NCT03035019

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
593

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

January 20, 2017

Last Update Submit

December 5, 2018

Conditions

Stress

Keywords

anxietybehavioral app

Outcome Measures

Primary Outcomes (2)

  • GAD7 scores (anxiety) completion.

    GAD7 anxiety questionnaires are completed at time points throughout the study

    12 months

  • Patient satisfaction/acceptability post program

    A measure to determine patient satisfaction of the Lantern program

    6 months after consent

Secondary Outcomes (2)

  • Quality of life (SF-12)

    12 months

  • medical utilization

    12 months

Study Arms (1)

Lantern for primary care patients

EXPERIMENTAL

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

Interventions

LanternBEHAVIORAL

This pilot will evaluate how the availability of a virtual stress management resource can help patients reduce anxiety and improve quality of life.

Lantern for primary care patients

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Szigethy E, Solano F, Wallace M, Perry DL, Morrell L, Scott K, Bell MJ, Oser M. A study protocol for a non-randomised comparison trial evaluating the feasibility and effectiveness of a mobile cognitive-behavioural programme with integrated coaching for anxious adults in primary care. BMJ Open. 2018 Jan 13;8(1):e019108. doi: 10.1136/bmjopen-2017-019108.

    PMID: 29331971DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

nano-lantern protein

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Eva Szigethy, MD, PHD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 27, 2017

Study Start

July 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

US(1)