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临床试验/CTRI/2025/11/096929
CTRI/2025/11/096929尚未招募不适用

Adaptation and testing the acceptability and feasibility of a multicomponent lifestyle intervention program for first episode major depressive disorder: A mixed methods study

Department of Psychiatry1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
1
主要终点
The outcome will be acceptability & feasibility of the multicomponent lifestyle intervention program in reducing depressive symptoms and improving physical activity, diet & sleep of persons with first episode major depressive disorder

研究概览

简要总结

Title: Adaptation and testing the acceptability and feasibility of a multicomponent lifestyle intervention program for first episode major depressive disorder: A mixed method study

Introduction:

Depression disorders and NCD (cardiometabolic disorders etc) are common disorders worldwide and in India too. The recently published Global Burden of Disease (2020) reports India having 197.3 million had mental disorders in 2017; of which 45.7 million suffer from depressive disorders.1 India is experiencing the burden of rising rates of non-communicable diseases. According to a WHO report, in 2015, 5.8 million die from NCD every year. WHO projects annual number of death from NCD worldwide will increase to 55 million by 2030 without timely intervention for prevention and control. Both depressive disorder and NCD often coexist and also share the same risk factors i.e., unhealthy lifestyle.2 People diagnosed with depression tend to engage in unhealthy lifestyle behaviors including poor diet, sedentary behavior, smoking, and alcohol consumption. Additionally, the use of antidepressant used may lead to central obesity, high BP as well and high triglycerides level.3

Many previous studies targeting these shared modifiable lifestyle risk factors like physical activity, diet, sleep, etc have been reported in context to prevention and management of cardiometabolic disorders among persons diagnosed with mental disorders including depressive disorder from high-income countries but such pieces of evidence are lacking from low- and middle-income countries including India.4 Recently, there has been a growing evidence base that supports the efficacy & cost-effectiveness of lifestyle-based interventions in the prevention and management of mental health disorders.5

However, many of these lifestyle-based intervention studies have focused on specific healthy components rather than multi-component lifestyle intervention programs which provide greater health benefits and are cost-effective.6

 Additionally, to the best of my knowledge, no study has been conducted so far in Indian setting for testing the acceptability & feasibility of a culturally adapted multicomponent lifestyle intervention provided from the initial or first episode of major depressive disorder for dual benefit in reducing the symptoms as well as ensuring adoption of healthy lifestyle interventions.

   Objectives:

Obj 1: To adapt evidence- based lifestyle interventions to reduce depressive symptoms and improve physical activity, diet & sleep among persons with first episode major depressive disorder

Obj 2: To assess the acceptability and feasibility of the multicomponent lifestyle intervention program among persons with first episode major depressive disorder

Population to be studied: First episode major depressive disorder attending Psychiatric OPD

Intervention: Multicomponent Lifestyle Intervention Program

Study Design: Intervention Mapping & single group feasibility study

Study setting: Psychiatry Out patient Services (OPD), Department of Psychiatry, Govt Medical College & Hospital, Chandigarh

Study period: 3 years

Subject Recruitment: Prospective

Target sample size: 36

Outcome of the study: The outcome will be acceptability & feasibility of the multicomponent lifestyle intervention program in reducing depressive symptoms and improving physical activity, diet & sleep of persons with first episode major depressive disorder.

References:

  1. India State-Level Disease Burden Initiative Mental Disorders Collaborators. The burden of mental disorders across the states of India: the Global Burden of Disease Study 1990-2017. Lancet Psychiatry. 2020 Feb;7(2):148–61.

  2. Stein DJ, Benjet C, Gureje O, Lund C, Scott KM, Poznyak V, et al. Integrating mental health with other non-communicable diseases. BMJ. 2019 Jan 28;364: 295.

  3. Moradi Y, Albatineh AN, Mahmoodi H, Gheshlagh RG. The relationship between depression and risk of metabolic syndrome: a meta-analysis of observational studies. Clin Diabetes Endocrinol. 2021 Mar 2;7(1):4.

  4. Firth J, Siddiqi N, Koyanagi AI, Siskind D, Rosenbaum S, Galletly C, et al. The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness. The Lancet Psychiatry. 2019;6(8):675–712.

  5. Marx W, Jacka F, O’Neil A. Lifestyle-based mental health care in psychiatry: Translating evidence into practice. Aust N Z J Psychiatry. 2021 Jul;55(7):641–3.

  6. Gómez-Gómez I, Motrico E, Moreno-Peral P, Rigabert A, Conejo-Cerón S, Ortega-Calvo M, et al. Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2019 Mar 15;9(3):e026842.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 65 years
  • Diagnosed with the first episode of major depression as per ICD-11
  • Possess a smartphone
  • Able to read and speak Hindi or English or Punjabi
  • Willingness to provide informed consent and comply with the study protocol.

排除标准

  • Subject with comorbidity of diabetes mellitus type I or II, CVD, HTN, dyslipidemia, or another serious medical and neurocognitive disorder (which may interfere with adherence of the lifestyle interventions); and use of medication that interferes with weight or thyroid medications, comorbid substance dependence except for nicotine & caffeine
  • Subjects with recurrent depressive disorder, bipolar disorder, comorbidity with acute psychosis or mania episodes, eating disorder
  • Current suicidal tendencies
  • Pregnancy
  • Current hospitalization.

结局指标

主要结局

The outcome will be acceptability & feasibility of the multicomponent lifestyle intervention program in reducing depressive symptoms and improving physical activity, diet & sleep of persons with first episode major depressive disorder

时间窗: 3, 6 month after intervention delivered

次要结局

未报告次要终点

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Virtu Chongtham

Department of Nursing , Chitkara School of Health Sciences

研究点 (1)

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