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Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers

Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01983254
Enrollment
417
Registered
2013-11-13
Start date
2013-10-31
Completion date
2016-04-30
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Survivors, Informal Caregivers (Family and Friends)

Keywords

coping, acute respiratory failure, critical illness, depression, anxiety, post-traumatic stress, intensive care unit

Brief summary

Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We are trying to learn which is a better way to manage this distress: a telephone-based adaptive coping skills training program or an educational program.

Detailed description

Public Summary of Research Project Why is this important? Nearly 800,000 Americans receive mechanical ventilation for acute respiratory failure in the ICU each year. Afterward, over half of both patients and their family caregivers suffer from psychological distress (depression, anxiety, and post-traumatic stress \[PTSD\]) for over 1 year after discharge. Patients and families told us that they need help with their distress because it worsens their quality of life. More specifically, patients said that learning how to adapt (that is, how to cope) with the physical and emotional changes of critical illness would be helpful. In fact, most ICU survivors use coping skills infrequently, which worsens psychological distress. But patients also told us that they wanted more information about critical illness, recovery, and what to expect. A lack of information increases PTSD symptoms. However, there are few treatments for this distress that can overcome ICU survivors' physical disability, great distance from expert medical centers, and concerns about how much treatments would cost. Therefore, we developed two treatments to address coping and lack of information. What is the main goal? We aim to compare which of two treatments are more effective in reducing psychological distress and improving quality of life. One is a coping skills training (CST) program provided by telephone. The other is an education program about critical illness that is accessed primarily online. Also, we will determine if unique groups of people with special characteristics have especially good improvement-and if so, what personal factors explain this response. How will we know which treatment is better? We will determine which treatment is most helpful by comparing participants' levels of psychological distress and quality of life with surveys taken over 6 months. We'll also record patients' own descriptions of how the treatments impacted their daily lives. The study will take 3 years and would be performed at 5 medical centers across the US that treat patients with diverse backgrounds and illnesses. 200 ICU survivor-family member pairs will be randomly assigned (like a coin flip) to receive either the CST program or the education program. Treatments consist of 6 weekly telephone calls with a trained staff member, web-based modules, and handouts. How will this help others in the future? This research is important because it aims to improve long-term recovery for entire families by focusing on a devastating, common, yet inadequately addressed problem. These treatments were developed with the direct input of patients and families. These treatments represent a new direction in treating critical illness because they can be delivered inexpensively by phone, easily adapted to future technologies, overcome barriers to care common to ICU survivors, and shared easily by phone or computer with others in need across the world.

Interventions

6-session coping skills training program delivered by telephone w/ web augmentation

OTHEReducation program

web-based, ICU-specific education program

Sponsors

University of North Carolina, Chapel Hill
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
University of Washington
CollaboratorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient inclusion criteria: * age \>=18 and * mechanical ventilation for more than 48 consecutive hours Patient exclusions (pre-consent): * current significant cognitive impairment (\>=3 errors on the Callahan scale) or lacks decisional capacity * pre-existing significant cognitive impairment * residence at location other than home before hospital admission * need for a translator because of poor English fluency \[many study instruments are not validated in other languages\] * expected survival \<3 months * discharged to hospice (outpatient or inpatient) * not liberated from mechanical ventilation at discharge Additional patient

Exclusion criteria

(present post-consent but pre-randomization): * Patients will become ineligible if they become too ill to participate * they develop significant cognitive disability, exhibit suicidality, they do not return home within 2 months after hospital discharge, or die. Informal caregiver inclusion criteria: * age \>=18 years * person most likely to provide the most post-discharge care. Exclusions for caregivers are: * history of significant cognitive impairment * English fluency poor enough to require a medical translator Informal caregiver

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale Score3 & 6 months post-randomizationHospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well

Secondary

MeasureTime frameDescription
Impact of Events Scale-revised (IES-R) Score3 & 6 months post-randomizationThe IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = not at all, 1 = a little bit, 2 = moderately often, 3 = quite a bit, and 4 = extremely often. The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.

Other

MeasureTime frameDescription
Total Weeks at Home Post-randomizationover 6 months follow uphere reported as weeks (instead of days) not at home for simplicity

Countries

United States

Participant flow

Recruitment details

417 participants were enrolled (277 patients and 140 informal caregivers). 261 participants were randomized (175 patients and 86 caregivers).

Participants by arm

ArmCount
Coping Skills Training
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
125
Education Program
6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program
136
Total261

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath66
Overall StudyLost to Follow-up1716
Overall Studytoo ill118

Baseline characteristics

CharacteristicCoping Skills TrainingEducation ProgramTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants26 Participants46 Participants
Age, Categorical
Between 18 and 65 years
105 Participants110 Participants215 Participants
Age, Continuous
Caregivers
50.0 years
STANDARD_DEVIATION 14.9
52.9 years
STANDARD_DEVIATION 15.2
51.4 years
STANDARD_DEVIATION 15
Age, Continuous
Patients
49.7 years
STANDARD_DEVIATION 13.8
53.7 years
STANDARD_DEVIATION 13.5
51.7 years
STANDARD_DEVIATION 13.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants3 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
125 Participants133 Participants258 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
25 Participants25 Participants50 Participants
Race (NIH/OMB)
More than one race
1 Participants5 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
95 Participants102 Participants197 Participants
Region of Enrollment
United States
125 participants136 participants261 participants
Sex: Female, Male
Female
71 Participants73 Participants144 Participants
Sex: Female, Male
Male
54 Participants63 Participants117 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 1256 / 136
other
Total, other adverse events
0 / 1250 / 136
serious
Total, serious adverse events
0 / 1250 / 136

Outcome results

Primary

Hospital Anxiety and Depression Scale Score

Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well

Time frame: 3 & 6 months post-randomization

Population: Patients who completed the HADS scale at 3 \& 6 months post-randomization.

ArmMeasureGroupValue (MEAN)Dispersion
Coping Skills TrainingHospital Anxiety and Depression Scale Score3 months16.6 units on a scale (HADS summary score)Standard Error 0.9
Coping Skills TrainingHospital Anxiety and Depression Scale Score6 months15.6 units on a scale (HADS summary score)Standard Error 1
Education ProgramHospital Anxiety and Depression Scale Score3 months15.3 units on a scale (HADS summary score)Standard Error 0.9
Education ProgramHospital Anxiety and Depression Scale Score6 months15.9 units on a scale (HADS summary score)Standard Error 1
Secondary

Impact of Events Scale-revised (IES-R) Score

The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = not at all, 1 = a little bit, 2 = moderately often, 3 = quite a bit, and 4 = extremely often. The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.

Time frame: 3 & 6 months post-randomization

Population: Patients who completed the IES-R scale at 3 \& 6 months post-randomization.

ArmMeasureGroupValue (MEAN)Dispersion
Coping Skills TrainingImpact of Events Scale-revised (IES-R) Score3 months31.0 units on a scale (IES-R)Standard Error 2.6
Coping Skills TrainingImpact of Events Scale-revised (IES-R) Score6 months29.4 units on a scale (IES-R)Standard Error 2.9
Education ProgramImpact of Events Scale-revised (IES-R) Score3 months27.9 units on a scale (IES-R)Standard Error 2.6
Education ProgramImpact of Events Scale-revised (IES-R) Score6 months25.8 units on a scale (IES-R)Standard Error 2.9
Other Pre-specified

Total Weeks at Home Post-randomization

here reported as weeks (instead of days) not at home for simplicity

Time frame: over 6 months follow up

Population: patients

ArmMeasureValue (MEAN)Dispersion
Coping Skills TrainingTotal Weeks at Home Post-randomization1.3 weeks not at home during follow upStandard Deviation 3
Education ProgramTotal Weeks at Home Post-randomization1.6 weeks not at home during follow upStandard Deviation 3.5

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026