Results Summary

What was the research about?

Every year, nearly 1 million patients in hospital intensive care units (ICUs) get life support from machines that help them breathe. When these patients are well enough to leave the hospital, they often need help to deal with depression or anxiety.

In this study, the research team compared how well two programs worked to help patients cope with depression or anxiety after being on a breathing machine in an ICU:

  • Coping-skills program that included weekly phone calls with patients and families to discuss how to cope with symptoms, plus online education materials
  • Educational program that included online materials about the cause and treatment of the patient’s illness

What were the results?

For most patients and their families, neither program helped improve symptoms of depression or anxiety. But, for patients with high levels of depression and anxiety, the coping-skills program helped improve depression or anxiety symptoms more than the educational program.

Who was in the study?

The study included 175 patients who had been on a breathing machine in a hospital ICU for at least two days. The study also included 86 of the patients’ family members, who were mostly spouses or parents. The average age of patients was 52.

What did the research team do?

The research team assigned patients to one of two groups by chance. In the first group, patients received 30-minute phone calls every week for six weeks. During the calls, a psychologist gave patients advice about how to manage symptoms and develop coping skills. Patients also had access to online materials. In the second group, patients received six informational videos and materials about their illness. Patients in the second group also had two calls with a member of the research team to ask questions about the study.

The team interviewed the patients and their families before assigning them to groups, and then three months and six months after the study started.

What were the limits of the study?

Many patients who joined the study became too ill or died before they could complete the study. As a result, the study may not have been able to detect some differences between the two programs. Future research could find out more about how the programs work for different groups of people.

How can people use the results?

Hospital ICUs could consider using a program to teach coping skills to patients who are very depressed or anxious at hospital discharge from the ICU.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer review process here.

In response to peer review, the PI made changes including

  • Providing more emphasis on 6-month outcomes to mirror the results posted at ClinicalTrials.gov
  • Clarifying that because the primary outcomes of the compared interventions did not differ significantly, the apparent differences in the secondary outcomes should be considered exploratory and subject to confirmatory research
  • Including a Supplement with additional information about patient and stakeholder engagement, more detailed analyses, and intervention details that did not fit into the main text

Conflict of Interest Disclosures

Project Information

Christopher Ethan Cox, MD, MPH
Duke University
$1,888,100
10.25302/9.2018.CER.195
Improving Psychological Distress Among Critical Illness Survivors and Their Informal Caregivers

Key Dates

December 2012
January 2017
2012
2017

Study Registration Information

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Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: April 11, 2024