UTSW Depression Cohort: A Longitudinal Study of Depression
Condition: Depression; Other Diagnoses, Comorbidities, and Complications
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      This is a longitudinal observational study (via electronic records and biospecimens) designed
      to utilize health IT advances to collect information from patients undergoing routine care.
      This information will be stored in a database. Patients undergoing routine care from their
      providers will be invited to participate in the UTSW Depression Cohort. After obtaining
      informed consent, the CDRCC team will collect information from available sources and store it
      in a secure UT Southwestern network database protected by a security firewall. A schematic
      representation of this information processing is shown in the figure contained in section 3
      of the protocol. As part of the UTSW Depression Cohort, patients will allow banking of their
      specimens. Specimens which are banked may include blood or blood products, urine, tissue
      samples, saliva, stool samples or clinical waste products. The study will only enroll
      participants comfortable with providing specimens. As the goal of the UTSW Depression Cohort
      is to create a national database, CDRCC will engage with patients, providers, and researchers
      at local, regional, and national levels. A large number of medical providers are already
      screening patients for depression. Structured instruments like PHQ-2 or PHQ-9 are often used.
      Hence, the CDRCC will seek collaborations with local, regional and national partners so that
      information contained in their health IT initiatives can be included in the this database.
      Due to the clinical nature of information collected, the investigators anticipate marked
      heterogeneity in the variables and amount of data collected. Database architects will utilize
      big data (large volumes of information from diverse sources with variable degrees of quality
      and complexity) tools to structure the registry so that additional variables can be added, as
      needed. The CDRCC team will maintain a detailed codebook of variables collected in the
      database. All statistical analyses will be conducted only on de-identified data. Researchers
      may obtain access to this de-identified data by following procedures established by the
      CDRCC, which include obtaining IRB approval.
    

Detailed description: 
      This is a longitudinal observational study designed to utilize health IT advances to collect
      information from patients undergoing routine care. This information will be collected as part
      of routine care and stored in a database for research purposes. Patients undergoing routine
      care from their providers will be invited to participate in the UTSW Depression Cohort. After
      obtaining informed consent, the CDRCC team will collect information from sources outlined in
      background section of protocol and store it in a secure UT Southwestern network database
      protected by a security firewall. A schematic representation of this information processing
      is shown on page 7 of the protocol. The CDRCC team will also collect specimens which are
      obtained as part of standard of care and are beyond the amount needed for routine clinical
      care. For research-only purposes, CDRCC team will also collect blood, saliva, stool and urine
      specimens at regular intervals described in subsequent section with the consent of study
      participant.

      Clinics or health care facilities collaborating with CDRCC will approach their patients to
      participate in this cohort. Research staff from UTSW or staff at these clinics (or health
      care facilities) who have received training on how to obtain informed consent will then ask
      interested patients to sign the IRB-approved Informed Consent and HIPAA authorization
      documents. Initially, the Informed Consent and HIPAA authorization will be documented on
      paper, and these documents will be scanned and stored in the master log of the Cohort
      database in addition to securely storing the paper copy. In the future, patients will be
      asked to complete Informed Consent and HIPAA authorization documents using computers or
      handheld electronic devices (including signatures). Paper documents will be made available to
      those who prefer and request them. Staff from CDRCC will be available either in person, by
      email, or by phone to answer any questions that arise during the informed consent process
      that cannot be answered by clinic staff. If patients are under the age of 18, they will
      provide assent, and a parent or LAR will provide consent. The CDRCC will also develop
      materials in print and electronic format to publicize the UTSW Depression Cohort. Other
      patients or healthy individuals who are not involved with a CDRCC collaborator can also join
      the registry if they complete the informed consent process. The UTSW Depression Cohort will
      include comprehensive information collected as part of routine care by the patient's
      provider(s). During routine care at their medical providers' offices, patients may fill out
      screening questionnaires and self-rated behavioral health assessments, provide medical and
      psychiatric history, undergo laboratory tests, electrocardiogram (EKG), radiologic or other
      clinically relevant investigations and be given treatment recommendations. Some of the
      self-rated assessments completed as part of measurement based care may include Patient Health
      Questionnaire 2 (PHQ-2), Patient Health Questionnaire 9 (PHQ-9), Patient Adherence
      Questionnaire (PAQ), Frequency, Intensity, and Burden of Side Effects Rating (FIBSER),
      Generalized Anxiety Disorder 7 (GAD-7), Concise Associated Symptoms Tracking - Self-Report
      Scale (CAST-SR), Pain Frequency, Intensity, and Burden Scale (P-FIBS), Concise Health Risk
      Tracking Scale (CHRT), and Alcohol and Drug usage screen. The information in the Cohort
      database will be stored indefinitely unless a participant requests the principal investigator
      to remove his/her name and associated information.

      Research only assessments As part of the UTSW Depression Cohort, participants will undergo
      diagnostic assessment using MINI International Neuropsychiatric Interview, Version 7.0 for
      DSM-5 (MINI) and complete self-report research assessments for psychiatric symptoms and
      psychosocial functioning. These research only assessments will add 60-90 minutes to the visit
      duration.

      Specimen banking:

      As part of the UTSW Depression Cohort, patients will allow banking of their specimens. The
      study will only enroll participants comfortable with providing specimens. Of course, like
      with any other study procedure, those not comfortable with providing specimens will not be
      enrolled in this study. Specimens which are banked may include blood or blood products,
      urine, stool samples, tissue samples, saliva or clinical waste products. Clinical waste
      products include surgical waste tissue samples, placenta samples and biopsy samples. Once a
      sample is collected, all identifying information will be removed, and it will be given a
      unique code. The information linking this unique code to a patient's identifying information
      will be stored in the master log. Samples will be stored appropriately in the CDRCC freezers
      located in the north campus building of UT Southwestern. Samples will be overseen by CDRCC
      research personnel. A sample will be stored indefinitely until the sample runs out or it is
      destroyed.

      Blood and blood products- Blood will be obtained by venipuncture performed by personnel with
      phlebotomy training.

      Adult blood draws will not exceed the following:

      Patient weight Maximum Volume per 24 hour Maximum Volume per Month Kilograms Pounds
      Milliliters Milliliters 51-60 112-132 112-120 224-240 61-65 134-143 122-130 244-260 68-70
      145-154 132-140 264-280 71-75 156-185 142-150 284-300 76-80 167-176 152-160 304-360 81-85
      178-187 162-170 324-340 86-90 189-198 172-180 344-360 91-95 200-209 182-190 364-380 96-100
      211-220 192-200 384-400

      Pediatric blood draws will not exceed:

      Patient weight Maximum Volume per 24 hour Maximum Volume per Month Kilograms Pounds
      Milliliters Milliliters <0.9 <2 3 12 0.9-1.8 2-4 4.5 18 1.9-2.7 4-6 6 24 2.8-3.6 6-8 7.5 30
      3.7-4.5 8-10 10.5 42 4.6-6.8 10-15 15 60 6.9-9.1 16-20 30 120 9.2-11.4 21-25 30 120 11.5-13.6
      26-30 30 120 13.7-15.9 31-35 30 120 16.0-18.2 36-40 30 120 18.3-20.5 41-45 60 240 20.6-22.7
      46-50 60 240 22.8-25.0 51-55 60 240 25.1-27.3 56-60 60 240 27.4-29.5 61-65 75 300 29.6-31.8
      66-70 90 360 31.9-34.1 71-75 90 360 34.2-36.4 76-80 90 360 36.5-38.6 81-85 90 360 38.7-40.9
      86-90 90 360 41.0-43.2 91-95 90 360 43.3-45.5 96-100 90 360

      Blood may be obtained as a single blood draw, which may be a patient's only collection.
      Patients may be contacted to provide similar specimens at intervals around every 3-4 months
      for over 5-10 years (for a total of 40 blood draws). Collections will be restricted by the
      maximum safe volumes outlined above for both adult and pediatric participants. If being
      obtained in a clinical setting, clinical care specimens will take precedence over research
      specimens. If specimens are obtained during the course of clinical care, a safe volume will
      be determined in conjunction with treating physicians, but will not exceed the above table.

      Saliva- Saliva will be collected into the Oragene DNA and/or RNA self-collection kit and
      stored at room temperature until DNA isolation.

      Urine- Urine samples will be collected in sterile urinalysis cups and 10 mL aliquots will be
      frozen at -80°C in conical tubes.

      Stool- Stool samples will be collected once or possibly over time in conjunction with blood
      draws described above in sterile 50 ml conical tubes and will be frozen at -80°C.

      Clinical waste products- Samples obtained could include: a. surgical waste tissue samples; b.
      placenta samples; and c. biopsy samples. These samples will be obtained as a part of standard
      of care. Procedures involving these sample collections will be done by trained physicians and
      medical technicians only. The tissue that will be used for research is the tissue that would
      normally be discarded. After providing informed consent, study participants may allow study
      personnel to collect these clinical waste products from the clinical sites. The clinical
      waste product will then be transported to CDRCC on ice for storage. These samples will be
      de-identified, stored and used for future research. There will be no cost or compensation to
      the patients for donating this tissue to CDRCC.

      The intended use of these samples is to enable future research into the diagnostics,
      prognostics and biologic understanding of depression. The samples will be primarily used by
      investigators affiliated with UT Southwestern, but will also be released to public and
      private collaborators in a HIPAA compliant fashion (i.e., de-identified). Development of cell
      lines and DNA libraries may occur with these samples. Samples may be used by investigators
      not affiliated with UT Southwestern if they are collaborating with a UTSW investigator. Also,
      samples may be used by colleagues at other institutions who are conducting their own IRB
      -approved research. Furthermore, de-identified samples can be provided to collaborators in
      industry if appropriate technology transfer agreements are in place. Samples sent to
      investigators or private entities outside of UT Southwestern will have a charge associated
      with them based on sample cost and projected use of the samples. Any specimen or data can be
      released to collaborators (outlined above) as long as it is released in a HIPAA compliant
      fashion (i.e., de-identified).

      The investigators will obtain an IRB approval letter and maintain a current record of the
      Federal Wide Assurance (FWA) for an IRB at another medical center if data and specimens are
      sent from human cell banks at UT Southwestern to another medical center. If an investigator
      at another medical center receives data and specimens from our Cohort at UT Southwestern, the
      investigator will maintain documentation that (a) the recipient of samples from CDRCC
      acknowledges that the conditions for use of the research material are governed by the IRB at
      UT Southwestern in accordance with 45 CFR 46, (b) the recipient agrees to comply fully with
      all such conditions and to report promptly to the CDRCC at UT Southwestern any proposed
      changes in the research project, (c) the recipient remains subject to applicable State or
      local laws or regulations and institutional policies which provide additional protections for
      human subjects, and (d) the research material may be utilized only in accordance with the
      conditions stipulated by the IRB at UT Southwestern. Any additional use of this material
      requires prior review and approval by the IRB at UT Southwestern and, where appropriate, by
      an IRB at the recipient site, which must be convened under an applicable OHRP-approved
      Assurance. Non-UT Southwestern recipients of samples will be charged a usual and customary
      fee for the sample to cover procurement costs.

      Under the supervision of the principal investigator of CDRCC, two different subcommittees
      will oversee the different aspects of the UTSW Depression Cohort: data management committee
      and executive committee. The data management committee will be tasked with managing the flow
      of information into and out of the Cohort database, maintaining the codebook of variables,
      developing big data tools (as mentioned in specific aim 3), and ensuring consistency of data
      collection and quality. The executive committee will be tasked with all other
      responsibilities related to the registry like establishing collaborations with providers,
      reviewing research proposals, and providing access to the cohort data for qualified
      researchers.

      All procedures will be conducted as part of a patient's routine medical care except for
      collection of research-only blood, urine, and saliva specimens as described above. This study
      does not involve any interventions.
    

Intervention name(s): No treatment
Intervention type(s): Other
Intervention description(s): This is an observational study with no intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The following groups are being targeted for this observational study:

          1. depressed patients,

          2. depressed patients with comorbid illnesses, and

          3. non-depressed patients.
      
Biospecimen description: 
      Biospecimens being studied is as follows:

        1. Blood

        2. Normal Tissue

        3. Saliva

        4. Urine

        5. Stool

        6. Clinical waste products to include surgical waste tissue samples, placenta samples, and
           biopsy samples.
    
Keywords: Depression; Cohort