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Intensive Care Unit SyndromeNCT07812376

Effectiveness of Stress Management Training in Reducing Caregiver Burden and Perceived Stress in ICU Families

A study testing Stress Management Training Program in people with Intensive Care Unit Syndrome and Critical Illness, run by Al-Balqa Applied University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This research helps to close an important gap in the provision of care to ICU families and introduces a structured and accessible psychological intervention to family caregivers of long-stay ICU patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stress Management Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
20 Sep 2026to 20 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • A history of a psychiatric disorder that substantially impairs their ability to understand the study procedures, communicate effectively, or complete the study questionnaires reliably.

About this study

Official title: Effectiveness of a Stress Management Training Program in Reducing Caregiver Burden and Perceived Stress Among Families of Long-Stay ICU Patients

This research helps to close an important gap in the provision of care to ICU families and introduces a structured and accessible psychological intervention to family caregivers of long-stay ICU patients. The findings are expected to contribute to the integration of stress management training in family-centered nursing practices and contribute to improved psychological well-being of the caregivers of families in intensive care settings.

Read the 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.

Being tested
Stress Management Training Program
Keywords
Stress Management, Caregiver Burden, Perceived Stress, Intensive Care Unit, Family Caregivers, Stress Management Training
Medical subject headings
Critical Illness, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress Management Training ProgramBehavioural

    structured program of stress management training, including:

    • Education regarding stress, burden on caregivers and emotional response during ICU settings.
    • Identification of personal stressors of prolonged ICU hospitalization.
    • Cognitive techniques for recognizing and changing the negative or unhelpful thought patterns.
    • Problem-solving skills to manage challenges of care effective.
Study groups in NCT07812376
Study groupRoleWhat they receive
interventional groupExperimentalStress Management Training Program
Receives: Behavioral: Stress Management Training Program
control groupNo interventionno interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress Score

    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).

    Measured: 6 weeks

  2. Caregiver Burden as Measured by the 12-Item Zarit Burden Interview (ZBI-12)

    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).

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start20 Sep 2026 (estimated)
  3. Primary completion20 Nov 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812376
Sponsor's protocol ID
60/5/2025/2026
Status last verified
Sep 2026
First submitted
25 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31961831
  • 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.

    PubMed 7093670
  • 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.

    PubMed 39402480

Questions about this trial

What is this clinical trial studying?

A study testing Stress Management Training Program in people with Intensive Care Unit Syndrome and Critical Illness, run by Al-Balqa Applied University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Score (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07812376, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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