PDF(Pubmed)
Abstract：
BACKGROUND: Eating disorders (EDs) are serious mental health conditions that affect a person physically and psychologically. In the past, EDs were only recognized as a cultural phenomenon/societal by-product of the West. However, research evidence marks its presence in non-western countries also, including South Asia. This study aims to evaluate the feasibility and acceptability of a manualized psychological intervention called Getting Better Bite by Bite (GBBB) in individuals who screened positive on measures of EDs in Pakistan.
METHODS: The proposed study is a feasibility randomized controlled trial (fRCT). The study will be conducted at five sites across Pakistan: Karachi, Hyderabad, Lahore, Rawalpindi, and Multan to recruit a total of 80 participants. Eligible participants will be randomized to either (1) the intervention group; in which they will receive one-to-one sessions of GBBB along with routine care or (2) the routine care group; in which they will only have access to the routine care. We have received ethics approval by the National Bioethics Committee. The study is registered at clinicaltrials.gov (NCT05724394). The study team has received permission from recruitment centers: hospitals (i.e. the psychiatry department of public and private hospitals based in these cities), fitness centers (i.e., gyms), educational institutes (i.e., colleges and universities), and community settings (i.e. community health clinics). Self-referrals from General Practitioners and community settings will be accepted. The intervention manual has been translated into Urdu and a multidisciplinary team including service users has culturally adapted the content of intervention for local context.
CONCLUSIONS: This study will provide evidence on feasibility and acceptability of a culturally adapted intervention for individuals who screen positive on measures of EDs. The findings of this study will inform a fully powered Randomized Controlled Trial of the proposed intervention.
BACKGROUND: The study is registered on clinicaltrials.gov (NCT05724394). Protocol version (1.0. 1st June 2022).
METHODS: The proposed study is a feasibility randomized controlled trial (fRCT). The study will be conducted at five sites across Pakistan: Karachi, Hyderabad, Lahore, Rawalpindi, and Multan to recruit a total of 80 participants. Eligible participants will be randomized to either (1) the intervention group; in which they will receive one-to-one sessions of GBBB along with routine care or (2) the routine care group; in which they will only have access to the routine care. We have received ethics approval by the National Bioethics Committee. The study is registered at clinicaltrials.gov (NCT05724394). The study team has received permission from recruitment centers: hospitals (i.e. the psychiatry department of public and private hospitals based in these cities), fitness centers (i.e., gyms), educational institutes (i.e., colleges and universities), and community settings (i.e. community health clinics). Self-referrals from General Practitioners and community settings will be accepted. The intervention manual has been translated into Urdu and a multidisciplinary team including service users has culturally adapted the content of intervention for local context.
CONCLUSIONS: This study will provide evidence on feasibility and acceptability of a culturally adapted intervention for individuals who screen positive on measures of EDs. The findings of this study will inform a fully powered Randomized Controlled Trial of the proposed intervention.
BACKGROUND: The study is registered on clinicaltrials.gov (NCT05724394). Protocol version (1.0. 1st June 2022).
摘要：
背景：进食障碍（ED）是严重的心理健康状况，会影响人的身体和心理。在过去,ED仅被认为是西方的文化现象/社会副产品。然而,研究证据也标志着它在非西方国家的存在，包括南亚。这项研究旨在评估在巴基斯坦对ED措施进行阳性筛查的个体中，称为BiteBetterBite（GBBB）的手动心理干预的可行性和可接受性。
方法：拟议的研究是一项可行性随机对照试验（fRCT）。这项研究将在巴基斯坦的五个地点进行：卡拉奇，海得拉巴,拉合尔,拉瓦尔品第,和木尔坦共招募80名参与者。符合条件的参与者将被随机分配到（1）干预组;他们将接受一对一的GBBB课程以及常规护理或（2）常规护理组;他们只能获得常规护理。我们已经获得了国家生物伦理委员会的伦理批准。该研究在clinicaltrials.gov（NCT05724394）注册。研究小组已获得招聘中心的许可：医院（即这些城市的公立和私立医院的精神病学部门），健身中心(即，健身房)，教育机构(即，学院和大学)，和社区环境(即社区卫生诊所)。全科医生和社区环境的自我推荐将被接受。干预手册已被翻译成乌尔都语，包括服务用户在内的多学科团队在文化上根据当地情况调整了干预内容。
结论：这项研究将为筛查ED措施呈阳性的个体提供文化适应性干预措施的可行性和可接受性的证据。这项研究的结果将为拟议的干预措施提供完全有效的随机对照试验。
背景：该研究已在clinicaltrials.gov（NCT05724394）上注册。协议版本(1.0.2022年6月1日）。
方法：拟议的研究是一项可行性随机对照试验（fRCT）。这项研究将在巴基斯坦的五个地点进行：卡拉奇，海得拉巴,拉合尔,拉瓦尔品第,和木尔坦共招募80名参与者。符合条件的参与者将被随机分配到（1）干预组;他们将接受一对一的GBBB课程以及常规护理或（2）常规护理组;他们只能获得常规护理。我们已经获得了国家生物伦理委员会的伦理批准。该研究在clinicaltrials.gov（NCT05724394）注册。研究小组已获得招聘中心的许可：医院（即这些城市的公立和私立医院的精神病学部门），健身中心(即，健身房)，教育机构(即，学院和大学)，和社区环境(即社区卫生诊所)。全科医生和社区环境的自我推荐将被接受。干预手册已被翻译成乌尔都语，包括服务用户在内的多学科团队在文化上根据当地情况调整了干预内容。
结论：这项研究将为筛查ED措施呈阳性的个体提供文化适应性干预措施的可行性和可接受性的证据。这项研究的结果将为拟议的干预措施提供完全有效的随机对照试验。
背景：该研究已在clinicaltrials.gov（NCT05724394）上注册。协议版本(1.0.2022年6月1日）。
