Illness, CriticalNCT03736954
ICU Doulas Providing Psychological Support
A study testing positive suggestion in people with Illness, Critical and Anxiety, run by Mayo Clinic at 1 site in United States.
Trial summary
Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Illness, Critical, Anxiety, Depression
- What is being tested?
- positive suggestion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 31 Dec 2021
- 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
- adults (age >18) admitted to the ICU requiring intubation or vasopressors and expected to stay >48 hours.
Who cannot join
- history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy;
- patients on comfort care;
- patients not expected to survive the hospital stay
- non-English speaking, deaf or mute
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study of ICU Doulas Providing Psychological Support Based on Positive Suggestions to Mitigate Psychological and Cognitive Sequelae of Critical Illness
Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback
- Conditions
- Illness, Critical, Anxiety, Depression, Post Traumatic Stress Disorder, Cognitive Impairment
- Being tested
- positive suggestion
- Medical subject headings
- Critical Illness, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive suggestionBehavioural
humanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants
| Study group | Role | What they receive |
|---|---|---|
| ICU doulas intervention | Experimental | specially trained ICU doulas will provide critically ill intubated patients with early psychological support on a daily basis Receives: Behavioral: positive suggestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of integration of trained doulas into the ICU
pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.
Measured: 6 months
Secondary outcomes (4)
Patient scores on Hospital Anxiety and Depression Scale
quantitative. Study patients will complete follow-up questionnaires measuring symptoms of anxiety and depression following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Measured: 6 months
Patient scores on Impact of Events Scale - Revised
quantitative. Study patients will complete follow-up questionnaires measuring symptoms of acute stress following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Measured: 6 months
Patient scores on Montreal Cognitive Assessment-blind
quantitative. Study patients will complete follow-up questionnaires measuring cognitive function following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Measured: 6 months
Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients
We will use an "interpretive description approach" to qualitative research, which creates an interpretive account of a clinical phenomenon for the purpose of informing clinical practice. We aim to understand the changes in experiences of critically ill patients, their family members, and providers through the interviews. This allows us to explore patient and key stakeholders' perspectives and to refine PSBPS based on the areas of highest priority, focusing on elements that are deemed by patients to be of highest acceptability. Following patient ICU discharge, interviews will be conducted on a one-on-one basis by the candidate or a trained qualitative interviewer who is not directly involved in the patient's clinical care; participants will be assured that interview transcripts will be confidential. Interviews will last approximately 15 minutes and will be conducted in person.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start12 Nov 2018
- Primary completion9 May 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Illness, CriticalStudies 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
- Model description
- pilot study
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT03736954
- Sponsor's protocol ID
- 17-008755
- Status last verified
- Feb 2022
- First submitted
- 14 Mar 2018
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karnatovskaia LV, Varga K, Niven AS, Schulte PJ, Mujic M, Gajic O, Bauer BA, Clark MM, Benzo RP, Philbrick KL. A pilot study of trained ICU doulas providing early psychological support to critically ill patients. Crit Care. 2021 Dec 20;25(1):446. doi: 10.1186/s13054-021-03856-3.
PubMed 34930440Karnatovskaia LV, Schultz JM, Niven AS, Steele AJ, Baker BA, Philbrick KL, Del Valle KT, Johnson KR, Gajic O, Varga K. System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. Crit Care Explor. 2021 Apr 26;3(4):e0403. doi: 10.1097/CCE.0000000000000403. eCollection 2021 Apr.
PubMed 33912833
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of ICU Doulas Providing Psychological Support Based on Positive Suggestions to Mitigate Psychological and Cognitive Sequelae of Critical Illness
- ClinicalTrials.gov ID
- NCT03736954
- Acronym / sponsor ID
- 17-008755
- Conditions
- Illness, Critical, Anxiety, Depression, Post Traumatic Stress Disorder, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Nov 2018 (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.
Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot study
| Arm | Type | Receives |
|---|---|---|
| ICU doulas intervention | Experimental | Behavioral: positive suggestionspecially trained ICU doulas will provide critically ill intubated patients with early psychological support on a daily basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults (age >18) admitted to the ICU requiring intubation or vasopressors and expected to stay >48 hours.
Key exclusion criteria (5 listed)
- history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy;
- patients on comfort care;
- patients not expected to survive the hospital stay
- non-English speaking, deaf or mute
- prisoners
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 |
|---|---|---|
| positive suggestionhumanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants | Behavioural | ICU doulas intervention |
Primary outcome
feasibility of integration of trained doulas into the ICU
Time frame: 6 months
pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.
4 secondary outcomes
Patient scores on Hospital Anxiety and Depression Scale
Time frame: 6 months
Patient scores on Impact of Events Scale - Revised
Time frame: 6 months
Patient scores on Montreal Cognitive Assessment-blind
Time frame: 6 months
Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients
Time frame: 6 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 8 Mar 2022.
- Background: PubMed 34930440Karnatovskaia LV, Varga K, Niven AS, Schulte PJ, Mujic M, Gajic O, Bauer BA, Clark MM, Benzo RP, Philbrick KL. A pilot study of trained ICU doulas providing early psychological support to critically ill patients. Crit Care. 2021 Dec 20;25(1):446. doi: 10.1186/s13054-021-03856-3.
- Background: PubMed 33912833Karnatovskaia LV, Schultz JM, Niven AS, Steele AJ, Baker BA, Philbrick KL, Del Valle KT, Johnson KR, Gajic O, Varga K. System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. Crit Care Explor. 2021 Apr 26;3(4):e0403. doi: 10.1097/CCE.0000000000000403. eCollection 2021 Apr.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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 positive suggestion in people with Illness, Critical and Anxiety, 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 8 Mar 2022. 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?
feasibility of integration of trained doulas into the ICU (time frame: 6 months). 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 NCT03736954, which also lists 2 linked publications.
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 8 Mar 2022.