General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04626050
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

It is expected that large numbers of healthcare workers will 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 caring for COVID-19 patients. 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.

Key Dates

Start date
Jan 20, 2022
Status verified
Jul 2025
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Medical Music (Phase I)
    Participants will complete four medical music sessions that are 20 minutes in length each.
  • Experimental: Narrative Writing (Phase I)
    Participants will complete four narrative writing sessions that are 20 minutes in length each.
  • Active Comparator: Interpersonal Psychotherapy (Phase II)
    IPT is comprised of ten 75-minute sessions scheduled twice weekly.
  • Active Comparator: Prolonged Exposure Therapy (Phase II)
    ET is comprised of ten 75-minute sessions scheduled twice weekly.

Primary Outcome Measure

Feasibility Indicator: Recruitment (Phase I) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Olivia Baryluk, BS
JoAnn Difede, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Weill Cornell Medicine· New York, NY

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