A feasibility randomized controlled trial of culturally adapted Getting Better Bite-by-Bite (Ca-GBBB) intervention for individuals with eating disorders in Pakistan.

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. DISCUSSION: 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. TRIAL REGISTRATION The study is registered on clinicaltrials.gov (NCT05724394). Protocol version (1.0. 1st June 2022).