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The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Registry

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ClinicalTrials.gov Identifier: NCT02443636
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
Nova Scotia Health Authority
IWK Health Centre
Nova Scotia Health Research Foundation
Dalhousie University
Information provided by (Responsible Party):
Rudolf Uher, Nova Scotia Health Authority

Brief Summary:

While effective interventions for depression exist, their success rates are unsatisfactory and their provision is haphazard. The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of outcomes for youths, adults and seniors with depression across the Maritimes. The investigators will establish an integrated system of assessment, treatment, research and education related to depression with the active involvement of those with lived experience. The establishment of a patient registry is a key step that will facilitate evaluation and reform of current services, integration of patient choice and community resources into treatment programs, monitoring long-term outcomes, and development of more effective treatment approaches through research. The registry will facilitate research that will include validation of new diagnostic and outcome measurement tools, low-cost clinical trials and collaborative projects with national and international partners. Educational programs will involve training the next generation of researchers, those with lived experience, clinicians, and health system managers in critical appraisal and will facilitate their involvement in research. The registry, the proposed systematic measurement of outcomes and the broad dissemination of information and skills will improve the quality of research and of care as well as the experience of patients and their families.

The need for a registry: It is increasingly recognized that major advances in the treatment of mental disorders will require large scale clinical research. Recently demonstrated ways of completing large-scale research with finite resources include the routine use of electronic health records (EHR), data linkage and randomized registry trial. Use of EHR is the most efficient way of rapidly obtaining large amounts of information. However, EHR cannot completely exclude confounding by indication and other unmeasured variables. Therefore, tests of treatment effects require experimental designs that cannot be replaced by routine health records data. The gold standard for testing the effects of treatment in an unbiased way is the randomized controlled trial (RCT), where measured and unmeasured confounders are balanced through the randomization process and any remaining confounding is due to chance alone. RCTs are valued as the highest level of evidence, but are costly and take significant time to be completed, partly because of the need to screen a large group of individuals to identify eligible participants.

The most efficient unbiased test of interventions, new treatment modalities and novel ways of treatment delivery is a method that combines EHR use with the randomized controlled trial (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a registry of individuals with available information to identify a large number of individuals suitable for an RCT. The RRT approach is efficient especially if the same information (e.g. diagnosis and treatment history) is used repeatedly for different purposes. The same information can be used for clinical purposes, service improvement and multiple research projects. RRT will allow obtaining answers about the efficacy of new treatments and management strategies significantly faster and at a much lower cost than traditional RCTs. Therefore, the investigators propose to establish a registry that has the capacity to conduct RRTs. The proposed registry will be integrated with similar efforts across Canada. Jointly, this collaborative network of registries will facilitate fast and economical testing of new treatments, which is urgently needed to advance the therapeutic options for people with depression and related conditions.


Condition or disease
Depression Post Traumatic Stress Disorder Bipolar Disorder Mood Disorder Suicide

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Canadian Depression Research and Intervention Network (CDRIN) Maritimes Registry: Reliable Assessment to Enable Research and Improve Clinical Care
Study Start Date : May 2015
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Status Assessment: General Functioning Youth [ Time Frame: 10 years ]
    Current level of functioning in children and youth with the widely used and validated Columbia Impairment Scale (CIS), parent and youth report. CIS is a 13-item questionnaire that provides a global measure of impairment with scored ranging from 0 to 52. Higher scores indicate a greater level of impairment. A score of 15 or higher is considered clinically significantly impaired.

  2. Status Assessment: Role and Social Functioning in Adults [ Time Frame: 10 years ]
    In adults, the investigators will assess current social functioning in adults with the widely used and validated clinician-rated 2-item Role and Social Functioning Scales (RSFS)

  3. Status Assessment: Work and Social Functioning [ Time Frame: 10 years ]
    In adults, the investigators will assess current work and social functioning with the self-report 5-item Work and the Social Adjustment Scales (WSAS).

  4. Status Assessment: Work Productivity [ Time Frame: 10 years ]
    In adults, the investigators will assess current work productivity with the the self-report 11-item Lam Employment Absence and Productivity Scale (LEAPS).


Secondary Outcome Measures :
  1. Depression Symptoms [ Time Frame: 10 years ]
    Depression symptom severity will be measured with the CDRS-R.

  2. Anxiety Symptoms [ Time Frame: 10 years ]
    The self- and parent-rated versions of the SCARED will be used to measure anxiety symptoms.

  3. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the MADRS.

  4. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the self-report QUIDS-SR.

  5. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the HAM.

  6. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the QIDS-C.

  7. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the BDI.

  8. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the PROMIS Depression scale.

  9. Depression Severity [ Time Frame: 10 years ]
    In adults, the current severity of depression symptoms will be measured with the CUDOS.

  10. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the BAI.

  11. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the PSWQ.

  12. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the SPIN.

  13. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the IES.

  14. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the CUXOS.

  15. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the CBAS.

  16. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the PROMIS anxiety scale.

  17. Anxiety Severity [ Time Frame: 10 years ]
    Anxiety in adults will be optionally measured with the HADS.

  18. Manic Symptoms [ Time Frame: 10 years ]
    Manic symptoms will be optionally measured with the YMRS.

  19. Manic Symptoms [ Time Frame: 10 years ]
    Manic symptoms will be optionally measured with the ASMS.

  20. Psychotic Symptoms [ Time Frame: 10 years ]
    Psychotic symptoms will be optionally measured with the PANSS.

  21. Suicidal Ideation and Behavior [ Time Frame: 10 years ]
    Severity of suicidal ideation and behaviour in children and adults will be measured with the CSSRS.

  22. Positive mood-related functioning [ Time Frame: 10 years ]
    New Measure: Engagement with Life Scale - self report (ELS-SR) is a self-report questionnaire developed based on qualitative material including interviews with individuals at different stages of recovery from depression and clinicians treating depression. It captures domains of functioning identified as related to mood and relevant to the quality of remission from depression. These domains include: enthusiasm, happiness, socializing, creativity, motivation, energy, interest, pleasure, decision-making, sense of purpose, self-confidence, resilience and hope.

  23. Positive mood-related functioning [ Time Frame: 10 years ]

    Engagement with Life Scale - clinician rated (ELS-C). This is a 16-item clinician-rated scale covering the same domains as the self-report version. It is administered as a semi-structured interview with obligatory and optional questions and then rated according to provided anchor points.

    Engagement with Life Scale - clinician rated (ELS-C). This is a 16-item clinician-rated scale covering the same domains as the self-report version. It is administered as a semi-structured interview with obligatory and optional questions and then rated according to provided anchor points.


  24. Acceptability of and preferences for pharmacological and psychological treatments [ Time Frame: 10 years ]
    New Measure: Treatment acceptability and preferences questionnaire (TAP-Q). Antidepressant medication and structured psychological therapy (such as cognitive behavioural therapy, CBT) are comparably effective for treating depression and related conditions. Many individuals have strong preferences for either pharmacological or psychological treatment, but there is no established way for measuring such preferences. Pre-existing attitudes are likely to influence outcomes of treatment trials comparing psychological and pharmacological treatments. Therefore, the investigators have designed a measure that starts by providing brief descriptions of typical first-line pharmacological and psychological treatment, then asks the individual about the acceptability of each treatment, about any barriers to acceptability, whether there is a preference for one treatment modality over the other and whether the participant would be willing to receive one or the other treatment by chance (randomly).

  25. Patient-centred outcomes [ Time Frame: 10 years ]
    New measure: While the clinician may be most concerned with the reduction of symptoms or achieving remission, each individual with depression may have her/his own goals and expectations from treatment: e.g. for one person a good outcome may be returning to a busy career, while for others it may be the ability to read a novel or enjoy time with grand children. A patient-centred outcome (PCO) recommended by individuals with lived experience of depression aims to measure achievement of such personalized treatment goals. PCO will be personalized in content (individual's most valued treatment goal) and standardized in scale (0-100% goal achievement). PCO will be developed collaboratively with each patient in a goal-setting session where the patient will name her/his most valued outcome and with the help of an interviewer will create specific anchors for what conditions should be fulfilled for the personally valued outcome to be 25%, 50%, 75% and 100% achieved.

  26. Side-effects of medication [ Time Frame: 10 years ]
    Unintended adverse reactions to medication are often a concern expressed by people living with mental illness. Therefore, the investigators will offer measurement of adverse reactions to medication ('side-effects') with several self-report scales including the Toronto Side Effects Scale (TSES)

  27. Side-effects of medication [ Time Frame: 10 years ]
    Unintended adverse reactions to medication are often a concern expressed by people living with mental illness. Therefore, the investigators will offer measurement of adverse reactions to medication ('side-effects') with several self-report scales including the Antidepressant Side-Effect Checklist (ASEC).

  28. Side-effects of medication [ Time Frame: 10 years ]
    Unintended adverse reactions to medication are often a concern expressed by people living with mental illness. Therefore, the investigators will offer measurement of adverse reactions to medication ('side-effects') with several self-report scales including the Sex Effects Scale (SexFX).

  29. Physical health [ Time Frame: 10 years ]
    In addition, the database will allow recording routine health indicators including body weight, height, waist circumference, blood pressure, C-reactive protein (a measure of systemic inflammation and cardiovascular risk), triglycerides, cholesterol, glucose, insulin, and glycated haemoglobin (measures of glucose metabolism). These indicators will allow evaluating effects of medication on body weight, metabolic status and cardiovascular risk.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population is english and french speaking males and females seeking or receiving help for mental health related problems in the Maritime provinces of Canada. Participants must have the capacity to provide informed consent or have an appropriate substitute decision maker that can provide consent on their behalf. Whilst the recruitment will be targeted to include individuals suffering with depression and other types of mental illness, no specific diagnosis is required for participation in the registry.
Criteria

Inclusion Criteria:

  • male or female
  • seeking or receiving help for mental health related problems in the maritime provinces of Canada
  • able to provide informed consent or have an appropriate substitute decision maker that can provide consent on their behalf.
  • English or French speaking

Exclusion Criteria:

  • There are no exclusion criteria related to age, sex, or ethnicity.
  • Whilst the recruitment will be targeted to include individuals suffering with depression and other types of mental illness, no specific diagnosis is required for participation in the registry.
  • unable to provide informed consent or does not have an appropriate substitute decision maker that can provide consent on their behalf
  • does not speak English or French

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): NCT02443636


Contacts
Contact: Erin (Beth) E McDougall, MSc 1-902-473-5313 beth.mcdougall@cdha.nshealth.ca

Locations
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Erin E McDougall, MSc    902-473-5313    beth.mcdougall@nshealth.ca   
Contact: Rudolf Uher, MD, PhD    902-473-7209    uher@dal.ca   
Sponsors and Collaborators
Rudolf Uher
Nova Scotia Health Authority
IWK Health Centre
Nova Scotia Health Research Foundation
Dalhousie University
Investigators
Principal Investigator: Rudolf Uher, MD, PhD Nova Scotia Health Authority
Principal Investigator: David J Pilon, PhD Nova Scotia Health Authority

Responsible Party: Rudolf Uher, Staff Psychiatrist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02443636     History of Changes
Other Study ID Numbers: 100270
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Keywords provided by Rudolf Uher, Nova Scotia Health Authority:
Depression
Mental Health
Registry
Reliability
Post Traumatic Stress Disorder
Bipolar Disorder
Mood disorder
Suicide

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Stress Disorders, Traumatic
Bipolar Disorder
Stress Disorders, Post-Traumatic
Suicide
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders
Bipolar and Related Disorders
Self-Injurious Behavior