Negative-Positive Valence Domains in Anxiety and Depression (RDoC)

Latent Constructs: Negative-Positive Valence Domains in Anxiety and Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: NeuroImaging; Behavioral: Psychophysiological

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 Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0855
      • UCSD Psychiatry Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

1. Positive for anxiety and/or depressive symptoms.
2. Score on the PHQ-9 and OASIS.
3. Between the ages of 18-55, inclusive.
4. Have signed informed consent document(s) indicating that participant understands the purpose of and procedures required for the study and willing to participate in the study.
5. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.
6. Have telephone or easy access to telephone.
7. History of brain injury with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider).
8. Current and regular use of a medication that could affect brain functioning.
9. Must not have MRI contraindications such as: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body piercings, and pregnancy.
10. Intact or correctable vision and hearing.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anxiety; elevated anxiety (as indicated by a GAD-7 score of 8 or higher)	Behavioral: NeuroImaging; standard anatomical and functional imaging; Behavioral: Psychophysiological; Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram
Depression; elevated anxiety (as indicated by a GAD-7 score of 8 or higher)	Behavioral: NeuroImaging; standard anatomical and functional imaging; Behavioral: Psychophysiological; Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 years

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Martin P Paulus, MD, UC San Diego; Principal Investigator: Murray B Stein, MD, MPH, UC San Diego

Publications and helpful links

General Publications

• Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
• Roy-Byrne P, Craske MG, Sullivan G, Rose RD, Edlund MJ, Lang AJ, Bystritsky A, Welch SS, Chavira DA, Golinelli D, Campbell-Sills L, Sherbourne CD, Stein MB. Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial. JAMA. 2010 May 19;303(19):1921-8. doi: 10.1001/jama.2010.608.
• Insel T, Cuthbert B, Garvey M, Heinssen R, Pine DS, Quinn K, Sanislow C, Wang P. Research domain criteria (RDoC): toward a new classification framework for research on mental disorders. Am J Psychiatry. 2010 Jul;167(7):748-51. doi: 10.1176/appi.ajp.2010.09091379. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (ACTUAL): October 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 130554