Bipolar DisorderBD-CareNCT07548359
Psychiatric Nursing Intervention for Caregivers of Patients With Bipolar Disorder
A study testing Psychiatric Nursing Intervention in people with Bipolar Disorder and Caregiver Burden, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Caregiver Burden, Psychological Resilience
- What is being tested?
- Psychiatric Nursing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Bipolar Disorder, Caregiver Burden, Psychological Resilience
- Being tested
- Psychiatric Nursing Intervention
- Keywords
- Psychiatric Nursing, Family Caregivers, Bipolar Disorder, Caregiver Burden, Psychological Resilience, Nursing Intervention, Mental Health
- Medical subject headings
- Bipolar Disorder, Caregiver Burden, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric Nursing InterventionBehavioural
A structured psychiatric nursing intervention including psychoeducation, stress management, coping strategies, and emotional support aimed at improving caregiver outcomes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychiatric Nursing Intervention |
| Control Group | No intervention | Participants in this group received routine care without the structured psychiatric nursing intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline and 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Feb 2024
- Primary completion20 Dec 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Imam Mohammad ibn Saud Islamic University, Princess Nourah Bint Abdulrahman University
- Responsible party
- Principal investigator, Yahya Mubark Khatatbeh, Imam Mohammad ibn Saud Islamic University
- Investigators
- Yahya khatatbeh, phd, Principal investigator, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548359
- Sponsor's protocol ID
- BD-Caregiver-2026
- Acronym
- BD-Care
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Alhalawany RM, Khatatbeh YM, Mansour OZ, Hashem SR. 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. BMC Nurs. 2026 Sep 15;25(1):996. doi: 10.1186/s12912-026-05326-z.
PubMed 42902289
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07548359
- Acronym / sponsor ID
- BD-Care / BD-Caregiver-2026
- Conditions
- Bipolar Disorder, Caregiver Burden, Psychological Resilience
- Keywords
- Psychiatric Nursing, Family Caregivers, Bipolar Disorder, Caregiver Burden, Psychological Resilience, Nursing Intervention, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Imam Mohammad ibn Saud Islamic University, Princess Nourah Bint Abdulrahman University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Psychiatric Nursing Intervention Group | Experimental | Behavioral: Psychiatric Nursing InterventionParticipants 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. |
| Control Group | No intervention | –Participants in this group received routine care without the structured psychiatric nursing intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric Nursing InterventionA structured psychiatric nursing intervention including psychoeducation, stress management, coping strategies, and emotional support aimed at improving caregiver outcomes. | Behavioural | Psychiatric Nursing Intervention Group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Derived from this study: PubMed 42902289Alhalawany RM, Khatatbeh YM, Mansour OZ, Hashem SR. 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. BMC Nurs. 2026 Sep 15;25(1):996. doi: 10.1186/s12912-026-05326-z.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yahya khatatbeh, phd principal investigator
Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric Nursing Intervention in people with Bipolar Disorder and Caregiver Burden, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07548359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.