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.
Professional Abstract
Objective
To compare a telephone- and web-based coping-skills training program with an educational program about critical illness to reduce anxiety and depression symptoms in patients discharged from the hospital following mechanical ventilation in the intensive care unit (ICU) and their family members
Study Design
Design Element | Description |
---|---|
Study Design | Randomized controlled trial |
Population | 175 patients who were discharged following mechanical ventilation in the ICU and 86 of their family members |
Interventions/ Comparators |
|
Outcomes |
Primary: summary score on the Hospital Anxiety and Depression Scale (HADS) Secondary: HADS anxiety and depression subscale scores, posttraumatic stress disorder (PTSD), quality of life, mental and physical health status, coping behaviors, self-efficacy |
Timeframe | 6-month follow-up for primary outcome |
In this randomized controlled clinical trial, the research team compared a telephone- and web-based coping-skills training program with an educational program that included web-based, video, and printed information about critical illness. The primary outcome was combined symptoms of depression and anxiety. Secondary outcomes were depression symptoms, anxiety symptoms, posttraumatic stress disorder (PTSD) symptoms, mental and physical health status, quality of life, positive coping behaviors, and self-efficacy in patients and their family members.
Patients and family members in the coping-skills training program received weekly 30-minute phone calls from a psychologist for six weeks to discuss coping skills for managing emotional distress and physical disabilities. They also received links to online materials with information about these coping skills. Patients and family members in the educational program received six informational videos, as well as print and web-based information about patients’ illnesses, a phone call with a researcher to review materials, and a follow-up call with a researcher to answer participants’ questions.
This study included 175 patients who were discharged from four hospitals’ ICUs after receiving mechanical ventilation for at least 48 hours. About 57% of patients were male, and 71% of patients were white. The mean patient age was 52. The study also included 86 family members, most of whom were spouses or parents.
The research team interviewed study participants three times: prior to randomization, three months after the start of the trial, and six months after the start of the trial.
Results
Overall, compared with the educational program, the coping-skills training program did not reduce symptoms of depression, anxiety, or PTSD for patients or their family members. Similarly, there were no significant differences in quality of life, physical health status, or mental health status. However, among patients who had high levels of depression and anxiety at baseline, those in the coping-skills training program had reduced psychological distress symptoms at six months compared with those in the educational program (p = 0.02).
Limitations
Almost 40% of the patients who consented to the study while in the hospital did not participate. The primary reason for lack of participation was persistent or worsening illness.
Conclusions and Relevance
Among the patients who received mechanical ventilation in the ICU and their family members, the coping-skills training program did no better than the educational program in reducing depression and anxiety symptoms. However, patients with high baseline levels of anxiety and depression had improved anxiety and depression after the coping-skills training program.
Future Research Needs
To help patients discharged from the ICU after mechanical ventilation and their family members, future research could consider ways to improve the delivery of therapies focused on coping skills to patients who have high levels of distress after they arrive home.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
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