The COVID-19 and Healthcare Workers: An Active Intervention

NCT04497415 | Completed Results

• 1 other identifier: 8032
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this study is to examine the efficacy of a brief video intervention in reducing stigma and fear, and improving help-seeking behavior, among health care providers (N=1,200), with pre- post- and follow-up assessments (at day 14 and day 30). Participants will be recruited via Amazon Turk and randomly assigned to either a) a video-based intervention (day 1 and a "booster intervention" of the same content on day 14 of the study) featuring the personal story of a health care provider during COVID-19 pandemic, his/her struggles and barriers to care, (b) video-based intervention (day 1 only), and a written description of the same story on day 14 (c) no-intervention control arm (questionnaires only). The invetsigators aim to (1) determine whether video-based intervention reduce stigma and fear, and increase help-seeking behavior in relation to COVID-19 among health care providers, and (2) compare high-risk areas (e.g., NY) to low-risk areas (e.g., Montana) on intervention outcomes, and (3) test whether symptoms of depression, anxiety, PTSD and Moral Injury (measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and the Moral Injury Events Scale (MIES)) would change over time.

Conditions

Brief Video-based Intervention; Non Intervention Control

Outcome Measures

Primary Outcomes (5)

• Help-seeking Behavior

  Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions

  Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

• Generalized Anxiety Disorder-7 (GAD-7)

  Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety

  Assessed at baseline, 14-day follow-up, and 30-day follow-up

• Patient Health Questionnaire-9 (PHQ-9)

  Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression

  Assessed at baseline, 14-day follow-up, and 30-day follow-up

• Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen

  Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms

  Assessed at baseline, 14-day follow-up, and 30-day follow-up

• Moral Injury Events Scale (MIES)

  Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury

  Assessed at baseline, 14-day follow-up, and 30-day follow-up

Study Arms (2)

Video-based intervention

EXPERIMENTAL

A brief video about coping with COVID-19 stress presented to the participants

Other: Video-Based intervention

Assessment only

NO INTERVENTION

Control

Interventions

Video-Based intervention OTHER

Three minutes video of a nurse that shares her personal story

Video-based intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speakers Healthcare workers aged 18-80 and residents of the USA.

You may not qualify if:

• Non-English speakers, non-healthcare workers, age less than 18 or more than 80, non-US residents

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Results Point of Contact

• Title: Yuval Y. Neria
• Organization: New York State Psychiatric Institute

ny126@cumc.columbia.edu

646-774-8092

Study Officials

• Yuval Neria, PhD

  Columbia University and NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medical psychology

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 4, 2020
• Study Start: October 21, 2020
• Primary Completion: November 30, 2020
• Study Completion: January 30, 2021
• Last Updated: January 14, 2022
• Results First Posted: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)