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Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045210
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Lioudmila Karnatovskaia, Mayo Clinic

Brief Summary:
The Researchers are trying to evaluate efficacy of a psychotherapeutic approach that can be applied to those who are critically ill. The daily approach in the Intensive Care Unit (ICU) is designed to provide patients with psychological support, reassurance, and explanations of where they are and what is happening to them.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Psychological Support Based on Positive Suggestions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a three arm single-center, prospective, randomized, controlled trial comparing the effect of PSBPS vs. no PSBPS on psychological and clinical outcomes in the critically ill population. PSBPS will be administered by trained doulas or a trained psychiatrist to eligible patients
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Evaluate Efficacy of Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive Function
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Intervention
Experimental: Doula Other: Psychological Support Based on Positive Suggestions
Eligible patients will be randomized at the earliest possible time after meeting inclusion criteria. Patients will be randomized 1:1:1 to intervention by either doulas or a psychiatrist or a non-intervention arms stratified by ICU location. Both intervention and controls will receive standard medical care at the discretion of the ICU team. The intervention arm will receive PSBPS as soon as feasible and continue on a daily basis. Doulas/psychiatrist will also liaise with family, the team, and with the nursing staff. Both intervention and standard of care arms will complete follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 6 months follow up by phone. All the patients randomized to the intervention arm will receive the same intervention.

Experimental: Psychologist Other: Psychological Support Based on Positive Suggestions
Eligible patients will be randomized at the earliest possible time after meeting inclusion criteria. Patients will be randomized 1:1:1 to intervention by either doulas or a psychiatrist or a non-intervention arms stratified by ICU location. Both intervention and controls will receive standard medical care at the discretion of the ICU team. The intervention arm will receive PSBPS as soon as feasible and continue on a daily basis. Doulas/psychiatrist will also liaise with family, the team, and with the nursing staff. Both intervention and standard of care arms will complete follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 6 months follow up by phone. All the patients randomized to the intervention arm will receive the same intervention.




Primary Outcome Measures :
  1. minimal important change in hospital anxiety and depression scale - Anxiety [ Time Frame: within 96 hours after ICU discharge and 6 months after hospital discharge ]
    This outcome will be evaluated using Hospital Anxiety and Depression Scale (HADS). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained from the control group and the two intervention groups within 96 hours after ICU discharge and at 6 months follow up


Secondary Outcome Measures :
  1. minimal important change in hospital anxiety and depression scale-Depression [ Time Frame: within 96 hours after ICU discharge and 6 months after hospital discharge ]
    This outcome will be evaluated using Hospital Anxiety and Depression Scale (HADS). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained from the control group and the two intervention groups within 96 hours after ICU discharge and at 6 months follow up


Other Outcome Measures:
  1. minimal important change in Impact of Event Scale-Revised [ Time Frame: within 96 hours after ICU discharge and 6 months after hospital discharge ]
    This outcome will be evaluated using Impact of Event Scale-Revised. The total scores range is 0-4. A higher score indicates worse symptoms of post traumatic stress. Comparison will be done between the score obtained from the control group and the two intervention groups within 96 hours after ICU discharge and at 6 months follow up

  2. statistically significant improvement in MoCA-blind [ Time Frame: within 96 hours after ICU discharge and 6 months after hospital discharge ]
    This outcome will be evaluated using Montreal cognitive assessment-blind (MoCA-blind). The total scores range is 0-22. A higher score indicates better cognitive function. Comparison will be done between the score obtained from the control group and the two intervention groups within 96 hours after ICU discharge and at 6 months follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Critically ill adult patients requiring vasopressor support or mechanical ventilation
  • Willing patient's family member
  • Adults (age >18) admitted to the ICU and expected to stay >48 hours.

Exclusion Criteria:

  • history of dementia
  • intellectual disability
  • 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.

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): NCT04045210


Contacts
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Contact: ACRU 866-265-9263 mailto:Karnatovskaia.Lioudmila@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Additional Information:
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Responsible Party: Lioudmila Karnatovskaia, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04045210    
Other Study ID Numbers: 19-004660
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019

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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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Critical Illness
Disease Attributes
Pathologic Processes