NCT05357586

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 29, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

April 20, 2022

Last Update Submit

February 15, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change from baseline to post-treatment in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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 Outcomes (4)

  • Change from baseline to post-treatment in functional impairment measured using the Work and Social Adjustment Scale (WSAS)

    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)

    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).

    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).

    The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).

Study Arms (1)

Transdiagnostic cognitive behavioral therapy

EXPERIMENTAL

Transdiagnostic cognitive behavioral therapy

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Interventions

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.

Transdiagnostic cognitive behavioral therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be age 18 or older.
  • 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.
  • They must reside in Pennsylvania.

You may not qualify if:

  • Are unable or unwilling to complete the study procedures.
  • 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.
  • Have a history of a psychotic disorder or bipolar disorder.
  • Endorse drug use and symptoms consistent with a non-alcohol substance use disorder except nicotine, caffeine, or cannabis.
  • Are experiencing a current suicidal or homicidal crisis warranting immediate intervention: potential participants may participate later once stabilized.
  • 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.
  • Evidence severe organic brain impairment as evidenced by a major apparent disruption of consciousness, cognition, speech, or behavior that would likely interfere with treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • Meyer EC, Roth SG, Coe E, Taylor DJ, Gulliver SB. Pilot outcomes and exploration of treatment mechanisms using a culturally adapted version of the unified protocol for transdiagnostic treatment of emotional disorders to improve mental health symptoms, alcohol misuse, functional outcomes, and sleep quality in emergency responders. Front Health Serv. 2025 Jun 16;5:1452976. doi: 10.3389/frhs.2025.1452976. eCollection 2025.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety DisordersAlcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Eric C Meyer, PhD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group, uncontrolled, pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 3, 2022

Study Start

March 29, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
Time Frame
The data will become available upon the date of the first publication.
Access Criteria
Please contact the Project Director to request data access through a data use agreement.

Locations