Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02443636 |
| Other study ID # |
100270 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Nova Scotia Health Authority |
| Contact |
Erin (Beth) E McDougall, MSc |
| Phone |
1-902-473-5313 |
| Email |
beth.mcdougall[@]cdha.nshealth.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Registry The CDRIN Maritimes registry will provide an integrated platform for clinical
research and service evaluation. Participation in the registry will be offered to individuals
seeking help for mental disorders across primary, secondary and tertiary care settings in
Nova Scotia. In the spirit of participatory research, all participants in the registry will
become members of the registry and will be kept informed of registry development, as well as
educational and training opportunities. Those who have consented to be contacted regarding
future research opportunities will be invited to actively participate in research.
Number of participants The number of participants in the registry is not set in advance and
will depend on funding and needs of service development and research studies that will use
the registry. The registry will be scalable and the investigators expect to enrol between
1000 and 30,000 participants. For the additional reliability study, numbers of participant
have been determined based on a power calculation. A power calculation suggests that between
313 and 400 individuals assessed twice are required to establish the reliability of
diagnostic instruments with an acceptably small measurement error (confidence interval for
reliability coefficient alpha of 0.15 or smaller for disorders present in 10% of participants
or more). Therefore, the investigators propose to recruit 400 individuals for the reliability
study.
Inclusion and exclusion criteria The registry will be broadly inclusive with minimal
exclusion criteria. Any individual who is seeking or receiving help for mental health related
problems in Nova Scotia is eligible to become a member of the registry. Residents of Nova
Scotia will be eligible to enter the Registry if they understand English or French and have a
capacity to provide informed consent or if an appropriate substitute decision maker provides
consent on their behalf. 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. Recruitment is diagnosis-independent as the goal of the registry is to create an
inclusive database of individuals seeking mental health care in the Maritimes. As such, no
specific formal diagnosis is necessary. Many individuals will present at various primary,
secondary, and tertiary health care settings who will not meet full diagnostic criteria for a
mental health condition, but could still be sub threshold and meet diagnostic criteria at a
later time. It is important to include these individuals in the registry to facilitate the
clinical care of those seeking mental health care and also to facilitate research on various
subsets of individuals seeking mental health care, with and without formal mental health
diagnoses. Furthermore, restricting participation to people who only fulfill diagnostic
criteria would not allow for testing of the reliability of the diagnosis or the boundaries
between disorders and normality. Recruitment will be targeted toward individuals suffering
from a potential diagnosis of Depression as it is one of the most common and burdensome
mental health conditions in Canada. Participants will not be excluded from the registry if
they are found to not meet diagnostic criteria following diagnostic interviews.
Participant enrollment Potential participants will be approached at the point of
registration, in waiting rooms and during clinical consultations in primary, secondary and
tertiary care services that are likely to serve people suffering from depression and other
types of mental illness. A clinician or researcher will offer participation in the registry.
After explanation of the registry purpose and the need for reliability studies, participants
will provide written informed consent for their information to be kept in a registry and used
for research on the causation, classification and treatment of depression and other mental
disorders.
The participants will also be given the option to participate in instrument reliability
studies that may include repeated completion of the same instruments.
Assessments The registry will include a minimal set of core assessments (Tables 1 and 2) and
a broader palette of optional instruments (Tables 3 and 4) for screening, diagnosis and
current state (symptom profile, severity and functioning) assessment for youth (Table 1 and
3) and adult (Tables 2 and 4) participants. The selection of assessment instruments beyond
the minimal set will be determined in conjunction with participant, clinician and
investigator preferences. It is not expected that any participant would complete all optional
measures at any given time. Selection of instruments will take into account burden to
participants, so that no single assessment takes more than 3 hours. Tables 1 and 2 list the
minimal sets of instruments for youth and adult participants. Table 3 shows the broad palette
of optional instruments for youth and table 4 shows the full palette of assessment
instruments for adults. Screening and status assessment instruments will be administered
repeatedly (typically once every 3-6 months, but more often if needed to assess an effect of
recently initiated treatment or change in care delivery). Diagnostic instruments will
typically be administered once (twice for participants in a reliability study), but may be
repeated in after 1 to 5 years to assess changes in psychopathology profile and diagnoses.
Screening instruments Strengths and Difficulties Questionnaire (SDQ) will be the core
screening instrument for youth participants up to age 16. SDQ is a 25-item measure of
psychopathology for children and adolescents with parent-report and self-report versions
validated for ages 3-16 and 11-16 respectively. Simple and accessible language makes SDQ easy
to complete. Balance of positive and negative items makes this measure highly acceptable. The
total difficulties scale / emotional subscale is a highly sensitive screener for depression
and anxiety disorders in youth. The questionnaire takes only 5 minutes to complete and
detects depression and other disorders with an accuracy equal to or higher than longer
instruments. An established cut-off value of 14 on the total difficulties scale of SDQ will
be used to select participants who are likely to suffer from depression or related disorders.
Patient Health Questionnaire (PHQ-9) will be the core screening instrument for adults and
older adolescents (from age 17). PHQ-9 is a 9-item self-report questionnaire that has been
extensively validated for use with adults and, more recently, adolescents. PHQ-9 is highly
sensitive in screening for depression, with a score of 10 or higher suggestive of diagnosis.
Thanks to its brevity and straightforward response format, PHQ-9 is easy and quick to
complete, has been found to be acceptable and is widely used in primary and secondary care
practice.
Mood and Feelings Questionnaire (MFQ) will be an alternative screening measure for older
children and adolescents that is more directly focussed on depression. MFQ has two versions:
a long 33-item version and a short 13-item version. The investigators will use the short MFQ,
which has been validated for 7- to 18-year old participants and has been found to be
acceptable with a cut-off of 11 or more being highly sensitive in detecting a diagnosis of
major depressive disorder.
Screen for Child Anxiety Related Emotional Disorders (SCARED) and the Generalized Anxiety
Disorder 7-item scale (GAD-7) will be used as optional screening measures for services and
investigators interested in detecting anxiety disorders in addition to depression. SCARED
self-report and parent-report versions have been validated for children and adolescents aged
8-18, with a high-sensitivity threshold of 20 for detecting anxiety disorders. The
self-report and parent-report versions have been found to be psychometrically equivalent.
GAD-7 has been validated as a highly sensitive screen for generalized anxiety disorder in
adults. GAD-7 is moderately specific for generalized anxiety and detects a range of anxiety
disorders.
Everyday Feelings Questionnaire (EFQ) will be optionally used to screen for depression and
anxiety disorders among parents of child and adolescent participants. EFQ is a brief 10-item
measure of current depressive and anxiety symptoms with a balance of positive and negative
items making it highly acceptable, non- stigmatizing and suitable for a brief assessment of
emotional wellbeing in the parents of children and adolescents presenting to health services.
Availability of a spouse-report version facilitates obtaining information on both parents
when only one parent is available for direct assessment. EFQ has excellent psychometric
properties and strong convergent validity with established measures of depression and
anxiety.
Diagnostic instruments Kiddie Schedule for Affective Disorders and Schizophrenia - Present
and Lifetime version, adapted for the Diagnostic and Statistical Manual of Mental Disorders
(DSM)-5th Edition (K-SADS -5). K-SADS -5 is a semi-structured diagnostic interview to
establish current and lifetime diagnoses of mental disorders in children and adolescents
based on interviews with parent and with the young person. Previous versions of K-SADS have
been validated for children and adolescents aged 7-18 and have been found to have high
inter-rater reliability. K-SADS has recently been adapted to DSM-5 by Dr Joan Kaufman and
colleagues at Yale University (as K-SADS-5) and is awaiting a test of reliability. Based on
the K-SADS-5, the investigators will derive best estimate DSM-5 diagnoses established in
consensus meetings involving experienced psychiatrists blind to the diagnoses of parents.
Information provided by parents will be submitted for use in these meetings after being
checked to be free of any indication of parental diagnosis. Our team has received training in
using K-SADS by the team of John Nurnberger and will be receiving additional training on the
DSM-5 adaptation with Dr Joan Kaufmann in September 2014.
Structured Clinical Interview for DSM-5 (SCID-5) is a semi-structured diagnostic interview
for adults designed to be administered by a clinically trained interviewer. While earlier
versions of SCID have been shown to be highly acceptable and reliable, the recently developed
SCID-5 is awaiting its test of reliability. SCID-5 provides exact wording of questions to ask
for specific diagnostic symptoms but allows additional probing to establish the symptom
presence and timing with adequate accuracy and make a judgment about its clinical
significance. SCID-5 provides algorithmic rules that guide the interviewer through DSM-5
diagnoses and allows skipping questions that will not make a difference to a diagnostic
conclusion, given the information already provided. In October 2013 Dr. Michael First
(Columbia University) trained the team of investigators at Dalhousie in using SCID-5. Based
on our preliminary experience, a SCID-5 interview can last between 45 minutes and 3 hours,
depending on the complexity of psychopathology, efficiency of the interviewer and
communication skills of the interviewee. The interviewers will be clinically trained nurses,
social workers, occupational therapists, psychologists or psychiatrists. They will initially
receive a three-day training from Dr. First, the author of SCID-5 and a collaborator in this
project. Following this, the investigators will conduct once monthly meetings to review
recorded interviews, discuss intervening issues and maintain the quality of interview
administration. The investigators expect most of the interviews (70%) to be carried out by
research coordinators (nurses/social workers/occupational therapists) and a smaller
proportion (30%) to be carried out by the investigators and clinicians (psychiatrists and
clinical psychologists). The investigators will record the qualifications and experience
level of each interviewer.
Status assessment: symptom severity and functioning Current severity of depressive, anxiety
and psychotic symptoms will be assessed with established and validated self-report and
clinician-rated instruments. In children and adolescents, the primary measure of depression
symptom severity will be the broadly used and extensively validated 16-item clinician-rated
Children's Depression Rating Scale-Revised (CDRS-R). In addition, the self- and parent-rated
versions of the widely used and validated 41-item Screen for Child Anxiety Disorders (SCARED)
will be used to measure anxiety symptoms in children and adolescents.
In adults, the current severity of depression symptoms will be measured primarily with the
10-item clinician-rated Montgomery and Åsberg Depression Rating Scale (MADRS), an internally
consistent scale that is highly sensitive to therapeutic change, and the self-report Quick
Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR), a widely used and extensively
validated measure of depressive symptoms that closely matches DSM diagnostic criteria for
depression. Optional and alternative measures of depressive symptom severity in adults will
include the clinician-rated Hamilton Rating Scale for Depression (HAM-D) and Quick Inventory
of Depressive Symptomatology - Clinician Rated (QIDS-C) and the self-report Beck Depression
Inventory (BDI),60,54 , the PROMIS depression scale (http://www.nihpromis.org/) and the
Clinically Useful Depression Outcome Scale (CUDOS). Anxiety in adults will be optionally
measured with the self-report Beck Anxiety Inventory (BAI), Penn State Worry Questionnaire
(PSWQ), Social Phobia Inventory (SPIN), Impact of Event Scale (IES), Clinically Useful
Anxiety Outcome Scale (CUXOS) and Cognitive Behavioural Avoidance Scale (CBAS), the PROMIS
anxiety scale (http://www.nihpromis.org/) and the Hospital Anxiety and Depression Scale
(HADS).
Manic symptoms will be optionally measured with the clinician-rated Young Mania Rating Scale
(YMRS) and the self-report Altman Self-rated Mania Scale (ASMS). Psychotic symptoms will be
optionally measured with the clinician-rated Positive and Negative Symptom Scale (PANSS).
Severity of suicidal ideation and behaviour in children and adults will be measured with the
paediatric and adult versions of the Columbia Suicide Severity Rating Scale (CSSRS).
Status assessment: functioning The investigators will assess 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. In adults, the
investigators will assess current level of general, role- and social functioning in adults
with the widely used and validated clinician-rated 2-item Role and Social Functioning Scales
(RSFS), the self-report 5-item Work and the Social Adjustment Scales (WSAS) and the
self-report 11-item Lam Employment Absence and Productivity Scale (LEAPS).
New Measures New instruments have been developed to measure two domains of interest for which
no adequate established measures were identified: positive mood-related functioning and
acceptability of and preferences for pharmacological and psychological treatments.
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. For example, individuals clinically recovered from depression often
noted that before getting depressed they had been keen to try new things and associated this
with being well, therefore, the measure includes items related to wanting to try new things
to do and starting new activities. At present, this measure is at a developmental stage of a
50-item bank. The investigators propose to collect responses from 400 participants to obtain
psychometric data that will allow shortening the measure to optimize efficiency and avoid
redundancy.
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 (enthusiasm, happiness, socializing,
creativity, motivation, energy, interest, pleasure, decision-making, sense of purpose,
self-confidence, resilience and hope). It is administered as a semi-structured interview with
obligatory and optional questions and then rated according to provided anchor points. The
added value of the clinician-rated version is a degree of objectivity added by the
clinician's judgement. Like the self-report version, this scale will undergo psychometric
analysis and is likely to be refined and shortened based on the results.
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). The investigators have obtained pilot data from 60 participants, who have found
the measure clear and easy to complete. The investigators propose using this measure with 400
individuals with depression to carry out psychometric analysis and establish the rates of
treatment preferences in Nova Scotia.
Patient-centered outcomes 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.
Physical health and side-effects of medication 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), the Antidepressant
Side-Effect Checklist (ASEC) and the Sex Effects Scale (SexFX). The three scales complement
each other: TSES has the broadest range of symptoms, ASEC adds additional
antidepressant-specific side effects and assesses the probability of association with an
antidepressant, and SexFX assesses sexual side effects that are common but not well covered
by the other scales. 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.
Data linkage The registry will have the capacity to be linked with public health and
population databases using health card numbers. For participants who provide consent for data
linkage, this will allow accessing additional information on health service utilization,
prescriptions and diagnoses with no additional assessment burden. In addition, this will
allow obtaining prospective information on longevity and causes of death and information
about participants who are lost to follow-up.
Release of research data for clinical use To fulfill the mission of CDRIN to use research
data for improvement of clinical care and following on suggestions from people with lived
experience of depression, the registry participants will be able to choose that
health-related information kept on them in the Registry be sent to their clinicians. This may
provide additional information, save time, spare participants answering the same questions
repeatedly, streamline clinical care and enhance evidence-based practice. Information will
only be passed to clinicians on explicit (verbal or written) request of the participant. The
information passed on to clinicians will take the form of a single sheet concisely
summarizing the diagnostic and outcome information on the participant obtained so far as well
as tips about possible treatments and community resources. Mental-health communication
specialists (e.g. Healing Tree Communications) will review the form passed on to clinicians
to maximise its usefulness and minimize the risk of passing on unhelpful or confusing
information. External communication specialists will only provide guidance on the design and
format of the generic feedback template. These communications specialists will not access any
information on individual participants (identified or de-identified).
Potential benefits Unlike most ongoing research projects, the CDRIN Maritimes Registry will
become a resource for clinical care and the participants are likely to personally benefit
from their participation in the project. Participants will be able to request that the
information collected about them in the Registry be sent to clinicians they are going to see.
Participants will also be sent information about existing community resources, such as peer
support and vocational services.
The study involving reliability of assessment instruments will not directly benefit the
participants, but will ensure that instruments used to assess the diagnoses and severity of
depression and related mental disorders are reliable and that different psychiatrists and
other clinicians agree when making the diagnosis or measuring the severity of a disorder.
More accurate measurement will improve the fit between individual's problems and prescribed
treatment and will facilitate evidence-based practice. Training of health professionals in
the use of reliable diagnostic and assessment instruments is known to improve the quality of
clinical care. Routine systematic collection of outcome information will also facilitate the
evaluation of specific treatment procedures, service changes and improvement initiatives.
This will improve the quality of care for depression and other mental disorders in the medium
to long term.
Potential harms All proposed procedures are safe and carry very low-risk. The potential harms
include the burden of repeated interviews, upsetting content of diagnostic interviews and
inadvertent breaches of confidentiality.
Burden of repeated interviews. The diagnostic interviews can be time-consuming, lasting
typically 90-120 minutes. Repeating the same interview twice within a short time can be
perceived as boring and it may put a strain on the participants' time resources. The
investigators take the participants' time limitations seriously and the investigators take
the following measures to limit the negative impact of interview burden. The investigators
inform each participant in advance about the likely duration of interviews and emphasise that
they are free to decide to participate or not in the interviews and that opting out of the
repeated interview does not change their participation in the Registry. The investigators
minimize the time required for interviews by efficient preparation and interviewer training.
The investigators reimburse participants for their travel expenses and time spent with the
repeated interviews.
Upsetting interviews. The diagnostic interviews and assessment instruments inevitably ask
questions that can be upsetting for some participants. These include questions about the
symptoms experienced in the past, suicide attempts, hospital admissions and traumatic
experiences. Evidence shows that asking such sensitive questions is not harmful and that
participants prefer to discuss these personally important issues with sensitive professionals
rather than avoiding them. The investigators will minimize the upsets and provide a
containing environment with the following measures. All staff conducting the interviews will
have clinical experience and be able to contain upsets in a sensitive and responsible way. At
the beginning of each interview, it will be emphasised that participants can refuse to answer
specific questions or can chose to discontinue the interview if they find it too upsetting.
An on-call system involving the investigators will be in place to bring in a psychiatrist if
a participant is judged to be too upset or if risk to self or others is judged to be acutely
increased. Most investigators are licensed psychiatrists or clinical psychologists, can
attend at short notice, provide crisis intervention and arrange a referral if appropriate.
Breaches in confidentiality. In the course of this study participants will provide
information that is highly sensitive since it concerns private experiences, information about
mental health and personal information including contact details. The investigators will
maintain the highest standards of confidentiality and minimize the potential harms from any
breaches of confidentiality in the following ways. First, information that directly allows
identification of subjects [names, addresses and similar] will be encoded using alphanumeric
codes [the investigators will not use initials]. Collected information will be kept in a
secured relational database in anonymized form with only the alphanumeric code identifying
each participant. Personal information, contact details and their relationship to the
alphanumeric code will be kept separate from the remainder of the data and secured with an
even higher degree of security [kept in a password-protected file on a computer only
accessible to the principal investigators and the study coordinators]. Even the anonymized
data will only be accessible to study investigators and authorized staff of Dalhousie
University, Capital District Health Authority and the Izaac Walton Killam (IWK) Health
Centre, who are directly linked with the study and are familiar with principles of
confidentiality and personal data protection. Information necessary for collaborative studies
will only be made available to known researchers from academic institutions on signing a
transfer agreement that includes binding statements on data confidentiality. All
investigators will be required to keep study related data in encrypted/password-protected
files on password-protected computers only, and take all precautions to prevent access by
unauthorized individuals. No personally identifiable information will be made publicly
available without separate REB approval and the participant's consent.
Balance of benefits and harms With the above outlined measures to minimize foreseeable
potential harms, the investigators believe that the minimal risk of harm to participants will
be outweighed by the expected direct benefits to participants, benefits to society and the
advancement of knowledge stemming from the proposed research.
Future directions The investigators envisage that the Maritimes Depression Registry will
become a long-term resource that will facilitate clinical research efforts and pioneer the
iterative use of research information for improvement of clinical care and services. The
assessment instruments with demonstrated reliability will become part of assessment for both
research and clinical purposes. Specific instruments for assessing the positive aspects of
mood and functioning and treatment preferences will fill in gaps in our assessment
instruments. The registry will become a platform for large-scale low-cost clinical trials.
The registry infrastructure will serve as a platform to develop and assess components to be
incorporated in EHR systems that are expected to be implemented between 2019 and 2021.
