Psychiatric Nursing Intervention for Caregivers of Patients With Bipolar Disorder

NCT07548359 | Completed DMC

• 1 other identifier: BD-Caregiver-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Caregiver Burden; Psychological Resilience

Keywords

Psychiatric Nursing; Family Caregivers; Bipolar Disorder; Caregiver Burden; Psychological Resilience; Nursing Intervention; Mental Health

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  Baseline and 12 weeks after the intervention

Other Outcomes (1)

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

  Baseline and 12 weeks after the intervention

Study Arms (2)

Psychiatric Nursing Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in this group received routine care without the structured psychiatric nursing intervention.

Interventions

Psychiatric Nursing Intervention BEHAVIORAL

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

Psychiatric Nursing Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead
• Imam Mohammad ibn Saud Islamic University: collaborator
• Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia: collaborator

Study Sites (1)

Faculty of Nursing, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Bipolar Disorder; Caregiver Burden; Psychological Well-Being

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Yahya khatatbeh, phd

  Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial. No blinding was applied due to the nature of the psychiatric nursing intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Princess Nourah bint Abdulrahman University

Model Details: Participants were assigned to a single group and received a structured psychiatric nursing intervention. Outcomes were assessed before and after the intervention to evaluate its effectiveness.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: February 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 30, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)