Back to resultsThe Pitt Center for Emergency Responder Wellness
Primary Purpose
Posttraumatic Stress Disorder, Depression, Anxiety
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transdiagnostic cognitive behavioral therapy
Arm Description
Transdiagnostic cognitive behavioral therapy
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Change from baseline to post-treatment in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
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.
Change from baseline to follow-up in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
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.
Change from baseline to post-treatment in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
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.
Change from baseline to follow-up in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05357586
Brief Title
The Pitt Center for Emergency Responder Wellness
Official Title
Serving Those Who Protect the Public: The Pitt Center for Emergency Responder Wellness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression, Anxiety, Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, uncontrolled, pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transdiagnostic cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Transdiagnostic cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline to post-treatment in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
The PCL-5 will be administered at baseline and post-treatment (up to 20 weeks).
Title
Change from baseline to follow-up in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
The PCL-5 will be administered at baseline and follow-up (7 months post-baseline).
Title
Change from baseline to post-treatment in depressive symptom measured using the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
The PHQ-9 will be administered at baseline and post-treatment (up to 20 weeks).
Title
Change from baseline to follow-up in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
The PHQ-9 will be administered at baseline and follow-up (7 months post-baseline).
Title
Change from baseline to post-treatment in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
The GAD-7 will be administered at baseline and post-treatment (up to 20 weeks).
Title
Change from baseline to follow-up in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
The GAD-7 will be administered at baseline and follow-up (7 months post-baseline).
Title
Change from baseline to post-treatment in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT)
Description
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.
Time Frame
The AUDIT will be administered at baseline and post-treatment (up to 20 weeks).
Title
Change from baseline to follow-up in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT)
Description
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.
Time Frame
The AUDIT will be administered at baseline and follow-up (7 months post-baseline).
Secondary Outcome Measure Information:
Title
Change from baseline to post-treatment in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
Description
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.
Time Frame
The WSAS will be administered at baseline and post-treatment (up to 20 weeks).
Title
Change from baseline to follow-up in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
Description
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.
Time Frame
The WSAS will be administered at baseline and follow-up (7 months post-baseline).
Title
Change from baseline to post-treatment in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
Description
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.
Time Frame
The WHOQOL-BREF will be administered at baseline and post-treatment (up to 20 weeks).
Title
Change from baseline to follow-up in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
Description
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.
Time Frame
The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C Meyer, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.shrs.pitt.edu/mscrmhc/pitt-center-emergency-responder-wellness
Description
Project website
Learn more about this trial
The Pitt Center for Emergency Responder Wellness
We'll reach out to this number within 24 hrs