Psychiatric Nursing Intervention for Caregivers of Patients With Bipolar Disorder (BD-Care)

April 16, 2026 updated by: Yahya Mubark Khatatbeh, Menoufia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibīn al Kawm, Menoufia, Egypt
        • Faculty of Nursing, Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychiatric Nursing Intervention Group
Participants in this group received a structured psychiatric nursing intervention designed to reduce caregiver burden and enhance psychological resilience and positive emotional outcomes among family caregivers of patients with bipolar disorder.
Behavioral: Psychiatric Nursing Intervention
A structured psychiatric nursing intervention including psychoeducation, stress management, coping strategies, and emotional support aimed at improving caregiver outcomes.
No Intervention: Control Group
Participants in this group received routine care without the structured psychiatric nursing intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Collaborators

Imam Mohammad ibn Saud Islamic University
Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia

Investigators

  • Principal Investigator: Yahya khatatbeh, phd, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-Caregiver-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The study data are confidential and were collected for research purposes only. Access to the data is restricted to the research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on Psychiatric Nursing Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe