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

Phase 3

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

Registration Number: CTRI/2024/02/062214

Lead Sponsor: AIIMS, New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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