Nagendra P Luitel, Brandon A Kohrt, Bishnu Lamichhane, Anvita Bhardwaj, Kamal Gautam, Mark Jd Jordans
{"title":"优化以社区为基础的干预措施以改善抑郁症治疗的求助:随机因子试验的研究方案。","authors":"Nagendra P Luitel, Brandon A Kohrt, Bishnu Lamichhane, Anvita Bhardwaj, Kamal Gautam, Mark Jd Jordans","doi":"10.1186/s13063-025-09014-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Depression is a common mental health issue that can be effectively managed in primary and community health care settings. However, there is a significant gap between the number of individuals in need of care and those who actually receive treatment, with the greatest gap in low- and middle-income countries (LMICs). Although efforts have been made in LMICs to improve access to mental health services by addressing supply-side barriers, there has been less attention to demand-side obstacles. On the demand side, factors such as stigma, negative attitudes, and limited awareness of available services lead to underutilization of mental health services. This protocol describes a study of active ingredients of a community-based intervention aimed at enhancing help-seeking for depression care in Nepal, a LMIC with low rates of mental health treatment seeking.</p><p><strong>Methods: </strong>The study will take place in two municipalities in eastern Nepal, utilizing the Multiphase Optimization Strategy (MOST) with a 2 × 3 factorial randomized controlled trial design. Female Community Health Volunteers will be trained to identify individuals with depression using the Community Informant Detection Tool, a proven community-based strategy for proactive case detection, and subsequently implement the Gain Life intervention, which aims to promote help-seeking for depression care. The Gain Life intervention comprises four components: (i) information about depression, (ii) awareness of available services, (iii) stigma reduction by dispelling myths and facts about depression, and (iv) a life transformation story. The study will target the adult population, with eligibility criteria including being 18 years or older, residing in specific municipalities, meeting the CIDT threshold for depression, providing consent, and having proficiency in Nepali. The sample size will be 288, with the primary outcome being help-seeking behaviour.</p><p><strong>Discussion: </strong>In this protocol paper, we outline how the MOST framework can optimize a community-based intervention aimed at improving help-seeking for depression care. The findings from this study will guide decisions on whether to proceed with a fully randomized controlled trial or conduct an additional optimization study to finalize the intervention components.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06574074. Registered on 27 August 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"293"},"PeriodicalIF":2.0000,"publicationDate":"2025-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12358067/pdf/","citationCount":"0","resultStr":"{\"title\":\"Optimizing a community-based intervention to improve help-seeking for depression care: study protocol for a randomized factorial trial.\",\"authors\":\"Nagendra P Luitel, Brandon A Kohrt, Bishnu Lamichhane, Anvita Bhardwaj, Kamal Gautam, Mark Jd Jordans\",\"doi\":\"10.1186/s13063-025-09014-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Depression is a common mental health issue that can be effectively managed in primary and community health care settings. 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Female Community Health Volunteers will be trained to identify individuals with depression using the Community Informant Detection Tool, a proven community-based strategy for proactive case detection, and subsequently implement the Gain Life intervention, which aims to promote help-seeking for depression care. The Gain Life intervention comprises four components: (i) information about depression, (ii) awareness of available services, (iii) stigma reduction by dispelling myths and facts about depression, and (iv) a life transformation story. The study will target the adult population, with eligibility criteria including being 18 years or older, residing in specific municipalities, meeting the CIDT threshold for depression, providing consent, and having proficiency in Nepali. 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Optimizing a community-based intervention to improve help-seeking for depression care: study protocol for a randomized factorial trial.
Background: Depression is a common mental health issue that can be effectively managed in primary and community health care settings. However, there is a significant gap between the number of individuals in need of care and those who actually receive treatment, with the greatest gap in low- and middle-income countries (LMICs). Although efforts have been made in LMICs to improve access to mental health services by addressing supply-side barriers, there has been less attention to demand-side obstacles. On the demand side, factors such as stigma, negative attitudes, and limited awareness of available services lead to underutilization of mental health services. This protocol describes a study of active ingredients of a community-based intervention aimed at enhancing help-seeking for depression care in Nepal, a LMIC with low rates of mental health treatment seeking.
Methods: The study will take place in two municipalities in eastern Nepal, utilizing the Multiphase Optimization Strategy (MOST) with a 2 × 3 factorial randomized controlled trial design. Female Community Health Volunteers will be trained to identify individuals with depression using the Community Informant Detection Tool, a proven community-based strategy for proactive case detection, and subsequently implement the Gain Life intervention, which aims to promote help-seeking for depression care. The Gain Life intervention comprises four components: (i) information about depression, (ii) awareness of available services, (iii) stigma reduction by dispelling myths and facts about depression, and (iv) a life transformation story. The study will target the adult population, with eligibility criteria including being 18 years or older, residing in specific municipalities, meeting the CIDT threshold for depression, providing consent, and having proficiency in Nepali. The sample size will be 288, with the primary outcome being help-seeking behaviour.
Discussion: In this protocol paper, we outline how the MOST framework can optimize a community-based intervention aimed at improving help-seeking for depression care. The findings from this study will guide decisions on whether to proceed with a fully randomized controlled trial or conduct an additional optimization study to finalize the intervention components.
Trial registration: ClinicalTrials.gov NCT06574074. Registered on 27 August 2024.
期刊介绍:
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.