The Pitt Center for Emergency Responder Wellness

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357586
• Other study ID #: STUDY21120152
• Status: Completed
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Anxiety
• Depression
• Emergencies
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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.	The WSAS will be administered at baseline and post-treatment (up to 20 weeks).
Secondary	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.	The WSAS will be administered at baseline and follow-up (7 months post-baseline).
Secondary	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.	The WHOQOL-BREF will be administered at baseline and post-treatment (up to 20 weeks).
Secondary	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.	The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).

External Links

•   Project website