Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT05724394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial of Getting Better Bite by Bite for Eating Disorders
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Study Overview
Official Title:
A Feasibility Randomized Controlled Trial of Culturally Adapted Getting Better Bite-by-Bite (Ca-GBBB)Intervention for Individuals With Eating Disorders in Pakistan
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaGBBB
Brief Summary:
This is a mixed method feasibility randomized controlled trial to explore the feasibility and acceptability of therapist delivered, culturally adapted, manualized Ca-GBBB intervention for Eating Disorders (EDs) - Bulimia Nervosa (BN) and Bing Eating Disorder (BED) in Pakistan.
Detailed Description:
Evidence on psychological management of eating disorders in low and middle income countries ( LMICs) is limited, and non-existent in Pakistan. A Cognitive Behaviour Therapy (CBT) based guided self-help manual "Getting Better Bite by Bite: A Survival Kit for Sufferers of Bulimia Nervosa and Binge Eating Disorders" (GBBB), has found to be feasible and acceptable for patients with BN.
Quantitative phase of this research aims to determine if the culturally adapted GBBB (Ca-GBBB) programme is feasible and acceptable for individuals with Eating disorders- BN and BED compared to treatment as usual.
The qualitative part of the study will include focus groups and in-depth digitally recorded one-to-one interviews with participants by trained qualitative researchers at two time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. Moreover, in-depth digitally-recorded interviews with stakeholders (nutritionists, dietitian, educationist, therapists, health professionals, etc) will also be conducted by trained researchers.
Quantitative phase of this research aims to determine if the culturally adapted GBBB (Ca-GBBB) programme is feasible and acceptable for individuals with Eating disorders- BN and BED compared to treatment as usual.
The qualitative part of the study will include focus groups and in-depth digitally recorded one-to-one interviews with participants by trained qualitative researchers at two time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. Moreover, in-depth digitally-recorded interviews with stakeholders (nutritionists, dietitian, educationist, therapists, health professionals, etc) will also be conducted by trained researchers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: