ClinicalTrials.gg
Not yet recruitingNCT07812376Updated Sep 10, 2026

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

An interventional study of Stress Management Training Program in Intensive Care Unit Syndrome and Critical Illness, sponsored by Al-Balqa Applied University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Primary conditionCaregiver BurdenRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Caregiver Burden
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's title name Caregiver Burden.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Al-Balqa Applied University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intensive Care Unit Syndrome
  • Critical Illness

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Keywords

  • Stress Management
  • Caregiver Burden
  • Perceived Stress
  • Intensive Care Unit
  • Family Caregivers
  • Stress Management Training
03

In context

Caregiver Burden Reclassified

500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.

This study's planned enrollment of 50 is below the median of 71 across 402 interventional studies indexed under Caregiver Burden.

Browse Caregiver Burden studies →

Lead sponsor

Al-Balqa Applied University is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Compared within Caregiver Burden, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    interventional group

    Stress Management Training Program

    Behavioral: Stress Management Training Program

  • No intervention
    control group

    no interventions

Interventions

  • BehavioralStress Management Training Program

    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.

06

What researchers measure

Primary outcomes

  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).

    Time frame: 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).

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Nov 2026, 2 months later.

Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 2 months is below that.

Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Sep 10, 2026
StartEst.
Sep 20, 2026
Primary completionEst.
Nov 20, 2026
CompletionEst.
Dec 20, 2026
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07812376
Lead sponsor
Al-Balqa Applied University
Responsible party
Mutaz Fuad Ghleb Alradaydeh (Assistant Professor at Al-Balqa Applied University, Al-Balqa Applied University) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Nov 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Sep 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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