Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
2 other identifiers
interventional
417
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedJanuary 21, 2020
January 1, 2020
2.3 years
November 1, 2013
February 17, 2017
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 & 6 months post-randomization
Secondary Outcomes (1)
Impact of Events Scale-revised (IES-R) Score
3 & 6 months post-randomization
Other Outcomes (1)
Total Weeks at Home Post-randomization
over 6 months follow up
Study Arms (2)
Coping skills training
EXPERIMENTAL6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
education program
ACTIVE COMPARATOR6 week access to a web-based, critical illness-specific education program
Interventions
6-session coping skills training program delivered by telephone w/ web augmentation
Eligibility Criteria
You may qualify if:
- age \>=18 and
- mechanical ventilation for more than 48 consecutive hours
- 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
You may not qualify if:
- 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.
- age \>=18 years
- person most likely to provide the most post-discharge care.
- history of significant cognitive impairment
- English fluency poor enough to require a medical translator
- no longer available
- become too ill to participate
- exhibit suicidality
- A total of 200 patient-caregiver dyads (total cohort = 400) are targeted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- University of North Carolina, Chapel Hillcollaborator
- University of Pittsburghcollaborator
- University of Washingtoncollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (4)
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (2)
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.
PMID: 22527082BACKGROUNDCox CE, Hough CL, Carson SS, White DB, Kahn JM, Olsen MK, Jones DM, Somers TJ, Kelleher SA, Porter LS. Effects of a Telephone- and Web-based Coping Skills Training Program Compared with an Education Program for Survivors of Critical Illness and Their Family Members. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):66-78. doi: 10.1164/rccm.201704-0720OC.
PMID: 28872898RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Cox, PI
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher E Cox, MD MPH
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 13, 2013
Study Start
October 1, 2013
Primary Completion
February 1, 2016
Study Completion
April 1, 2016
Last Updated
January 21, 2020
Results First Posted
April 4, 2017
Record last verified: 2020-01