Reducing Stress in Primary Care Patients
|ClinicalTrials.gov Identifier: NCT03035019|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : December 6, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||593 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
This pilot will evaluate how the availability of a virtual stress management resource can help patients reduce anxiety and improve quality of life.
- GAD7 scores (anxiety) completion. [ Time Frame: 12 months ]GAD7 anxiety questionnaires are completed at time points throughout the study
- Patient satisfaction/acceptability post program [ Time Frame: 6 months after consent ]A measure to determine patient satisfaction of the Lantern program
- Quality of life (SF-12) [ Time Frame: 12 months ]SF-12 is a quality of life questionnaire participants complete.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035019
|United States, Pennsylvania|
|University of Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Eva Szigethy, MD, PHD||University of Pittsburgh|