Negative-Positive Valence Domains in Anxiety and Depression
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      Anxiety and depression are highly prevalent and disabling conditions that frequently
      co-occur, and are costly to the individual and society. Despite important advances in our
      understanding of these disorders, there is a significant unmet need to identify reliable and
      clinically useful tests that can predict prognosis, inform treatment choice for a given
      individual, and improve treatment outcomes. The aim of this project is to fill this critical
      gap by validating a battery of measures including brain imaging, psychophysiology, behavior,
      and self-report that will reliably assess positive and negative affect, or valence, system
      functioning in a broad sample of individuals screened for anxiety and depression as part of
      their routine primary care visits.
    

Detailed description: 
      Participants presenting to the UCSD and UCLA primary care clinics will be screened as part of
      their routine visit using the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety
      Disorder 7 (GAD-7). Participants who call in will be asked to provide verbal informed consent
      for phone screening and the IRB approved Screening Questionnaire and the Overall Anxiety
      Severity and Impairment Scale (OASIS) will be administered.

      Participants who remain eligible after the phone screening will be asked to return for a
      Clinical Interview, Behavioral Session, Biomarker blood draw, (and optional genetics), and
      Neuroimaging Session.

      All participants will be contacted approximately 3-months later and invited to complete the
      same battery of self-report measures completed during the baseline session (described below).
      The self-report measures will be administered through a secure on-line survey database. This
      data will allow investigators to (1) confirm that participants continue to meet initial
      eligibility criteria and are therefore eligible for the full re-test battery and (2) use
      baseline measures of positive and negative valence domains to predict changes in symptoms and
      functioning.

      A subset of 50 participants (n=25 from each UCSD and UCLA) will be randomly selected to
      return approximately three months later to complete the same battery of assessments in the
      Behavioral and Neuroimaging Sessions to establish test-retest reliability of the latent
      constructs.
    

Intervention name(s): NeuroImaging; Psychophysiological
Intervention type(s): Behavioral; Behavioral
Intervention description(s): standard anatomical and functional imaging; Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators opted to identify individuals with anxiety or depression in a primary care
        setting, which investigators have used successfully to recruit a significant number of
        subjects, to maximize generalizability and external validity.
      
Biospecimen description: 
      Blood biomarkers: Investigators will assess blood biomarkers including norepinephrine,
      dopamine, epinephrine, creatinine, soluble cellular adhesion molecules (sICAM, sVCAM), IFN+
      (IFN-gamma, IL-6, and TNF-alpha assayed together), and brain-derived neurotrophic factor
      (BDNF).

      Genetics: Furthermore, as noted later in this section of the application, investigators have
      identified abnormalities in functioning of key structures (e.g., amygdala and insula) within
      the brain's anxiety circuitry in anxiety-prone subjects and there is evidence that certain
      genes (e.g., SLC6A4) influence the extent of activation in these regions. The focus of this
      project is to determine to what extent variation in CRF system genes (i.e., CRF, CRF-R1,
      CRF-R2, UCN, UCN2, UCN3) is associated with anxiety disorders.