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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
Medical Music
BehavioralParticipants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
Narrative Writing
BehavioralParticipants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
Prolonged Exposure Therapy
BehavioralPsychotherapy including imaginal exposure for PTSD
Interpersonal Psychotherapy
BehavioralPsychotherapy that focuses on the effects of PTSD on current interpersonal functioning
Treatment groups
Trial outcomes
Primary outcomes
Feasibility Indicator: Recruitment (Phase I)
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Recruitment (Phase II)
Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment (Phase I)
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Enrollment (Phase II)
Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Secondary outcomes
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.
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.
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
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.
Sponsors and contacts
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