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Negative-Positive Valence Domains in Anxiety and Depression

NCT ID: NCT03310398

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Anxiety Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anxiety

elevated anxiety (as indicated by a GAD-7 score of 8 or higher)

NeuroImaging

Intervention Type BEHAVIORAL

standard anatomical and functional imaging

Psychophysiological

Intervention Type BEHAVIORAL

Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram

Depression

elevated anxiety (as indicated by a GAD-7 score of 8 or higher)

NeuroImaging

Intervention Type BEHAVIORAL

standard anatomical and functional imaging

Psychophysiological

Intervention Type BEHAVIORAL

Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram

Interventions

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NeuroImaging

standard anatomical and functional imaging

Intervention Type BEHAVIORAL

Psychophysiological

Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Martin Paulus

Adjunct Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin P Paulus, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Murray B Stein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

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UCSD Psychiatry Clinical Research

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20595427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12813115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20483968 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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130554

Identifier Type: -

Identifier Source: org_study_id