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NCT04497415

The COVID-19 and Healthcare Workers: An Active Intervention

Completed NA Results posted Last updated 14 January 2022
What this trial tests

NA trial testing Video-Based intervention in Brief Video-based Intervention in 350 participants. Completed in 30 January 2021.

Timeline
21 October 2020
Primary endpoint
30 November 2020
30 January 2021

Quick facts

Lead sponsorResearch Foundation for Mental Hygiene, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment350
Start date21 October 2020
Primary completion30 November 2020
Estimated completion30 January 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Research Foundation for Mental Hygiene, Inc.

Who can join

Adults 18 to 80, any sex, with Brief Video-based Intervention or Non Intervention Control. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Help-seeking Behavior Primary · Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

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

Baseline
GroupValue95% CI
Video-based Intervention8.27.9 – 8.5
Assessment Only8.58.1 – 8.9
Post-intervention
GroupValue95% CI
Video-based Intervention9.39.0 – 9.6
Assessment Only8.78.2 – 9.1
First follow-up (day 14)
GroupValue95% CI
Video-based Intervention9.79.4 – 10.0
Assessment Only9.38.9 – 9.7
Second follow-up (day 30)
GroupValue95% CI
Video-based Intervention9.49.1 – 9.7
Assessment Only9.18.8 – 9.5
Generalized Anxiety Disorder-7 (GAD-7) Primary · Assessed at baseline, 14-day follow-up, and 30-day follow-up

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

Baseline (day 1)
GroupValue95% CI
Video-based Intervention7.6± 5.9
Assessment Only6.7± 6.1
First follow-up (day 14)
GroupValue95% CI
Video-based Intervention6.9± 6.0
Assessment Only5.9± 5.2
Second follow-up (day 30)
GroupValue95% CI
Video-based Intervention6.5± 5.7
Assessment Only5.4± 5.3
Patient Health Questionnaire-9 (PHQ-9) Primary · Assessed at baseline, 14-day follow-up, and 30-day follow-up

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

Baseline (day 1)
GroupValue95% CI
Video-based Intervention7.9± 6.6
Assessment Only6.6± 5.6
First follow-up (day 14)
GroupValue95% CI
Video-based Intervention7.4± 6.7
Assessment Only6.0± 5.7
Second follow-up (day 30)
GroupValue95% CI
Video-based Intervention7.0± 6.2
Assessment Only5.4± 5.7
Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen Primary · Assessed at baseline, 14-day follow-up, and 30-day follow-up

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

Baseline (day 1)
GroupValue95% CI
Video-based Intervention1.9± 1.6
Assessment Only1.8± 1.7
First follow-up (day 14)
GroupValue95% CI
Video-based Intervention1.8± 1.6
Assessment Only1.2± 1.5
Second follow-up (day 30)
GroupValue95% CI
Video-based Intervention1.7± 1.7
Assessment Only1.4± 1.6
Moral Injury Events Scale (MIES) Primary · Assessed at baseline, 14-day follow-up, and 30-day follow-up

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

Baseline (day 1)
GroupValue95% CI
Video-based Intervention18.1± 6.4
Assessment Only17.1± 6.6
First follow-up (day 14)
GroupValue95% CI
Video-based Intervention18.1± 6.8
Assessment Only16.5± 6.3
Second follow-up (day 30)
GroupValue95% CI
Video-based Intervention17.5± 6.7
Assessment Only16.5± 6.9

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Video intervention to increase treatment-seeking by healthcare workers during the COVID-19 pandemic: randomised controlled trial.
    Amsalem D, Lazarov A, Markowitz JC, Smith TE, et al · · 2022 · cited 26× · PMID 35045900 · DOI 10.1192/bjp.2021.54
  2. COVID 19 pandemic challenges and their management: A review of medicines, vaccines, patents and clinical trials with emphasis on psychological health issues.
    Mohapatra S, Ayash Kumar P, Farooq U, Jain P, et al · · 2022 · cited 3× · PMID 35645588 · DOI 10.1016/j.jsps.2022.05.004

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