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A study to compare a manual assisted brief intervention for cardiovascular risk reduction, with care as usual in patients with depression

A study to develop and evaluate a manual-assisted, tailored brief intervention (BI) for cardiovascular risk reduction (vs care as usual) in patients with depression: A two-arm parallel randomized control trial (RCT) - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062214
Enrollment
300
Registered
2024-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F334- Major depressive disorder, recurrent, in remission Health Condition 2: F325- Major depressive disorder, singleepisode, in full remission Health Condition 3: F324- Major depressive disorder, singleepisode, in partial remission

Interventions

Intervention1: Brief Intervention sessions: A total of two in-person Brief Intervention (BI) sessions, at 4 weeks apart, each lasting about 30 minutes will be delivered. (Total duration of interventio

Sponsors

AIIMS, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Aged between 30-59 years Either gender ICD-11 Depressive Disorders - in complete or partial remission/stabilized on treatment 17-item Hamilton Depression Rating Scale (HAM-D) =13 Presence of elevated 10-year risk estimation for CVD on modified Framingham Risk Score (FRS) (i.e. all those in yellow or red zone in coding)

Exclusion criteria

Exclusion criteria: Any known/established or pre-existing cardiac illness will be an exclusion, that includes:-known history of coronary heart disease (CHD) such as myocardial infarction, stable/unstable angina, history of angioplasty etc or any evidence of clinically significant myocardial ischemia. Known Diabetes OR any other CHD Risk equivalent condition (e.g. CKD); Any noncoronary atherosclerotic disease )e.g. carotid or peripheral vascular idsease) Any significant neurological illness or intellectual disability or physical disability Any major/uncontrolled medical illness which precludes participation Pregnant women Any co-occuring severe mental illness e.g. schizophrenia/ psychotic disorder etc Not willing to participate and refuses for informed consent

Design outcomes

Primary

MeasureTime frame
Fasting Lipid profile: Total Cholesterol , HDL Cholesterol and LDL Cholesterol , Triglycerides Glycated haemoglobin (HbA1C) Blood pressure (SBP, DBP) Body mass index (BMI), Waist cirumference , waist to hip 10-year cardiovascular (CV) risk estimation score Readiness Rulers (1-10) for behavioral change Timepoint: Three time-points: at baseline, 3 months and 6 months

Secondary

MeasureTime frame
Global Physical Activity Questionnaire (GPAQ) Starting the conversation (STC) Dietary toolFagerstrom Nicotine dependence scale (smoking/smokeless) Alcohol Use Disorders Identification Test-C (AUDIT-C) DASS-21 item (Depression Anxiety Stress Scale) Health Promoting Lifestyle profile II (adult verison) EQ-5D Quality of Life tool Medication Adherence Rating ScaleTimepoint: Three time-points: at baseline, 3 months & 6 months

Countries

India

Contacts

Public ContactDr Raman Deep

AIIMS, New Delhi

drramandeep@gmail.com26593236

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026