Major Depressive Disorder (MDD)NCT06992167
Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan
An observational study of Major Depressive Disorder (MDD), run by Rahmah Health Foundation at 4 sites in Pakistan.
Trial summary
This cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like Pakistan. Caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 402 participants
- Where
- 4 sitesPakistan
- Study dates
- 1 May 2024to 10 May 2025
- Phase
- Observational
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of primary caregivers of breast cancer patients receiving treatment in public or private healthcare facilities in low-resource settings of Pakistan. Caregivers include family members or individuals who are directly involved in providing physical, emotional, or financial support to the patient.
Who may be able to join
- Primary caregiver of a patient diagnosed with breast cancer at any stage
- Male or female caregiver
- Aged 15 years or older
- Providing physical, emotional, or financial support to the patient
- Willing to give informed consent
Who cannot join
- Paid caregivers (professional or hired help)
- Age under 15 years
- Unwilling to provide consent or participate in the study
- Incomplete or missing essential data required for analysis
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Ayub Teaching Hospital
Abbottabad, Pubjab
Jinnah Postgraduate Medical Center
Karachi, Sindh
Nishtar Medical University and Hospital
Multan, Punjab Province
Benazir Bhutto Hospital
Rawalpindi
About this study
This cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like Pakistan. Caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. However, there is limited data from low- and middle-income countries, including Pakistan, where caregivers may face additional socioeconomic and systemic burdens. This study seeks to quantify the burden of depression in this population and explore associated sociodemographic and caregiving-related factors. Findings will help inform psychosocial support strategies and interventions to improve caregiver well-being in resource-constrained environments.
- Conditions
- Major Depressive Disorder (MDD)
- Medical subject headings
- Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression among caregivers of breast cancer patients
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool. The PHQ-9 consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27. Higher scores indicate worse depressive symptoms. Depression severity will be categorized as follows:
0-4: Minimal
5-9: Mild
10-14: Moderate
15-19: Moderately Severe
20-27: Severe
The proportion of caregivers falling into each category will be reported.
Measured: At a single time point during caregiver recruitment (cross-sectional assessment within 6 months of study initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 May 2024
- Primary completion30 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rahmah Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Usman Hashmi, Rahmah Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992167
- Sponsor's protocol ID
- RHF-04-2024
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan
- ClinicalTrials.gov ID
- NCT06992167
- Acronym / sponsor ID
- RHF-04-2024
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Rahmah Health FoundationUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 28 May 2025 (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 cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like Pakistan. Caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. However, there is limited data from low- and middle-income countries, including Pakistan, where caregivers may face additional socioeconomic and systemic burdens. This study seeks to quantify the burden of depression in this population and explore associated sociodemographic and caregiving-related factors. Findings will help inform psychosocial support strategies and interventions to improve caregiver well-being in resource-constrained environments.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of primary caregivers of breast cancer patients receiving treatment in public or private healthcare facilities in low-resource settings of Pakistan. Caregivers include family members or individuals who are directly involved in providing physical, emotional, or financial support to the patient.
Key inclusion criteria (5 listed)
- Primary caregiver of a patient diagnosed with breast cancer at any stage
- Male or female caregiver
- Aged 15 years or older
- Providing physical, emotional, or financial support to the patient
- Willing to give informed consent
Key exclusion criteria (4 listed)
- Paid caregivers (professional or hired help)
- Age under 15 years
- Unwilling to provide consent or participate in the study
- Incomplete or missing essential data required for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of depression among caregivers of breast cancer patients
Time frame: At a single time point during caregiver recruitment (cross-sectional assessment within 6 months of study initiation)
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool. The PHQ-9 consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27. Higher scores indicate worse depressive symptoms. Depression severity will be categorized as follows: 0-4: Minimal 5-9: Mild 10-14: Moderate 15-19: Moderately Severe 20-27: Severe The proportion of caregivers falling into each category will be reported.
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 28 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Rahmah Health Foundation at 4 sites in Pakistan.
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 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. 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?
Prevalence of depression among caregivers of breast cancer patients (time frame: At a single time point during caregiver recruitment (cross-sectional assessment within 6 months of study initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.