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

NCT02443636 | Recruiting

• 1 other identifier: 100270
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Post Traumatic Stress Disorder; Bipolar Disorder; Mood Disorder; Suicide

Keywords

Depression; Mental Health; Registry; Reliability; Post Traumatic Stress Disorder; Bipolar Disorder; Mood disorder; Suicide

Outcome Measures

Primary Outcomes (4)

• Status Assessment: General Functioning Youth

  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.

  10 years

• Status Assessment: Role and Social Functioning in Adults

  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)

  10 years

• Status Assessment: Work and Social Functioning

  In adults, the investigators will assess current work and social functioning with the self-report 5-item Work and the Social Adjustment Scales (WSAS).

  10 years

• Status Assessment: Work Productivity

  In adults, the investigators will assess current work productivity with the the self-report 11-item Lam Employment Absence and Productivity Scale (LEAPS).

  10 years

Secondary Outcomes (29)

• Depression Symptoms

  10 years

• Anxiety Symptoms

  10 years

• Depression Severity

  10 years

• Depression Severity

  10 years

• Depression Severity

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• IWK Health Centre: collaborator
• Nova Scotia Health Research Foundation: collaborator
• Dalhousie University: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Bipolar Disorder; Mood Disorders; Suicide; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Bipolar and Related Disorders; Self-Injurious Behavior; Personal Satisfaction

Study Officials

• Rudolf Uher, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• David J Pilon, PhD

  Nova Scotia Health Authority

  STUDY DIRECTOR

Central Study Contacts

Jessica Toombs, MSc

CONTACT

1-902-473-5313; jessica.toombs@nshealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)