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NCT Number: NCT07548359

Psychiatric Nursing Intervention for Caregivers of Patients With Bipolar Disorder

This study aims to evaluate the effectiveness of an innovative psychiatric nursing intervention in reducing caregiver burden and enhancing psychological resilience and positive emotional outcomes among family caregivers of patients with bipolar disorder. Family caregivers often experience significant psychological stress and emotional challenges due to the chronic and recurrent nature of bipolar disorder.

This interventional study was conducted among family caregivers recruited from the Faculty of Nursing, Menoufia University. Participants received a structured psychiatric nursing intervention designed to improve coping strategies, emotional regulation, and resilience.

The outcomes of the study include changes in caregiver burden, psychological resilience, and positive emotional outcomes following the intervention. The findings are expected to contribute to improving mental health support for caregivers and enhancing the quality of care provided to patients with bipolar disorder.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Caregiver Burden Mental Disorders Mood Disorders Personal Satisfaction Psychological Resilience Psychological Well-Being Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

About this study

Bipolar disorder is a chronic mental health condition characterized by recurrent episodes of mania and depression, which significantly affects both patients and their family caregivers. Caregivers often experience substantial psychological burden, stress, and reduced emotional well-being.

This study was designed as an interventional study to assess the effectiveness of an innovative psychiatric nursing intervention aimed at improving caregiver outcomes. The intervention focuses on psychoeducation, stress management, coping strategies, and emotional support to enhance psychological resilience and positive emotional outcomes.

The study was conducted at the Faculty of Nursing, Menoufia University, Egypt, and involved family caregivers of patients diagnosed with bipolar disorder. Participants were exposed to a structured psychiatric nursing intervention delivered over a defined period.

Primary outcomes include reduction in caregiver burden and improvement in psychological resilience, while secondary outcomes include enhancement of positive emotional states. Standardized assessment tools were used to evaluate outcomes before and after the intervention.

The results of this study are expected to provide evidence for the effectiveness of psychiatric nursing interventions in supporting caregivers of patients with bipolar disorder and improving their psychological well-being.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult family caregivers aged 18 years or older.
  • Primary caregivers of patients diagnosed with bipolar disorder.
  • Providing care for at least 6 months.
  • Able to understand and communicate effectively.
  • Willing to participate and provide informed consent.

Exclusion criteria

  • Caregivers with diagnosed severe psychiatric disorders.
  • Caregivers currently receiving structured psychological or psychiatric intervention.
  • Caregivers with cognitive impairment affecting participation.
  • Refusal to participate or inability to complete the study procedures.

Treatment and study plan

Psychiatric Nursing Intervention

Behavioral

A structured psychiatric nursing intervention including psychoeducation, stress management, coping strategies, and emotional support aimed at improving caregiver outcomes.

Primary outcomes

  1. Change in caregiver burden from baseline to 12 weeks after the intervention, measured using the Zarit Burden Interview (ZBI).

    Time frame: Baseline and 12 weeks after the intervention

    Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated instrument measuring the perceived burden among caregivers. Scores range from lower to higher values, with higher scores indicating greater caregiver burden. Changes in scores from baseline to 12 weeks post-intervention will be analyzed.

Secondary outcomes

  1. Change in positive emotional outcomes from baseline to 12 weeks after the intervention, measured using a validated emotional well-being scale.

    Time frame: Baseline and 12 weeks after the intervention

    Psychological resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), a validated scale assessing the ability to cope with stress and adversity. Higher scores indicate greater resilience. Changes from baseline to 12 weeks post-intervention will be evaluated.

Other outcomes

  1. Change in positive emotional outcomes from baseline to 12 weeks after the intervention, measured using a validated emotional well-being scale.

    Time frame: Baseline and 12 weeks after the intervention

    Positive emotional outcomes will be assessed using a validated emotional well-being scale. The scale evaluates positive affect and emotional stability, with higher scores reflecting better emotional well-being. Changes from baseline to 12 weeks after the intervention will be analyzed.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Imam Mohammad ibn Saud Islamic University
  • Princess Nourah Bint Abdulrahman University

Registry information

Official study title

From Caregiver Burden to Psychological Resilience and Positive Emotional Outcomes: The Effectiveness of Innovative Psychiatric Nursing Intervention Among Family Caregivers of Patients With Bipolar Disorder

Acronym: BD-Care

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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