The Pitt Center for Emergency Responder Wellness

February 15, 2024 updated by: Eric Meyer, University of Pittsburgh

Serving Those Who Protect the Public: The Pitt Center for Emergency Responder Wellness

Emergency responders protect the public despite occupational hazards that threaten their mental health. The Pitt Center for Emergency Responder Wellness will be a clinical innovation hub that: 1) delivers accessible interventions for promoting mental health and overall wellbeing; 2) trains the next generation of students to provide mental health care for emergency responders; and 3) informs scientific understanding of post-trauma recovery processes. Goals for the seed phase are to establish our team and collect pilot data to demonstrate feasibility and initial clinical impact.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Emergency responders protect the public despite occupational hazards that threaten their mental health. This Center will be a clinical innovation hub that: 1) delivers accessible interventions for promoting mental health and overall wellbeing; 2) trains the next generation of graduate students to provide mental health care for emergency responders; and 3) informs scientific understanding of post-trauma recovery processes. Goals for the seed phase are to establish our team and collect pilot data to demonstrate feasibility and initial clinical impact. In this pilot study, the investigators will demonstrate feasibility by treating 30 eligible emergency responders (up to 60 total participants will be enrolled). The investigators will document treatment acceptability via treatment completion rates. The investigators will document treatment effects by measuring changes in mental health symptoms and quality of life. The investigators will disseminate our findings via conference presentations and manuscripts. The investigators will train graduate students in working with this specialized population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eric C Meyer, PhD
  • Phone Number: 4123836589
  • Email: ECM77@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants will be age 18 or older.
  2. They will be emergency responders defined as fire fighters, law enforcement officers, emergency medical service personnel, emergency room medical providers (physicians, nurses, physician assistants), emergency dispatchers, and emergency response trainees who have completed training experiences in which they encountered emergencies.
  3. They must reside in Pennsylvania.

Exclusion Criteria:

  1. Are unable or unwilling to complete the study procedures.
  2. Receiving another form of therapy our counseling for anxiety, depression, posttraumatic stress, or alcohol use problems. Attendance at self-help programs (e.g., Alcoholics Anonymous) and couples therapy is permitted.
  3. Have a history of a psychotic disorder or bipolar disorder.
  4. Endorse drug use and symptoms consistent with a non-alcohol substance use disorder except nicotine, caffeine, or cannabis.
  5. Are experiencing a current suicidal or homicidal crisis warranting immediate intervention: potential participants may participate later once stabilized.
  6. Are currently awaiting the outcome of litigation involving their employment or training as emergency responders or any other reason deemed by the study team to be potentially related to their mental health.
  7. Evidence severe organic brain impairment as evidenced by a major apparent disruption of consciousness, cognition, speech, or behavior that would likely interfere with treatment.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transdiagnostic cognitive behavioral therapy
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders is a manualized, evidence-based form of cognitive behavioral therapy aimed at targeting emotion regulation processes that underlie common forms of emotional disorders such as anxiety, depression, and commonly co-occurring mental health challenges.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline to post-treatment in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)
Time Frame: The PCL-5 will be administered at baseline and post-treatment (up to 20 weeks).
Self-reported posttraumatic stress disorder (PTSD) symptom severity measured using the PCL-5. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
The PCL-5 will be administered at baseline and post-treatment (up to 20 weeks).
Change from baseline to follow-up in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)
Time Frame: The PCL-5 will be administered at baseline and follow-up (7 months post-baseline).
Self-reported posttraumatic stress disorder (PTSD) symptom severity measured using the PCL-5. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
The PCL-5 will be administered at baseline and follow-up (7 months post-baseline).
Change from baseline to post-treatment in depressive symptom measured using the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: The PHQ-9 will be administered at baseline and post-treatment (up to 20 weeks).
Self-reported depression symptom severity will be measured using the Patient Health Questionnaire 9 Item-Depression (PHQ-9). Scores range from 0-27, with higher scores indicating greater severity of depression symptoms.
The PHQ-9 will be administered at baseline and post-treatment (up to 20 weeks).
Change from baseline to follow-up in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: The PHQ-9 will be administered at baseline and follow-up (7 months post-baseline).
Self-reported depression symptom severity will be measured using the Patient Health Questionnaire 9 Item-Depression (PHQ-9). Scores range from 0-27, with higher scores indicating greater severity of depression symptoms.
The PHQ-9 will be administered at baseline and follow-up (7 months post-baseline).
Change from baseline to post-treatment in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: The GAD-7 will be administered at baseline and post-treatment (up to 20 weeks).
Self-reported depression symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating greater anxiety symptom severity.
The GAD-7 will be administered at baseline and post-treatment (up to 20 weeks).
Change from baseline to follow-up in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: The GAD-7 will be administered at baseline and follow-up (7 months post-baseline).
Self-reported depression symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating greater anxiety symptom severity.
The GAD-7 will be administered at baseline and follow-up (7 months post-baseline).
Change from baseline to post-treatment in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: The AUDIT will be administered at baseline and post-treatment (up to 20 weeks).
Self-reported alcohol misuse measured using the Alcohol Use Disorders Identification Test (AUDIT). Scores range from 0-40 with higher scores indicating greater alcohol misuse.
The AUDIT will be administered at baseline and post-treatment (up to 20 weeks).
Change from baseline to follow-up in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: The AUDIT will be administered at baseline and follow-up (7 months post-baseline).
Self-reported alcohol misuse measured using the Alcohol Use Disorders Identification Test (AUDIT). Scores range from 0-40 with higher scores indicating greater alcohol misuse.
The AUDIT will be administered at baseline and follow-up (7 months post-baseline).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline to post-treatment in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
Time Frame: The WSAS will be administered at baseline and post-treatment (up to 20 weeks).
Self-reported functional impairment measured using the Work and Social Adjustment Scale (WSAS). Scores range from 0-8 with higher scores indicating more severe functional impairment.
The WSAS will be administered at baseline and post-treatment (up to 20 weeks).
Change from baseline to follow-up in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
Time Frame: The WSAS will be administered at baseline and follow-up (7 months post-baseline).
Self-reported functional impairment measured using the Work and Social Adjustment Scale (WSAS). Scores range from 0-8 with higher scores indicating more severe functional impairment.
The WSAS will be administered at baseline and follow-up (7 months post-baseline).
Change from baseline to post-treatment in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
Time Frame: The WHOQOL-BREF will be administered at baseline and post-treatment (up to 20 weeks).
Self-reported quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF). Scores range from 26 to 130 with higher scores indicating greater quality of life.
The WHOQOL-BREF will be administered at baseline and post-treatment (up to 20 weeks).
Change from baseline to follow-up in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
Time Frame: The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).
Self-reported quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF). Scores range from 26 to 130 with higher scores indicating greater quality of life.
The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eric C Meyer, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY21120152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data may be shared with other researchers at a future date, either directly or via online research repositories such as Open Science Framework.

Any necessary transfer agreements will be obtained through the office of research before any data is shared.

IPD Sharing Time Frame

The data will become available upon the date of the first publication.

IPD Sharing Access Criteria

Please contact the Project Director to request data access through a data use agreement.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

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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