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Impact of a Minimal Psychoeducational Intervention on Anxiety Among Hospitalized COVID-19 Patients in Denmark

NCT04351789 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-08-24

No results posted yet for this study

Summary

Background: There is limited knowledge on the psychological implications of COVID-19 among hospitalized patients and their close relatives. Moreover, evidence-based psychological interventions targeting hospitalized COVID-19 patients and their relatives are currently lacking.

Objective: To test a minimal psychoeducational intervention versus standard of care for reducing anxiety among hospitalized COVID-19 patients.

Methods and analysis: The trial is a Randomized Controlled Trial (RCT) with a 1 month and 3 month follow-up. Hospitalized COVID-19 patients are consecutively included at admission and randomized 1:1 to either an intervention or control group. Patients randomized to the intervention group will receive a minimal psychoeducational intervention just prior to discharge from the hospital. The goal of the intervention is that patients will be prepared and learn to interpret and react to physical and psychological symptoms that are related to recovering from a COVID-19 infection. Data is collected using standardized and validated patient reported outcome measures (PROMs) to assess mental health outcomes. The primary outcome is patient reported anxiety as assess by the Hospital Anxiety and Depression Scale.

Perspectives: This study will provide a comprehensive understanding of the psychological implications of the COVID-19 outbreak. If successful, the minimal intervention is easily implemented in daily clinical practice.

Conditions

Interventions

OTHER

Psychoeducational intervention

The written and verbal information provided at discharge to patients in the intervention arm will consist of: An explanation of the normal recovery period after hospitalization due to COVID-19. What can the patient expect physically, psychologically and emotionally, and what coping mechanism might be appropriate Social support in the recovery period and how this can be used constructively. In case of worsening of symptoms - physically or psychologically, where can the patient get help after discharge from hospital. These points are based on crisis psychology, enhancing the patients empowerment and self-management after discharge from hospital.

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Principal Investigators

  • Nina Weis, MD, PhD · Copenhagen University Hospital, Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351789 on ClinicalTrials.gov