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

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

• Depression Symptoms [Срок оценки: 10 years]
• Anxiety Symptoms [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Depression Severity [Срок оценки: 10 years]
• Anxiety Severity [Срок оценки: 10 years]
• Anxiety Severity [Срок оценки: 10 years]
• Anxiety Severity [Срок оценки: 10 years]