An Observational Study to Explore the Association Between Beta Blocker Use and Depressive Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Chitkara University
- Enrollment
- 1,136
- Primary Endpoint
- An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes
Study Overview
Brief Summary
An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes
Detailed Description
Study design- This is a Prospective, Retrospective, Cross-sectional observational study. In prospective study, cardiovascular patients will be divided into two groups: those taking β-blockers and those not taking β-blockers. A questionnaire-based study will be conducted to assess the depression status of both groups. The study will include Depression Inventory (MDI) (lCD-10), Hamilton Rating Scale for Depression (HDRS) and Patient health questionnaire-9 (PHQ-9) for prospective study.
In the Retrospective study, clinically diagnosed depression patients with cardiovascular co morbidity will be identified from the psychiatric department.
Study population- Total number of patients to be included in both prospective and retrospective study: 1136 Prospective: 684 participants from cardiology department (two subgroups = 342 with β-blockers and other 342 without β-blockers) Retrospective: 452 participants from psychiatric department (two subgroups = 226 with β-blockers and other 226 without β-blockers) Planned time period for the study: Jan 2025 to May 2025 Procedure- Prospective: A prospective study, a total of 684 cardiovascular participants will be recruited from the Cardiology department. Participants will be divided into two groups: participants who are currently on β-blockers from at least 1 year and those who are not on β-blockers. Then a Depression Inventory (MDI) (lCD-10), Hamilton Rating Scale for Depression (HDRS) and PHQ-9 (Patient health questionnaire-9) depression questionnaire will be run on both to assess depression levels. Data collected from both groups will be compared to evaluate differences in depression status.
Retrospective: A retrospective study will be conducted involving 452 patients diagnosed with depression and atleast one cardiovascular co morbidity from the psychiatry department. Patients will be classified into two groups: those who were prescribed with β-blockers and those who were not. Medical records of these patients will be obtained from their respective Staff. The primary objective is to determine the prevalence of β-blocker use among depressed patients with cardiovascular conditions by reviewing their medical histories.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged from ≥18 years at the time of consent.
- •Participants on β-blockers for at least 1 year.
- •No significant cognitive impairment.
- •Participants who are willing to participate.
- •To be able to understand and answer the self-assessment questionnaires.
Exclusion Criteria
- •Having severe sensory and physical limitations, severe disconnection from the environment, or presence of severe neuropsychiatric symptoms that make it impossible to administer the assessment.
- •For Retrospective Study:-
- •Inclusion criteria:
- •Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
- •Participants with cardiovascular co-morbidity.
- •Participants aged from ≥18 years.
- •Exclusion criteria:
- •Depression with other psychiatric illness for e.g., schizophrenia, cognitive impairment and without any cardiac comorbidity.
Outcomes
Primary Outcomes
An Observational Study to Explore the Association Between β-Blocker Use and Depressive Outcomes
Time Frame: 6 months
β-blockers use are associated with antidepressant effect or not
Secondary Outcomes
No secondary outcomes reported