Negative-Positive Valence Domains in Anxiety and Depression

Completed

• Conditions: Depression; Anxiety
• Interventions: Behavioral: NeuroImaging; Behavioral: Psychophysiological

• Registration Number: NCT03310398
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study Start: 2013-09-01
• Study First Submitted: 2015-10-23
• Primary Completion: 2017-04-30
• Study Completion: 2017-06-30
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-09
• Last Update Submitted: 2017-10-09
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anxiety	Psychophysiological	elevated anxiety (as indicated by a GAD-7 score of 8 or higher)
Depression	NeuroImaging	elevated anxiety (as indicated by a GAD-7 score of 8 or higher)
Anxiety	NeuroImaging	elevated anxiety (as indicated by a GAD-7 score of 8 or higher)
Depression	Psychophysiological	elevated anxiety (as indicated by a GAD-7 score of 8 or higher)

Primary Outcome Measures

Name	Time	Method
Relationship of latent constructs of positive and negative valence domains and neural indices of reward sensitivity and fear conditioning in treatment seeking depressed and anxious individuals.	4 years	Measure of BOLD % signal difference in brain regions of interest during reward or loss trials for anticipation and outcome phases in a reward paradigm, and conditioning trials in a fear conditioning paradigm.

Trial Locations

Locations (1)

UCSD Psychiatry Clinical Research; 🇺🇸 La Jolla, California, United States