Feasibility Trial of Getting Better Bite by Bite for Eating Disorders (CaGBBB)

Pakistan Institute of Living and Learning

Status: Active, not recruiting

Conditions: Binge-Eating Disorder; Bulimia Nervosa; Eating Disorders

Treatments: Other: Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05724394

PILL-GBBB-ED

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Ca-GBBB arm

Experimental group

Description:

The Ca-GBBB strongly focuses on enhancing participant's motivation and belief in their ability to change. The intervention will be comprised of 16-week training program delivered over four months. Sessions will be delivered weekly and each session will last about 45-50 minutes. All sessions will be delivered by master level psychologist. The manual will be translated to Urdu giving special consideration to cultural adaptation of phrases and concepts to reflect Pakistani culture. Additionally, culturally appropriate case scenarios will be incorporated and a consensual view to addressing cultural factors such as gender role, financial difficulties will be taken into consideration. The time and venue of session will be decided prior according to participant convenience.

Treatment:

Other: Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention

Treatment As Usual

No Intervention group

Description:

Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4-month post-randomization.