A feasibility randomized controlled trial of culturally adapted Getting Better Bite-by-Bite (Ca-GBBB) intervention for individuals with eating disorders in Pakistan.
Binge eating
Bite by bite
Bulimia nervosa
Cultural adaptation
Eating disorders
LMICs
Mental health
Pakistan
Psychological intervention
Journal
Journal of eating disorders
ISSN: 2050-2974
Titre abrégé: J Eat Disord
Pays: England
ID NLM: 101610672
Informations de publication
Date de publication:
17 Jul 2024
17 Jul 2024
Historique:
received:
18
01
2024
accepted:
01
06
2024
medline:
18
7
2024
pubmed:
18
7
2024
entrez:
17
7
2024
Statut:
epublish
Résumé
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. 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. 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. The study is registered on clinicaltrials.gov (NCT05724394). Protocol version (1.0. 1st June 2022).
Sections du résumé
BACKGROUND
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
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
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.
TRIAL REGISTRATION
BACKGROUND
The study is registered on clinicaltrials.gov (NCT05724394). Protocol version (1.0. 1st June 2022).
Identifiants
pubmed: 39020405
doi: 10.1186/s40337-024-01038-4
pii: 10.1186/s40337-024-01038-4
doi:
Banques de données
ClinicalTrials.gov
['NCT05724394']
Types de publication
Journal Article
Langues
eng
Pagination
100Subventions
Organisme : Pakistan Institute of Living and Learning
ID : ED/PILL/2022
Informations de copyright
© 2024. The Author(s).
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