Trial Outcomes & Findings for Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients (NCT NCT03276559)
NCT ID: NCT03276559
Last Updated: 2024-08-20
Results Overview
Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
COMPLETED
NA
63 participants
At baseline (T1) and in the week following the intervention (T2)
2024-08-20
Participant Flow
81 caregivers consented. 16 were not eligible (eligibility's determined by a brief screening assessment conducted after participants sign consent form). 2 were loss to follow-up prior to sending the T1 assessment. 63 participants completed the first assessment (T1). After T1 is completed, participants are randomized to study groups. 60 caregivers were randomized because 1 patient died (patients were not considered enrolled in the study), 1 patient was discharged, and 1 was loss to follow-up.
Participant milestones
| Measure |
Randomized Controlled Trial EMPOWER Arm
The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone.
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.
EMPOWER: EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
The usual care arm indicates regular ICU support for informal caregivers (i.e. social work, chaplaincy) as recorded in the patient's medical record, a general information packet for informal caregivers, and a site-specific resource list.
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the usual care within 3 months conducted in person and by phone.
Enhanced Usual Care: Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
Open Trial COVID-19 Phase Arm
The COVID-19 open trial phase arm did not include randomization or control arm. All participants received the EMPOWER intervention. Assessments will occur pre-intervention, immediately post-intervention, and then 1-month and 3-months from post-intervention assessment.
EMPOWER: EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
T1 Assessment
All participants that completed the first assessment (T1).
|
|---|---|---|---|---|
|
T1 Assessment
STARTED
|
0
|
0
|
0
|
63
|
|
T1 Assessment
COMPLETED
|
0
|
0
|
0
|
63
|
|
T1 Assessment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomization
STARTED
|
10
|
10
|
0
|
0
|
|
Randomization
COMPLETED
|
5
|
6
|
0
|
0
|
|
Randomization
NOT COMPLETED
|
5
|
4
|
0
|
0
|
|
EMPOWER Only
STARTED
|
0
|
0
|
23
|
0
|
|
EMPOWER Only
COMPLETED
|
0
|
0
|
14
|
0
|
|
EMPOWER Only
NOT COMPLETED
|
0
|
0
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
Baseline characteristics by cohort
| Measure |
Randomized Controlled Trial EMPOWER Arm
n=20 Participants
The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone.
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.
EMPOWER: EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
The usual care arm indicates regular ICU support for informal caregivers (i.e. social work, chaplaincy) as recorded in the patient's medical record, a general information packet for informal caregivers, and a site-specific resource list.
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the usual care within 3 months conducted in person and by phone.
Enhanced Usual Care: Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
Open Trial COVID-19 Phase Arm
n=23 Participants
The COVID-19 open trial phase arm did not include randomization or control arm. All participants received the EMPOWER intervention. Assessments will occur pre-intervention, immediately post-intervention, and then 1-month and 3-months from post-intervention assessment.
EMPOWER: EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
0 Participants
n=17 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
0 Participants
n=23 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
0 Participants
n=58 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=18 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
13 Participants
n=17 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
23 Participants
n=23 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
53 Participants
n=58 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=18 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
4 Participants
n=17 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
0 Participants
n=23 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
5 Participants
n=58 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
|
Age, Continuous
|
43.635 years
STANDARD_DEVIATION 11.313 • n=18 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
51.413 years
STANDARD_DEVIATION 15.705 • n=17 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
42.091 years
STANDARD_DEVIATION 9.282 • n=23 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
45.303 years
STANDARD_DEVIATION 12.523 • n=58 Participants • 2 participants in the Randomized Controlled Trial EMPOWER Arm have missing age data, which is why the number analyzed is 18 participants instead of 20 participants.
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
13 Participants
n=17 Participants
|
17 Participants
n=23 Participants
|
45 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
4 Participants
n=17 Participants
|
6 Participants
n=23 Participants
|
15 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants
|
4 Participants
n=17 Participants
|
7 Participants
n=23 Participants
|
16 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=20 Participants
|
10 Participants
n=17 Participants
|
15 Participants
n=23 Participants
|
39 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
3 Participants
n=17 Participants
|
1 Participants
n=23 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=23 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
2 Participants
n=17 Participants
|
6 Participants
n=23 Participants
|
11 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=20 Participants
|
9 Participants
n=17 Participants
|
7 Participants
n=23 Participants
|
28 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=17 Participants
|
9 Participants
n=23 Participants
|
13 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
17 Participants
n=17 Participants
|
23 Participants
n=23 Participants
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: At baseline (T1) and in the week following the intervention (T2)Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
|---|---|---|
|
Change in Peritraumatic Distress Inventory
Pre-Intervention Time 1
|
14.6 score on a scale
Interval 12.4 to 16.8
|
14.2 score on a scale
Interval 10.2 to 18.3
|
|
Change in Peritraumatic Distress Inventory
Post-Intervention Time 2
|
13.0 score on a scale
Interval 9.9 to 16.0
|
14.4 score on a scale
Interval 9.2 to 19.5
|
SECONDARY outcome
Timeframe: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4)..The PG-12 consists of 12 items and total score can range from 0 to 57. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
|---|---|---|
|
Change in Anticipatory Grief
Post-Intervention Time 2
|
25.7 score on a scale
Interval 22.8 to 28.6
|
25.4 score on a scale
Interval 20.9 to 29.0
|
|
Change in Anticipatory Grief
Pre-Intervention Time 1
|
29.1 score on a scale
Interval 26.4 to 31.8
|
24.8 score on a scale
Interval 20.5 to 29.2
|
|
Change in Anticipatory Grief
One Month Time 3
|
24.2 score on a scale
Interval 22.1 to 26.4
|
26.5 score on a scale
Interval 21.9 to 31.2
|
|
Change in Anticipatory Grief
Three Months Time 4
|
20.3 score on a scale
Interval 17.8 to 22.9
|
23.0 score on a scale
Interval 19.3 to 26.7
|
SECONDARY outcome
Timeframe: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4). The BEAQ consists of 15 items and total score can range from 15 to 90. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
|---|---|---|
|
Change in Experiential Avoidance
Pre-Intervention (T1)
|
44.7 score on a scale
Interval 40.3 to 49.1
|
44.5 score on a scale
Interval 40.2 to 48.9
|
|
Change in Experiential Avoidance
Post-Intervention (T2)
|
42.2 score on a scale
Interval 39.2 to 46.3
|
40.7 score on a scale
Interval 34.7 to 46.7
|
|
Change in Experiential Avoidance
One Month Time (T3)
|
43.3 score on a scale
Interval 39.0 to 47.7
|
48.2 score on a scale
Interval 43.2 to 53.3
|
|
Change in Experiential Avoidance
Three Months Time (T4)
|
43.2 score on a scale
Interval 39.0 to 47.4
|
48.2 score on a scale
Interval 41.1 to 55.3
|
SECONDARY outcome
Timeframe: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4). The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
|---|---|---|
|
Change in Post-Traumatic Stress Disorder
One Month Time (T3)
|
24.3 score on a scale
Interval 18.3 to 30.2
|
29.8 score on a scale
Interval 21.0 to 38.7
|
|
Change in Post-Traumatic Stress Disorder
Pre-Intervention (T1)
|
29.9 score on a scale
Interval 25.2 to 34.5
|
24.6 score on a scale
Interval 15.5 to 33.8
|
|
Change in Post-Traumatic Stress Disorder
Post-Intervention (T2)
|
23.1 score on a scale
Interval 17.7 to 28.5
|
25.8 score on a scale
Interval 16.7 to 34.9
|
|
Change in Post-Traumatic Stress Disorder
Three Months Time (T4)
|
16.0 score on a scale
Interval 12.1 to 19.8
|
22.1 score on a scale
Interval 14.5 to 29.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).The STAI-Y state scale consists of 20 items and total score can range from 20 to 80. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
|---|---|---|
|
Change in Anxiety
Three Month Time (T4)
|
35.2 score on a scale
Interval 32.3 to 38.1
|
32.2 score on a scale
Interval 28.1 to 36.4
|
|
Change in Anxiety
Pre-Intervention Time 1
|
40.6 score on a scale
Interval 38.3 to 42.9
|
38.8 score on a scale
Interval 35.4 to 42.3
|
|
Change in Anxiety
Post-Intervention Time 2
|
37.0 score on a scale
Interval 34.5 to 39.6
|
37.4 score on a scale
Interval 33.4 to 41.3
|
|
Change in Anxiety
One Month Time (T3)
|
36.2 score on a scale
Interval 32.9 to 38.5
|
35.4 score on a scale
Interval 32.1 to 38.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline (T1), one month and three months from baseline (T3 and T4).Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Symptoms of depression, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at baseline (T1), one month and three months from baseline (T3 and T4).. The PHQ-9 consists of 9 items and total score can range from 0 to 27. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
|
Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
|
|---|---|---|
|
Change in Depression
Pre-Intervention Time 1
|
8.9 score on a scale
Interval 6.7 to 10.4
|
6.8 score on a scale
Interval 4.3 to 9.2
|
|
Change in Depression
Three Months Time 4
|
7.6 score on a scale
Interval 5.6 to 9.6
|
8.2 score on a scale
Interval 5.4 to 11.1
|
|
Change in Depression
One Month Time 3
|
6.9 score on a scale
Interval 5.9 to 12.5
|
9.2 score on a scale
Interval 5.9 to 12.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).Population: As pre-specified in the analysis plan, "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" are combined because there were no procedural differences for subjects in both groups, besides the "Randomized Controlled Trial EMPOWER Arm" subjects were randomized to that group instead of the usual care group. Subjects in both the "Randomized Controlled Trial EMPOWER Arm" and "Open Trial COVID-19 Phase Arm" received the EMPOWER intervention and were thus analyzed together.
Decision regret, as measured by the Decision Regret Scale, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4). The decision regret scale is a five-item measure, on a scale from 1-5. Total scores will be added up, and higher scores represent greater decision regret. Lower scores represent less decision regret. The maximum score is 25 and the minimum score is 5.
Outcome measures
| Measure |
Randomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm Combined
n=43 Participants
EMPOWER is a manualized cognitive-behavioral, acceptance-based intervention delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psycho-education, and imaginal dialogue with the patient and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
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Randomized Controlled Trial Enhanced Usual Care Arm
n=17 Participants
Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
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Change in Decision Regret
Pre-Intervention Time 1
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17.2 score on a scale
Interval 10.3 to 24.1
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19.4 score on a scale
Interval 8.0 to 30.8
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Change in Decision Regret
Post-Intervention Time 2
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20.5 score on a scale
Interval 15.3 to 25.6
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15.3 score on a scale
Interval 5.7 to 24.9
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Change in Decision Regret
One Month Time 3
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24.3 score on a scale
Interval 19.1 to 29.5
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18.5 score on a scale
Interval 8.7 to 28.4
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Change in Decision Regret
Three Months Time 4
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19.1 score on a scale
Interval 14.2 to 23.9
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22.6 score on a scale
Interval 13.7 to 31.6
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Adverse Events
Randomized Controlled Trial EMPOWER Arm
Randomized Controlled Trial Enhanced Usual Care Arm
Open Trial COVID-19 Phase Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place