- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07812376
Effectiveness of Stress Management Training in Reducing Caregiver Burden and Perceived Stress in ICU Families
Effectiveness of a Stress Management Training Program in Reducing Caregiver Burden and Perceived Stress Among Families of Long-Stay ICU Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Admission to intensive care unit (ICU) is a very stressful event to the patient and his family members. Family caregivers of critically ill patients are confronted with constant uncertainty, fear of negative outcomes of care, unfamiliar environments, and a minimal participation in care, which makes them extremely vulnerable to developing psychological distress (Checa-Checa et al., 2025). This distress is often made worse when going through long serving time in ICU, especially when the patients are not able to communicate and be taken part in the decision-making process.
Family caregivers play a central role during the ICU hospitalization in terms of offering emotional support, attending the decision-making process, and offering a constant presence at the bedside. These responsibilities are often associated with neglect of the physical as well as psychological requirements of the caregivers. Evidence from hospital and critical care settings suggests that caregivers are exposed to high levels of stress and of emotional exhaustion, sleep disturbances and disruption to daily functioning (Abuatiq et al., 2020; McIlvennan et al., 2021). Over time these stressors may yield caregiver burden (a multidimensional phenomenon which may involve physical, emotional, social and psychological strains).
High levels of caregiver burden and perceived stress have been documented among multiple different populations of caregivers, including caregivers of patients with chronic and life-threatening conditions. Studies involving either family caregivers of patients undergoing hemodialysis, living with heart failure or recovering from stroke all report moderate to severe caregiver burden with high levels of perceived stress and negative emotions outcomes (Shaykh et al., 2023; Khouban-Shargh et al., 2024; Liu et al., 2025). These findings have a very relevant application in ICU, where the level of care, uncertainty about prognosis and very long stay cause further jeopardy among caregivers.
Perceived stress represents people's appreciation of situations as unpredictable, uncontrollable, and overwhelming. Among caregivers in the family setting, the high perceived stress levels have been linked to poor preparedness for caregiving positions, emotional stress, and lessened ability to cope (McIlvennan et al., 2021). Stressors like awaiting results of test results, fearing patient deterioration, sleep deprivation, monetary concerns, and lack of information access are common in ICU and hospital settings (Abuatiq et al, 2020; Krampe et al, 2021) according to caregivers.
Stress management interventions attempt to increase adaptive coping by increasing the ability to manage stress through better awareness of stress, the way we think about things, the way we manage emotions, and how well we are able to solve problems. Evidence from caring populations suggest that the implementation of structured stress management training programs was able to lower the burden on caregivers and perceived stress and also increase psychological well-being (Shaykh et al., 2023; Liu et al., 2025). In the critical care, interventions led by nurses and psychosocial healthcare have been linked to lessened psychological distress and better emotional outcomes among family members (Checa-Checa et al., 2025; Watland et al., 2025). However, many of the ICU interventions focus mainly on information provision and decision-making support, and may not place much emphasis on structured stress management training.
Despite the growing recognition of family-centered care within ICUs, a discrepancy exists with respect to the number of potential interventional research based specifically on issues of burden and perceived stress to family members of long-stay ICU patients. Evaluation of the effectiveness of a structured stress management training program in this population is, therefore, warranted in order to support the well-being of carers and to improve holistic and family-centred nursing care.
Aim of the Study To assess the effectiveness of a stress management training program in lowering caregiver burden, and perceived stress in family members of patients admitted to the ICU for over 10 days.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older.
- Identified as the primary caregiver or main family companion of a patient admitted to the ICU.
- The patient has had an ICU stay of more than 10 consecutive days.
- Able to communicate verbally and complete the study questionnaires.
- Have access to a smartphone, tablet, computer, or other digital device with internet access to participate in the training sessions.
- Willing and able to provide written informed consent to participate in the study
Exclusion Criteria:
- A history of a psychiatric disorder that substantially impairs their ability to understand the study procedures, communicate effectively, or complete the study questionnaires reliably.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interventional group
Stress Management Training Program
|
structured program of stress management training, including:
|
|
No Intervention: control group
no interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Score
Time Frame: 6 weeks
|
Perceived stress will be assessed using the 14-item Perceived Stress Scale (PSS-14).
The PSS assesses the level of perceived stress experienced over the previous month.
The PSS is available in three versions, including the PSS-14.
Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often).
After reverse-scoring the positively worded items, the item scores are summed to produce a total score ranging from 0 to 56.
Higher total scores indicate greater perceived stress.
The unit of measure is the total PSS-14 score (0-56).
|
6 weeks
|
|
Caregiver Burden as Measured by the 12-Item Zarit Burden Interview (ZBI-12)
Time Frame: 6 weeks
|
Caregiver burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12).
The ZBI-12 consists of 12 items rated on a 5-point Likert scale from 0 (never) to 4 (nearly always), with a total score ranging from 0 to 48.
Higher total scores indicate greater perceived caregiver burden.
The unit of measure is the total ZBI-12 score (0-48).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Abuatiq A, Brown R, Wolles B, Randall R. Perceptions of Stress: Patient and Caregiver Experiences With Stressors During Hospitalization. Clin J Oncol Nurs. 2020 Feb 1;24(1):51-57. doi: 10.1188/20.CJON.51-57.
- Nakhla AM, Latif A. Response of rat brain to calcitonin alteration. Brain Res. 1982 Apr 29;238(2):489-93. doi: 10.1016/0006-8993(82)90129-9.
- Khouban-Shargh R, Mirhosseini S, Ghasempour S, Basirinezhad MH, Abbasi A. Stress management training program to address caregiver burden and perceived stress among family caregivers of patients undergoing hemodialysis: a randomized controlled trial study. BMC Nephrol. 2024 Oct 14;25(1):350. doi: 10.1186/s12882-024-03795-5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60/5/2025/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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