AzTrials
AzTrials

Posttraumatic Stress DisorderCO-CarESNCT04409821

Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care

A study testing Tele-delivered psychological intervention in people with Posttraumatic Stress Disorder and Prolonged Grief Disorder, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tele-delivered psychological intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesDenmark
Study dates
29 May 2020to 31 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • close relatives or friends of a patient hospitalized in an intensive care or intermediary care wards with COVID-19
  • capable of completing online questionnaires
  • speak Danish sufficiently for a therapeutic dialogue
  • provide informed consent

Who cannot join

  • suffering from a severe psychiatric disorder (such as schizophrenia) or in ongoing psychotherapeutic treatment for a psychiatric disorder (such as major depression generalized anxiety disorder or others), that cannot be paused
  • unable to complete verbal phone- or videoconferencing calls
  • unable to complete electronic questionnaires

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Denmark6 sites

  • Skejby Hospital

    Aarhus

  • Rigshospitalet

    Copenhagen, 2100

  • Hospitalsenheden Vest, Horsens

    Horsens

  • Hvidovre Hospital

    Hvidovre

  • Sygehus Lillebælt, Kolding

    Kolding

  • Odense University Hospital

    Odense

Other trials in Denmark

About this study

Official title: COVID-19 Caregiver Emotional Support

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

Being tested
Tele-delivered psychological intervention
Keywords
Informal caregiver, COVID-19
Medical subject headings
Stress Disorders, Post-Traumatic, Prolonged Grief Disorder, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-delivered psychological interventionBehavioural

    The intervention consists of two (or one, if preferred by caregivers) weekly tele-sessions during the ICU stay, lasting up to 30 minutes, and two sessions in the month after discharge from or death in the ICU. Sessions will be conducted via phone-calls or video-conferencing. Therapists will 1) validate caregivers' subjective experience, 2) normalize and psychoeducate about emotional reactions, and 3) offer emotion regulation drawing on contemporary cognitive treatment packages of decentering, acceptance and emotion tolerance. Sessions for bereaved caregivers will include psycho-education about grief, assessment of risk for adverse outcomes and information about available support, if needed. The intervention will be performed based on an intervention manual. The content of the intervention will be continually adapted and tailored to the needs of the participating caregivers by involving all caregivers in co-creating the intervention trough brief post-session interviews.

Study groups in NCT04409821
Study groupRoleWhat they receive
Tele-delivered psychological interventionExperimentalWeekly tele-delivered psychological intervention
Receives: Behavioral: Tele-delivered psychological intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Rate of consent among informed eligible participants

    Measured: At inclusion

  2. Completion rate

    Rates of completion of intervention sessions among participants

    Measured: During and post-intervention (1 month)

  3. Peri-traumatic distress inventory (negative emotions)

    Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress

    Measured: Pre-post intervention (1 month after discharge/death)

  4. Impact of Events Scale (6 item)

    Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

    Measured: 1 month post intervention

  5. Impact of Events Scale (6 item)

    Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

    Measured: 6 months post intervention

  6. Impact of Events Scale (6 item)

    Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

    Measured: 12/13 months post intervention

Secondary outcomes (4)

  1. Prolonged Grief-13-scale

    Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder

    Measured: 6 and 13 months

  2. PROMIS Depression (8 item scale)

    Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms

    Measured: Baseline to 1, 6, and 12/13 months

  3. PROMIS Anxiety (8 item scale)

    Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms

    Measured: Baseline to 1, 6, and 12/13 months

  4. Perceived Stress Scale (4 item)

    Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress

    Measured: Baseline to 1, 6, and 12/13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start29 May 2020
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04409821
Sponsor's protocol ID
P-2020-544
Other IDs
0216-00030B
Acronym
CO-CarES
Status last verified
Nov 2023
First submitted
22 May 2020
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • von Heymann A, Nissen ER, Agard AS, Egerod I, Kokla M, Farver-Vestergaard I, Prigerson HG, Lichtenthal WG, Johansen C, Zachariae R, O'Toole MS. Tele-delivered psychotherapeutic intervention for family members of patients in intensive care: a nonrandomized pilot study. Ann Am Thorac Soc. 2026 May 1;23(5):782-790. doi: 10.1093/annalsats/aaoag015.

    PubMed 41721750

Questions about this trial

What is this clinical trial studying?

A study testing Tele-delivered psychological intervention in people with Posttraumatic Stress Disorder and Prolonged Grief Disorder, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: At inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04409821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in