NCT03139357

Brief Summary

Stress and anxiety can worsen quality of life in patients seen in primary care practices. Patients at predetermined practices age 20-65 receive psychosocial screening instruments for anxiety and quality of life (GAD7 and SF-12) at six month intervals for twenty-four months as part of routine care. Assessing anxiety and quality of life every six months will provide data to analyze whether anxiety and quality of life changes over time. Patients who consent will also be asked at 6, 12, 18, and 24 months about medical utilization of behavioral care or any medical care outside of University of Pittsburgh Medical Center in order to be part of their research record for good clinical care. If patients received any behavioral treatment, the patient will also be asked questions regarding the helpfulness of this treatment. This is an observational characterization study to understand the psychiatric and behavioral needs of primary care patients. The follow-up questionnaires and medical record information will look at the rates and predictors of hospitalizations and/ or behavioral health treatment as a longitudinal way to track these symptoms over time. These resources are critical to determine the need for embedded behavioral care in primary care settings.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

January 25, 2017

Last Update Submit

December 5, 2018

Conditions

Life Stress

Outcome Measures

Primary Outcomes (1)

  • GAD7 score change over time

    mesures anxiety

    2 years (6, 12, 18, 24 months)

Secondary Outcomes (5)

  • SF-12 score change over time

    2 years (6, 12, 18, 24 months)

  • Medical hospitalization days change over time

    2 years (6, 12, 18, 24 months)

  • ER visits change over time

    2 years (6, 12, 18, 24 months)

  • Outpatient clinic visits change over time

    2 years (6, 12, 18, 24 months)

  • Number of phone calls to practice change over time

    2 years (6, 12, 18, 24 months)

Study Arms (1)

Primary care patients

Patients ages 20-65 who score 5 or greater on the GAD-7 will be given the SF12, GAD7, medial utilization, and helpfulness questionnaires at 6 month intervals for a 2 year period.

Other: GAD7, SF12, medical utilization, helpfulness questionnaire

Interventions

GAD7, SF12, medical utilization, helpfulness questionnaireOTHER

The questionnaires are administered to track stress level and medical utilization over a 2 year period.

Primary care patients

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients ages 20-65 at designated UPMC primary care sites who score 5 or greater on the GAD7 (anxiety) questionnaire. This questionnaire is given as part of routine care.

You may qualify if:

  • receiving or seeking medical care at UPMC CMI
  • ages 20-65
  • GAD7 (anxiety questionnaire) score ≥ 5
  • Speaks English speaking
  • Capable of understanding and providing consent or assent

You may not qualify if:

  • under age 20 and older than 65
  • GAD7 score \<5
  • patients with acute back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eva Szigethy, MD PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

January 25, 2017

First Posted

May 3, 2017

Study Start

December 22, 2016

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations

US(1)