Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool

July 31, 2026 updated by: Methodist Health System

Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using Patient Health Questionnaire-9 as a Screening Tool

The objective of the study is to complete a retrospective chart review of subjects who were treated at the Wound Care Clinic at Methodist Dallas Medical Center, presented for treatment between June 2018 and February 2019, and were administered the Patient Health Questionnaire-9. The study aims to measure the prevalence of depression in this sample, feasibility of using Patient Health Questionnaire-9 in this patient population, and identifying variables and functional impairment associated with clinically significant depression.

Study Overview

Status

Completed

Conditions

Detailed Description

The study will review medical records of new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019. These patients were all administered Patient Health Questionnaire-9 as part of a quality improvement project. The medical records included for analysis will be from male and female patients aged 18 years or older. The medical records will be reviewed for the following information: general demographics, information including age, sex, ethnicity, race, Patient Health Questionnaire-9 score (total and individual items), medical conditions, wound history, past medical history, general symptoms, abuse and suicide risk, activities of daily living, motivation assessment, mental status, and pain ratings. This information will be used to measure the prevalence of clinically significant depression in the sample, which is the primary aim. We will also use the data to establish factors and variables correlated with the presence and severity of clinically significant depression.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75203
        • Wound care & Hyperbaric Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019.

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Received care at the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019
  3. Completed a PHQ-9 form at the time of initial evaluation/examination

Exclusion Criteria:

1. Patients less than 18 years of age will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-9 score
Time Frame: Through study completion, an average of 1 year
to measure the prevalence of clinically significant depression defined as a PHQ-9 score of equal to or greater than 10.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Asma Khatoon, MD, The Methodist Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Actual)

May 11, 2021

Study Completion (Actual)

May 11, 2021

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 055.WCHC.2019.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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