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Reducing Stress in Primary Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035019
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Eva Szigethy, University of Pittsburgh

Brief Summary:

Stress and anxiety can worsen quality of life in patients seen in primary care practices. This project is set in UPMC primary care practices (CMI) to evaluate how the availability of a virtual stress management program can help patients reduce stress and anxiety and improve their quality of life. The project will analyze the efficacy of the virtual stress management program at these practices so that it can then be utilized effectively in other medical settings where it can be offered as a part of clinical care to reduce stress and anxiety and improve the quality of life of medical patients who could benefit from a reduction in stress. This research is being piloted at these sites in the hopes of publishing results that show that it can be implemented in other practices throughout the country.

Additionally, at other UPMC CMI primary care sites, de-identified data will be collected in order to serve as a comparison.


Condition or disease Intervention/treatment Phase
Stress Behavioral: Lantern Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 593 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reducing Stress in Primary Care Patients
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Lantern for primary care patients
All patients between the ages of 20-65 at specific primary care practices and score 5 or greater on the GAD7 questionnaire are offered the Lantern app to help with stress/anxiety.
Behavioral: Lantern
This pilot will evaluate how the availability of a virtual stress management resource can help patients reduce anxiety and improve quality of life.




Primary Outcome Measures :
  1. GAD7 scores (anxiety) completion. [ Time Frame: 12 months ]
    GAD7 anxiety questionnaires are completed at time points throughout the study

  2. Patient satisfaction/acceptability post program [ Time Frame: 6 months after consent ]
    A measure to determine patient satisfaction of the Lantern program


Secondary Outcome Measures :
  1. Quality of life (SF-12) [ Time Frame: 12 months ]
    SF-12 is a quality of life questionnaire participants complete.

  2. medical utilization [ Time Frame: 12 months ]
    Any medical treatment that occurred since consent, such as ER visits, # phone calls to practice, outpatient clinic visits and medical hospitalization days.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who are receiving or seeking medical care at UPMC CMI aged 20-65 who have a GAD7 score ≥ 5 must be English speaking and capable of understanding the informed consent and providing consent or assent and having access to a Smartphone.

Exclusion Criteria:

  • Patients under age 20 and older than 65 will be excluded. Patients whose GAD7 score is <5 will also be excluded. Patients who do not own a smartphone or mobile device will also not be included. Since this project is occurring at the same practices where a randomized study evaluating treatments for acute back pain (IRB Protocol # 015120249), patients with acute back pain will be excluded from this project.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035019


Locations
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United States, Pennsylvania
University of Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Eva Szigethy, MD, PHD University of Pittsburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Szigethy, MD, Phd, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03035019     History of Changes
Other Study ID Numbers: 16040173
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eva Szigethy, University of Pittsburgh:
anxiety
behavioral app