General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma.

There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.

After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any healthcare worker providing medical care or support who has experienced occupational-related trauma

English-speaking

Age >18

Medically stable

Disqualifiers

Current significant unstable medical illness precluding regular session attendance or assessment completion

Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk

Lifetime or current diagnosis of schizophrenia or other psychotic disorder

Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Medical Music

    Behavioral

    Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks

  • Narrative Writing

    Behavioral

    Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks

  • Prolonged Exposure Therapy

    Behavioral

    Psychotherapy including imaginal exposure for PTSD

  • Interpersonal Psychotherapy

    Behavioral

    Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Medical Music (Phase I)Experimental treatment 1 intervention
Group B: Narrative Writing (Phase I)Experimental treatment 1 intervention
Group C: Interpersonal Psychotherapy (Phase II)Active comparator 1 intervention
Group D: Prolonged Exposure Therapy (Phase II)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility Indicator: Recruitment (Phase I)

Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.

Time frame
Baseline
2

Feasibility Indicator: Recruitment (Phase II)

Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.

Time frame
Post-Phase I Assessment at week 2
3

Feasibility Indicator: Enrollment (Phase I)

Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

Time frame
Baseline
4

Feasibility Indicator: Enrollment (Phase II)

Feasibility assessment will include enrollment defined as number of individuals beginning phase II.

Time frame
Post-Phase I Assessment at approximately week 2

Secondary outcomes

1

Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)

Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity.

Time frame
Start of Phase I to approximately 2 weeks
2

Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)

Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity.

Time frame
Start of Phase II to approximately 5 weeks
3

Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)

16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity

Time frame
Start of Phase I to approximately 2 weeks
4

Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)

16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity.

Time frame
Start of Phase II to approximately 5 weeks

Other outcomes

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