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NCT Number: NCT05976347

Identifying and Treating Depression in the Orthopaedic Trauma Population

The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. The main questions it aims to answer are:

1. What are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI). 2. What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Erica Grochowski, MPH

CONTACT

[email protected]

704-403-4980

About this study

Depression is common among orthopaedic trauma patients and associated with worsened outcomes including pain, opioid consumption, patient-reported outcomes ,complications, and length of stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic surgeons may believe treating depression is outside their scope or that they lack tools to address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen patients, and only 27% are likely to refer patients for psychological treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting to an Orthopaedic trauma clinic for the first time following operative extremity fracture or any pelvis fracture
  • A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at first post- operative visit
  • Age 18 or older
  • Speak English or Spanish

Exclusion criteria

  • Currently taking medication to treat depression
  • Contraindication/allergy to one of the study medications
  • Bipolar disorder of psychotic disorder
  • Endorse suicidal ideation

Treatment and study plan

Fluoxetine 20 mg

Drug

Fluoxetine 20 mg once daily

Other names: Prozac Weekly, Sarafem, Prozac

Duloxetine 30 MG

Drug

Duloxetine 30 mg once daily

Other names: Irenka and Cymbalta

observation

Other

Referral to behavioral health and resources for addressing depressive symptoms

Other names: Referral to behavioral health and resources

Primary outcomes

  1. Depressive Symptom Scores

    Time frame: Baseline

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  2. Depressive Symptom Scores

    Time frame: Month 3

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  3. Depressive Symptom Scores

    Time frame: Month 6

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  4. Depressive Symptom Scores

    Time frame: Month 9

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  5. Depressive Symptom Scores

    Time frame: Year 1

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

Secondary outcomes

  1. Adherence to Treatment Percentage

    Time frame: Months 3, 6, and 12

    Adherence to treatment and side effects or adverse events associated with the medications will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of prescriptions filled).

  2. Utilization of non-pharmaceutical tools and resources Percentage

    Time frame: Months 3, 6, and 12

    Engagement with behavioral health resources will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of visits with Behavioral Health).

  3. Patient Reported Outcome Measures - PROMIS-29 Scores

    Time frame: Months 3, 6, and 12

    The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean a higher level of disability.

  4. Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores

    Time frame: Months 3, 6, and 12

    The Work Productivity and Activity Impairment questionnaire measures how work productivity and activities are impaired by a specific health condition or disease. Scores are expressed as a percentage of impairment/productivity loss, a high score indicates greater impairment.

  5. Patient Reported Outcome Measures - Brief Pain Inventory Scores

    Time frame: Months 3, 6, and 12

    Assesses the severity of pain and the impact of pain on daily functions. Assesses the severity of and impact of pain on daily function. Patients are asked to rate their current symptoms, average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 1-10. A total pain severity score can be found by averaging these items or a single items can be treated as the primary outcome. Higher scores indicate greater severity and more interference.

  6. Healthcare Utilization - The number of hospitalizations and ED visits

    Time frame: Months 3, 6, and 12

    The number of hospitalizations and ED visits

  7. Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Months 3, 6, and 12

    A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression. The higher the score, the more symptoms of depression experienced, and the more severe the depression is.

  8. Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)

    Time frame: Months 3, 6, and 12

    Measures health related quality of life across 7 domains. The answers are summarized into two scores - a Physical Component Score and a Mental Component Score.

  9. Qualitative Interview Information

    Time frame: One time between 6-12 months

    Patients in the observational arm will participate in semi-structured interviews. Interviews will be recorded and transcribed verbatim within one week. Field notes will be written within one week of each interview, and the interview guide will be revised as appropriate.

Study contacts

Contact information is provided by the study sponsor or research team.

Erica Grochowski, MPH

CONTACT

[email protected]

704-403-4980

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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