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

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ClinicalTrials.gov Identifier: NCT04351789
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nina Weis, Copenhagen University Hospital, Hvidovre

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.


Condition or disease Intervention/treatment Phase
COVID-19 Mental Health Psychoeducation Anxiety Other: Psychoeducational intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1 to either intervention group or control group
Masking: Single (Outcomes Assessor)
Masking Description: 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
Primary Purpose: Prevention
Official Title: Impact of a Minimal Psychoeducational Intervention Versus Standard of Care on Anxiety Among Hospitalized COVID-19 Patients in Denmark: a Randomized Clinical Trial
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention 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. 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

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.


No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Anxiety 1 month [ Time Frame: 1 month post discharge ]
    Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.


Secondary Outcome Measures :
  1. Anxiety 3 months [ Time Frame: 3 months post discharge ]
    Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

  2. Depression 3 months [ Time Frame: 3 months post discharge ]
    Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

  3. Post Traumatic Stress Disorder (PTSD) symptoms 3 months [ Time Frame: 3 months post discharge ]
    PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

  4. Anxiety 12 months [ Time Frame: 12 months post discharge ]
    Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

  5. Post Traumatic Stress Disorder (PTSD) symptoms 12 months [ Time Frame: 12 months post discharge ]
    PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

  6. Depression 12 months [ Time Frame: 12 months post discharge ]
    Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with pulmonary cancer
  • Patients who are terminally ill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351789


Contacts
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Contact: Nina Weis, MD, PhD +45 3862 3514 nina.weis@regionh.dk
Contact: Ellen Moseholm, MScH, PhD +45 26702548 ellen.froesig.moseholm.larsen@regionh.dk

Locations
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Denmark
Copenhagen University Hospital, Hvidovre Recruiting
Hvidovre, Denmark, 2600
Contact: Nina Weis, MD, PhD    +45 3862 3514    nina.weis@regionh.dk   
Contact: Ellen Moseholm, PhD    +45 26702548    ellen.froesig.moseholm.larsen@regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Principal Investigator: Nina Weis, MD, PhD Copenhagen University Hospital, Hvidovre
Additional Information:
Publications:

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Responsible Party: Nina Weis, Professor, MD, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT04351789    
Other Study ID Numbers: PISCA Study
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers due to regulatory restrictions.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders