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

NCT07812376 | Not Yet Recruiting

• 1 other identifier: 60/5/2025/2026
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Intensive Care Unit Syndrome; Critical Illness

Keywords

Stress Management; Caregiver Burden; Perceived Stress; Intensive Care Unit; Family Caregivers; Stress Management Training

Outcome Measures

Primary Outcomes (2)

• 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).

  6 weeks

• 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).

  6 weeks

Study Arms (2)

interventional group

EXPERIMENTAL

Stress Management Training Program

Behavioral: Stress Management Training Program

control group

NO INTERVENTION

no interventions

Interventions

Stress Management Training Program BEHAVIORAL

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.

interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Balqa Applied University: lead

Related Publications (3)

• 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.

  PMID: 31961831 BACKGROUND

• 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.

  PMID: 7093670 BACKGROUND

• 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.

  PMID: 39402480 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Caregiver Burden

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at Al-Balqa Applied University

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 10, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share