Trial Outcomes & Findings for Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive Function (NCT NCT04045210)

Last Updated: 2026-08-21

Results Overview

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 intervention group within 96 hours after ICU discharge and at 6 months follow up

Recruitment status

COMPLETED

Study phase

Target enrollment

274 participants

Primary outcome timeframe

within 96 hours after ICU discharge and 6 months after hospital discharge

Results posted on

2026-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	No Intervention Group of patients that received standard medical care without psychological intervention	Doula Psychological Support Based on Positive Suggestions: Eligible patients were randomized at the earliest possible time after meeting inclusion criteria. Patients were randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls received standard medical care at the discretion of the ICU team. The intervention arm received PSBPS as soon as feasible and continued on a daily basis. Doulas also liaised with family, the team, and with the nursing staff. Both intervention and standard of care arms completed follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone.
Overall Study STARTED	114	160
Overall Study COMPLETED	56	85
Overall Study NOT COMPLETED	58	75

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Intervention n=56 Participants group that received no intervention	Doula n=85 Participants Psychological Support Based on Positive Suggestions: Eligible patients were randomized at the earliest possible time after meeting inclusion criteria. Patients were randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls received standard medical care at the discretion of the ICU team. The intervention arm received PSBPS as soon as feasible and continued on a daily basis. Doulas also liaised with family, the team, and with the nursing staff. Both intervention and standard of care arms completed follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone.	Total n=141 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	41 Participants n=109 Participants	70 Participants n=133 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	44 Participants n=109 Participants	71 Participants n=133 Participants
Age, Continuous	64.5 years n=5 Participants	67 years n=109 Participants	66 years n=133 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	42 Participants n=109 Participants	74 Participants n=133 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	43 Participants n=109 Participants	67 Participants n=133 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=109 Participants	1 Participants n=133 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	80 Participants n=109 Participants	131 Participants n=133 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=109 Participants	9 Participants n=133 Participants
Region of Enrollment United States	56 Participants n=5 Participants	85 Participants n=109 Participants	141 Participants n=133 Participants

PRIMARY outcome

Timeframe: within 96 hours after ICU discharge and 6 months after hospital discharge

Outcome measures

Outcome measures
Measure	No Intervention n=56 Participants Group of patients that received standard medical care without psychological intervention	Doula n=85 Participants Psychological Support Based on Positive Suggestions: Eligible patients were randomized at the earliest possible time after meeting inclusion criteria. Patients were randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls received standard medical care at the discretion of the ICU team. The intervention arm received PSBPS as soon as feasible and continued on a daily basis. Doulas also liaised with family, the team, and with the nursing staff. Both intervention and standard of care arms completed follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone.
Hospital Anxiety and Depression Scale - Anxiety baseline	5.5 units on a scale Interval 3.0 to 8.0	5 units on a scale Interval 3.0 to 8.0
Hospital Anxiety and Depression Scale - Anxiety 6 months	3 units on a scale Interval 1.0 to 5.0	2 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: within 96 hours after ICU discharge and 6 months after hospital discharge

Outcome measures

Outcome measures
Measure	No Intervention n=56 Participants Group of patients that received standard medical care without psychological intervention	Doula n=85 Participants Psychological Support Based on Positive Suggestions: Eligible patients were randomized at the earliest possible time after meeting inclusion criteria. Patients were randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls received standard medical care at the discretion of the ICU team. The intervention arm received PSBPS as soon as feasible and continued on a daily basis. Doulas also liaised with family, the team, and with the nursing staff. Both intervention and standard of care arms completed follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone.
Hospital Anxiety and Depression Scale-Depression baseline	6.5 units on a scale Interval 3.0 to 8.0	6 units on a scale Interval 3.0 to 9.0
Hospital Anxiety and Depression Scale-Depression 6 months	3 units on a scale Interval 2.0 to 5.0	2 units on a scale Interval 1.0 to 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 intervention group within 96 hours after ICU discharge and at 6 months follow up

Outcome measures

Outcome measures
Measure	No Intervention n=56 Participants Group of patients that received standard medical care without psychological intervention	Doula n=85 Participants Psychological Support Based on Positive Suggestions: Eligible patients were randomized at the earliest possible time after meeting inclusion criteria. Patients were randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls received standard medical care at the discretion of the ICU team. The intervention arm received PSBPS as soon as feasible and continued on a daily basis. Doulas also liaised with family, the team, and with the nursing staff. Both intervention and standard of care arms completed follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone.
Impact of Event Scale-Revised intrusion, baseline	0.4 units on a scale Interval 0.2 to 1.0	1 units on a scale Interval 0.1 to 1.0
Impact of Event Scale-Revised avoidance, baseline	0.1 units on a scale Interval 0.0 to 0.8	0 units on a scale Interval 0.0 to 0.3
Impact of Event Scale-Revised hyperarousal, baseline	0.5 units on a scale Interval 0.1 to 1.0	0.5 units on a scale Interval 0.1 to 1.0
Impact of Event Scale-Revised intrusion, 6 months	0.2 units on a scale Interval 0.0 to 1.0	0.3 units on a scale Interval 0.0 to 1.0
Impact of Event Scale-Revised avoidance, 6 months	0 units on a scale Interval 0.0 to 0.3	0 units on a scale Interval 0.0 to 1.0
Impact of Event Scale-Revised hyperarousal, 6 months	0.1 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 intervention group within 96 hours after ICU discharge and at 6 months follow up

Outcome measures

Outcome measures
Measure	No Intervention n=56 Participants Group of patients that received standard medical care without psychological intervention	Doula n=85 Participants Psychological Support Based on Positive Suggestions: Eligible patients were randomized at the earliest possible time after meeting inclusion criteria. Patients were randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls received standard medical care at the discretion of the ICU team. The intervention arm received PSBPS as soon as feasible and continued on a daily basis. Doulas also liaised with family, the team, and with the nursing staff. Both intervention and standard of care arms completed follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone.
MoCA-blind baseline	19 units on a scale Interval 17.0 to 20.0	18.5 units on a scale Interval 16.0 to 21.0
MoCA-blind 6 months	19 units on a scale Interval 17.0 to 21.0	20.5 units on a scale Interval 18.0 to 21.0

Adverse Events

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 34 deaths

Doula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 26 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lioudmila Karnatovskaia

Mayo Clinic

Phone: 507-284-3107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place