Dr., Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03162211     History of Changes
Other Study ID Numbers: 1022385
Catalyst 1160 ( Other Grant/Funding Number: Nova Scotia Health Research Foundation )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders