Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01983254
• Collaborator: University of North Carolina, Chapel Hill (Other), University of Pittsburgh (Other), University of Washington (Other), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 417
• Locations: 4
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 104.3
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit Survivors; Informal Caregivers (Family and Friends)	Behavioral: coping skills training; Other: education program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 417 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coping skills training 6 sessions of weekly telephone-based coping skills training delivered by trained interventionist	Behavioral: coping skills training; 6-session coping skills training program delivered by telephone w/ web augmentation
Active Comparator: education program 6 week access to a web-based, critical illness-specific education program	Other: education program; web-based, ICU-specific education program

Outcome Measures

Primary Outcome Measures

1. Hospital Anxiety and Depression Scale Score [3 & 6 months post-randomization]

   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

Secondary Outcome Measures

1. Impact of Events Scale-revised (IES-R) Score [3 & 6 months post-randomization]

   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.

Other Outcome Measures

1. Total Weeks at Home Post-randomization [over 6 months follow up]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 exclusion criteria present after consent but before randomization:

• no longer available

• become too ill to participate

• exhibit suicidality

A total of 200 patient-caregiver dyads (total cohort = 400) are targeted

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina	Chapel Hill	North Carolina	United States	27599
2	Duke University	Durham	North Carolina	United States	27710
3	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
4	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Christopher E Cox, MD MPH, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cox CE, Porter LS, Hough CL, White DB, Kahn JM, Carson SS, Tulsky JA, Keefe FJ. Development and preliminary evaluation of a telephone-based coping skills training intervention for survivors of acute lung injury and their informal caregivers. Intensive Care Med. 2012 Aug;38(8):1289-97. doi: 10.1007/s00134-012-2567-3. Epub 2012 Apr 18.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01983254
• Other Study ID Numbers: Pro00043171; PCORI PFA 195
• First Posted: Nov 13, 2013
• Last Update Posted: Jan 21, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Duke University: coping; acute respiratory failure; critical illness; depression; anxiety; post-traumatic stress; intensive care unit
• Additional relevant MeSH terms: Critical Illness

Study Results

Participant Flow

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

Arm/Group Title	Coping Skills Training	Education Program
Arm/Group Description	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	6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program
Period Title: Overall Study
STARTED	125	136
Interview 1	125	136
Interview 2	95	110
Interview 3	91	106
COMPLETED	91	106
NOT COMPLETED	34	30

Baseline Characteristics

Arm/Group Title	Coping Skills Training	Education Program	Total
Arm/Group Description	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	6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program	Total of all reporting groups
Overall Participants	125	136	261
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	105 84%	110 80.9%	215 82.4%
>=65 years	20 16%	26 19.1%	46 17.6%
Age (years) [Mean (Standard Deviation) ]
Patients	49.7 (13.8)	53.7 (13.5)	51.7 (13.8)
Caregivers	50.0 (14.9)	52.9 (15.2)	51.4 (15.0)
Sex: Female, Male (Count of Participants)
Female	71 56.8%	73 53.7%	144 55.2%
Male	54 43.2%	63 46.3%	117 44.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	3 2.2%	3 1.1%
Not Hispanic or Latino	125 100%	133 97.8%	258 98.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	3 2.2%	3 1.1%
Asian	2 1.6%	0 0%	2 0.8%
Native Hawaiian or Other Pacific Islander	1 0.8%	0 0%	1 0.4%
Black or African American	25 20%	25 18.4%	50 19.2%
White	95 76%	102 75%	197 75.5%
More than one race	1 0.8%	5 3.7%	6 2.3%
Unknown or Not Reported	1 0.8%	1 0.7%	2 0.8%
Region of Enrollment (participants) [Number]
United States	125 100%	136 100%	261 100%

Outcome Measures

1. Primary Outcome

Title	Hospital Anxiety and Depression Scale Score
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coping Skills Training	Education Program
Arm/Group Description	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	6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program
Measure Participants	65	71
3 months	16.6 (0.9)	15.3 (0.9)
6 months	15.6 (1.0)	15.9 (1.0)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coping Skills Training	Education Program
Arm/Group Description	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	6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program
Measure Participants	65	71
3 months	31.0 (2.6)	27.9 (2.6)
6 months	29.4 (2.9)	25.8 (2.9)

3. Other Pre-specified Outcome

Title	Total Weeks at Home Post-randomization
Description	here reported as weeks (instead of days) not at home for simplicity
Time Frame	over 6 months follow up

Outcome Measure Data

Analysis Population Description

patients

Arm/Group Title	Coping Skills Training	Education Program
Arm/Group Description	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	6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program
Measure Participants	69	75
Measure weeks	24	24
Mean (Standard Deviation) [weeks not at home during follow up]	1.3 (3.0)	1.6 (3.5)

Adverse Events

Arm/Group Title	Coping Skills Training		Education Program
Arm/Group Description	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		6 week access to a web-based, critical illness-specific education program education program: web-based, ICU-specific education program
All Cause Mortality
	Coping Skills Training		Education Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/125 (4.8%)		6/136 (4.4%)
Serious Adverse Events
	Coping Skills Training		Education Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/136 (0%)
Other (Not Including Serious) Adverse Events
	Coping Skills Training		Education Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/136 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.