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

NCT04351789 | Unknown

• 1 other identifier: PISCA Study
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; Mental Health; Psychoeducation; Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety 1 month

  Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

  1 month post discharge

Secondary Outcomes (6)

• Anxiety 3 months

  3 months post discharge

• Depression 3 months

  3 months post discharge

• Post Traumatic Stress Disorder (PTSD) symptoms 3 months

  3 months post discharge

• Anxiety 12 months

  12 months post discharge

• Post Traumatic Stress Disorder (PTSD) symptoms 12 months

  12 months post discharge

Study Arms (2)

Intervention Group

EXPERIMENTAL

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. The intervention is based on psychoeducational theory and consists of both written and verbal information. A manual describing the content and procedures of the intervention will be developed to ensure that the intervention is both replicable and transparent. The intervention has a planned duration of 30 minutes and will be conducted by a designated study affiliated researcher, who has a background in healthcare (i.e. nurse or medical doctor).

Other: Psychoeducational intervention

Control Group

NO INTERVENTION

Standard of Care at discharge of patients with COVID-19 from hospital is to inform the patients whom to contact in case of worsening of the physical condition, such as increasing e.g. shortness of breath, and of precautions regarding further isolation to avoid infection of household and other contacts, if relevant. Information regarding the patient´s psychological condition is not part of a standard conversation at discharge.

Interventions

Psychoeducational intervention OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age
• In-hospitalized with confirmed COVID-19 diagnosis,
• HADS-A score ≥8
• Able to read and understand Danish,
• Able to provide written informed consent

You may not qualify if:

• Patients with pulmonary cancer
• Patients who are terminally ill

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2600, Denmark

RECRUITING

Related Publications (24)

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Related Links

• World Health Organisation. Q\&A on coronaviruses (COVID-19)

MeSH Terms

Conditions

COVID-19; Psychological Well-Being; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior; Mental Disorders

Study Officials

• Nina Weis, MD, PhD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Weis, MD, PhD

CONTACT

+45 3862 3514; nina.weis@regionh.dk

Ellen Moseholm, MScH, PhD

CONTACT

+45 26702548; ellen.froesig.moseholm.larsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, the RCT trial is not blinded, but the outcome measures are masked for health professionals and staff until the end of the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Randomized 1:1 to either intervention group or control group

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 17, 2020
• Study Start: May 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)