NCT01983254|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · PCORI PFA 195
interventional
417
1 country
4
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
April 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 2013
Actual (reported)November 13, 2013
Actual (reported)February 2016
Actual (reported)April 2016
Actual (reported)April 4, 2017
Actual (reported)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
Impact of Events Scale-revised (IES-R) Score
3 & 6 months post-randomization
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
6 week access to a web-based, critical illness-specific education program
6-session coping skills training program delivered by telephone w/ web augmentation
web-based, ICU-specific education program
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
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.
Cox 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.
Christopher E Cox, MD MPH
Duke University
417 participants (actual enrollment reported by the registry).
First Submitted
November 1, 2013
First Posted
November 13, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Total Weeks at Home Post-randomization
over 6 months follow up
Contact the study team to confirm eligibility.
Primary Completion
February 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
January 21, 2020
Results First Posted
April 4, 2017
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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