Clinical trial NCT05724394: Feasibility Trial of Getting Better Bite by Bite for Eating Disorders
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eating Disorders
Bulimia Nervosa
Binge-Eating Disorder
Keywords: Getting better bite by bite (GBBB)
Culturally Adapted Intervention
Low resource settings
Pakistan
Eating Disorders
Feasibility Study
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility Randomized Controlled Trial with participants randomized into two trial arms
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age18 years
2. Screen positive on the Binge Eating Screening Questionnaire and/or Bulimic Investigatory test, Edinburgh
3. Residents of the study catchment area
4. Able to provide informed consent

Exclusion Criteria:

1. Aged under 18
2. Presence of any severe mental or physical illness that would prevent individual from participating in the intervention and or assessments.
3. Temporary resident unlikely to be available for follow-up

Primary outcomes:
measure: Recruitment and attrition Logs
timeFrame: One year's time
measure: Intervention Log
timeFrame: During 4-month intervention period.
measure: Attendance logs
timeFrame: From baseline to 4-month follow up
measure: Client Satisfaction Questionnaire
timeFrame: From baseline to 4-month follow up
Secondary outcomes:
measure: The Bulimic Investigatory Test, Edinburgh
timeFrame: Change in score from baseline to 4-month follow-up.
measure: Binge-Eating Disorder Screener
timeFrame: Change in score from baseline to 4-month follow-up
measure: The Sick, Control, One, Fat, Food
timeFrame: Change in score from baseline to 4-month follow-up
measure: Eating Disorder Examination Questionnaire
timeFrame: Change in score from baseline to 4-month follow-up
measure: Kessler Psychological Distress Scale
timeFrame: Change in score from baseline to 4-month follow-up
measure: Beck Scale for Suicidal Ideation
timeFrame: Change in score from baseline to 4-month follow-up
measure: Beck Depression Inventory
timeFrame: Change in score from baseline to 4-month follow-up
measure: Oslo- 3 Social Support Scale
timeFrame: Change in score from baseline to 4-month follow-up
measure: Client Satisfaction Questionnaire
timeFrame: Change in score from baseline to 4-month follow-up
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore site
state: Punjab
Study officials:
References:
citation: Atwood ME, Friedman A. A systematic review of enhanced cognitive behavioral therapy (CBT-E) for eating disorders. Int J Eat Disord. 2020 Mar;53(3):311-330. doi: 10.1002/eat.23206. Epub 2019 Dec 16.