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.
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
- Conditions the study is for
- Posttraumatic Stress Disorder, Prolonged Grief Disorder, COVID
- What is being tested?
- Tele-delivered psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Tele-delivered psychological intervention | Experimental | Weekly 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.
Recruitment rate
Rate of consent among informed eligible participants
Measured: At inclusion
Completion rate
Rates of completion of intervention sessions among participants
Measured: During and post-intervention (1 month)
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)
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
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
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)
Prolonged Grief-13-scale
Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder
Measured: 6 and 13 months
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
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
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.
- First posted1 Jun 2020
- Study start29 May 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annika von Heymann, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Annika von Heymann, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Caregiver Emotional Support
- ClinicalTrials.gov ID
- NCT04409821
- Acronym / sponsor ID
- CO-CarES / P-2020-544
- Keywords
- Informal caregiver, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Tele-delivered psychological intervention | Experimental | Behavioral: Tele-delivered psychological interventionWeekly tele-delivered psychological intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-delivered psychological interventionThe 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. | Behavioural | Tele-delivered psychological intervention |
Primary outcome
Recruitment rate
Time frame: At inclusion
Rate of consent among informed eligible participants
Completion rate
Time frame: During and post-intervention (1 month)
Rates of completion of intervention sessions among participants
Peri-traumatic distress inventory (negative emotions)
Time frame: Pre-post intervention (1 month after discharge/death)
Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress
Impact of Events Scale (6 item)
Time frame: 1 month post intervention
Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
Impact of Events Scale (6 item)
Time frame: 6 months post intervention
Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
Impact of Events Scale (6 item)
Time frame: 12/13 months post intervention
Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
4 secondary outcomes
Prolonged Grief-13-scale
Time frame: 6 and 13 months
PROMIS Depression (8 item scale)
Time frame: Baseline to 1, 6, and 12/13 months
PROMIS Anxiety (8 item scale)
Time frame: Baseline to 1, 6, and 12/13 months
Perceived Stress Scale (4 item)
Time frame: Baseline to 1, 6, and 12/13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41721750von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annika von Heymann, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
6 sites in 1 country: see every site and its status.
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.