PICSNCT02739022
Feasibility Trial of the Early Psychological Support for the Critically Ill
A study testing Early Psychological Support for the Critically Ill (EPSCI) in people with PICS, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- PICS
- What is being tested?
- Early Psychological Support for the Critically Ill (EPSCI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jun 2017
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -mechanically ventilated patients receiving vasopressors
Who cannot join
- history of dementia
- mental retardation
- suicide attempt
- psychotic disorders such as schizophrenia
- patients on comfort care non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI)
- Conditions
- PICS
- Being tested
- Early Psychological Support for the Critically Ill (EPSCI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Psychological Support for the Critically Ill (EPSCI)Behavioural
early psychological support based on positive therapeutic suggestion
| Study group | Role | What they receive |
|---|---|---|
| Early Psychological Support for the Critically Ill (EPSCI) | Experimental | patients will receive EPSCI in parallel with medical treatment Receives: Behavioral: Early Psychological Support for the Critically Ill (EPSCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Events Scale-Revised (IES-R) score
rate of PTSD following ICU stay
Measured: 1 year
Secondary outcomes (3)
feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)
how much time therapy takes, how many interruptions, feedback from staff/family/patient
Measured: 1 year
Hospital Anxiety and Depression Scale (HADS) score
rate of anxiety and depression following intensive care unit (ICU) stay
Measured: 1 year
Montreal Cognitive Assessment-Blind (MoCA-blind) score
rate of cognitive dysfunction following ICU stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017
- Study completionJun 2017
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 PICSStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lioudmila Karnatovskaia, Mayo Clinic
- Investigators
- Lioudmila V Karnatovskaia, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739022
- Sponsor's protocol ID
- 16-000145
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2016
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tan Y, Gajic O, Schulte PJ, Clark MM, Philbrick KL, Karnatovskaia LV. Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. Int J Clin Exp Hypn. 2020 Oct-Dec;68(4):419-432. doi: 10.1080/00207144.2020.1795663. Epub 2020 Jul 30.
PubMed 32730136
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of the Early Psychological Support for the Critically Ill
- ClinicalTrials.gov ID
- NCT02739022
- Acronym / sponsor ID
- 16-000145
- Conditions
- PICS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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.
This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Psychological Support for the Critically Ill (EPSCI) | Experimental | Behavioral: Early Psychological Support for the Critically Ill (EPSCI)patients will receive EPSCI in parallel with medical treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -mechanically ventilated patients receiving vasopressors
Key exclusion criteria (5 listed)
- history of dementia
- mental retardation
- suicide attempt
- psychotic disorders such as schizophrenia
- patients on comfort care non-English speaking.
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 |
|---|---|---|
| Early Psychological Support for the Critically Ill (EPSCI)early psychological support based on positive therapeutic suggestion | Behavioural | Early Psychological Support for the Critically Ill (EPSCI) |
Primary outcome
Impact of Events Scale-Revised (IES-R) score
Time frame: 1 year
rate of PTSD following ICU stay
3 secondary outcomes
feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)
Time frame: 1 year
Hospital Anxiety and Depression Scale (HADS) score
Time frame: 1 year
Montreal Cognitive Assessment-Blind (MoCA-blind) score
Time frame: 1 year
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 1 Mar 2023.
- Background: PubMed 32730136Tan Y, Gajic O, Schulte PJ, Clark MM, Philbrick KL, Karnatovskaia LV. Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. Int J Clin Exp Hypn. 2020 Oct-Dec;68(4):419-432. doi: 10.1080/00207144.2020.1795663. Epub 2020 Jul 30.
- 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.
Lioudmila V Karnatovskaia principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Psychological Support for the Critically Ill (EPSCI) in people with PICS, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 5 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Impact of Events Scale-Revised (IES-R) score (time frame: 1 year). 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 NCT02739022, 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 1 Mar 2023.