Clinical trial NCT05357586: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Depression
Anxiety
Alcohol Use Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, uncontrolled, pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to post-treatment in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: The PCL-5 will be administered at baseline and post-treatment (up to 20 weeks).
measure: Change from baseline to follow-up in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: The PCL-5 will be administered at baseline and follow-up (7 months post-baseline).
measure: Change from baseline to post-treatment in depressive symptom measured using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: The PHQ-9 will be administered at baseline and post-treatment (up to 20 weeks).
measure: Change from baseline to follow-up in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: The PHQ-9 will be administered at baseline and follow-up (7 months post-baseline).
measure: Change from baseline to post-treatment in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: The GAD-7 will be administered at baseline and post-treatment (up to 20 weeks).
measure: Change from baseline to follow-up in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: The GAD-7 will be administered at baseline and follow-up (7 months post-baseline).
measure: Change from baseline to post-treatment in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: The AUDIT will be administered at baseline and post-treatment (up to 20 weeks).
measure: Change from baseline to follow-up in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: The AUDIT will be administered at baseline and follow-up (7 months post-baseline).
Secondary outcomes:
measure: Change from baseline to post-treatment in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
timeFrame: The WSAS will be administered at baseline and post-treatment (up to 20 weeks).
measure: Change from baseline to follow-up in functional impairment measured using the Work and Social Adjustment Scale (WSAS)
timeFrame: The WSAS will be administered at baseline and follow-up (7 months post-baseline).
measure: Change from baseline to post-treatment in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
timeFrame: The WHOQOL-BREF will be administered at baseline and post-treatment (up to 20 weeks).
measure: Change from baseline to follow-up in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF).
timeFrame: The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eric C Meyer, PhD
role: STUDY_DIRECTOR
References: