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

Primary Purpose

Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Getting better bite by bite (GBBB), Culturally Adapted Intervention, Low resource settings, Pakistan, Eating Disorders, Feasibility Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age18 years Screen positive on the Binge Eating Screening Questionnaire and/or Bulimic Investigatory test, Edinburgh Residents of the study catchment area Able to provide informed consent Exclusion Criteria: Aged under 18 Presence of any severe mental or physical illness that would prevent individual from participating in the intervention and or assessments. Temporary resident unlikely to be available for follow-up

Sites / Locations

  • Lahore siteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ca-GBBB arm

Treatment As Usual

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

Outcomes

Primary Outcome Measures

Recruitment and attrition Logs
The parameters feasibility of undertaking the trial of intervention will include the recruitment rate (the number of patients referred/approached, proportion of those who consented out of all the eligible patients with BED and/or BN disorder referred from and approached at the recruitment sites) (The success criterion of feasibility will be to recruit > 50% of eligible participants) and the attrition rate (the number of patients withdrawn out of those who consented to participate).
Intervention Log
Feasibility of the intervention delivery: Duration of each session and completed feedback forms. This will be assessed by keeping record of whether the Ca-GBBB is delivered, received and enacted as intended.
Attendance logs
Therapy logs will include each participant's attendance in a session. This will give information about acceptability of intervention. mean attendance rate of >70% i.e. at least 11 sessions, will indicate that the intervention is acceptable for the participants
Client Satisfaction Questionnaire
Tolerability of the intervention is defined as the ability to endure the intervention. Items on Client Satisfaction Questionnaire are scored on a four-point Likert scale from 1 (low satisfaction) to 4 (high satisfaction), with different descriptors for each response point. Totals range from 8 to 32; with higher scores indicating greater satisfaction.

Secondary Outcome Measures

The Bulimic Investigatory Test, Edinburgh
The BITE is a 33-item self-rating scale (Henderson and Freeman 1987). It consists of two subscales: The Symptom Scale (30 items), which measures the degree of symptoms and the Severity Scale (3 items), which provides an index of the severity as defined by the frequency of binge-eating and purging behavior. The total score for all the questions gives a "symptom score" - a score of 15 or above indicate that the individuals has a lot of thoughts and attitudes consistent with eating disorders. The toral score of question 6, 7 and 27 will give a severity index - a score of 5 or above signifies an eating disorder
Binge-Eating Disorder Screener
The 7-item Binge-Eating Disorder Screener (BEDS-7), a brief screener for BED, can assist physicians in identifying patients who may have BED. Those with a score of 2-3 are considered mildly at risk of BED, a score of 4-5 is determined to be moderately at risk for BED, and a score of 6 indicates severely at risk for BED
The Sick, Control, One, Fat, Food
5 item questionnaire that covers the main three domains which are anorexia nervosa, bulimia nervosa, or other eating disorders. Each yes answer means 1 point and if the interviewee gets 2 points it reveals that he/she has anorexia nervosa or bulimia.
Eating Disorder Examination Questionnaire
a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score. Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes. A cut-off of 4 on the global score is generally used as clinically significant
Kessler Psychological Distress Scale
It is used to measure psychological distress. It's a 10 item scale measuring emotional states with a 5 level response scale. Scores will range from 10 to 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. score 10 - 19 Likely to be well, 20 - 24 Likely to have a mild disorder, 25 - 29 Likely to have a moderate disorder and 30 - 50 Likely to have a severe disorder
Beck Scale for Suicidal Ideation
The BSS is a 21-item measure that will be used to assess the frequency and intensity of suicidal thoughts. Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38. Individuals answer to the first 5 items which is excerpted. If individual's answer to the fifth item is positive (scores 1 and 2), he/she answers the rest of the items and otherwise the questionnaire is completed. No cut- point is used to categorize the scores
Beck Depression Inventory
The BDI is a 29 item questionnaire that will be used to measure severity of depression. Score 1-10 are considered normal, 11-16 Mild mood disturbance, 17-20 Borderline clinical depression, 21-30 Moderate depression, 31-40 Severe depression over 40 Extreme depression
Oslo- 3 Social Support Scale
O3SSS will be used to assess the relationship with friends, family and neighbors. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support. The OSSS-3 sum score can be operationalized into three broad categories of social support: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support
Client Satisfaction Questionnaire
Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction

Full Information

First Posted
December 9, 2022
Last Updated
March 31, 2023
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT05724394
Brief Title
Feasibility Trial of Getting Better Bite by Bite for Eating Disorders
Acronym
CaGBBB
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility Randomized Controlled Trial with participants randomized into two trial arms
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to the treatment allocation.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ca-GBBB arm
Arm Type
Experimental
Arm 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.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4-month post-randomization.
Intervention Type
Other
Intervention Name(s)
Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Recruitment and attrition Logs
Description
The parameters feasibility of undertaking the trial of intervention will include the recruitment rate (the number of patients referred/approached, proportion of those who consented out of all the eligible patients with BED and/or BN disorder referred from and approached at the recruitment sites) (The success criterion of feasibility will be to recruit > 50% of eligible participants) and the attrition rate (the number of patients withdrawn out of those who consented to participate).
Time Frame
One year's time
Title
Intervention Log
Description
Feasibility of the intervention delivery: Duration of each session and completed feedback forms. This will be assessed by keeping record of whether the Ca-GBBB is delivered, received and enacted as intended.
Time Frame
During 4-month intervention period.
Title
Attendance logs
Description
Therapy logs will include each participant's attendance in a session. This will give information about acceptability of intervention. mean attendance rate of >70% i.e. at least 11 sessions, will indicate that the intervention is acceptable for the participants
Time Frame
From baseline to 4-month follow up
Title
Client Satisfaction Questionnaire
Description
Tolerability of the intervention is defined as the ability to endure the intervention. Items on Client Satisfaction Questionnaire are scored on a four-point Likert scale from 1 (low satisfaction) to 4 (high satisfaction), with different descriptors for each response point. Totals range from 8 to 32; with higher scores indicating greater satisfaction.
Time Frame
From baseline to 4-month follow up
Secondary Outcome Measure Information:
Title
The Bulimic Investigatory Test, Edinburgh
Description
The BITE is a 33-item self-rating scale (Henderson and Freeman 1987). It consists of two subscales: The Symptom Scale (30 items), which measures the degree of symptoms and the Severity Scale (3 items), which provides an index of the severity as defined by the frequency of binge-eating and purging behavior. The total score for all the questions gives a "symptom score" - a score of 15 or above indicate that the individuals has a lot of thoughts and attitudes consistent with eating disorders. The toral score of question 6, 7 and 27 will give a severity index - a score of 5 or above signifies an eating disorder
Time Frame
Change in score from baseline to 4-month follow-up.
Title
Binge-Eating Disorder Screener
Description
The 7-item Binge-Eating Disorder Screener (BEDS-7), a brief screener for BED, can assist physicians in identifying patients who may have BED. Those with a score of 2-3 are considered mildly at risk of BED, a score of 4-5 is determined to be moderately at risk for BED, and a score of 6 indicates severely at risk for BED
Time Frame
Change in score from baseline to 4-month follow-up
Title
The Sick, Control, One, Fat, Food
Description
5 item questionnaire that covers the main three domains which are anorexia nervosa, bulimia nervosa, or other eating disorders. Each yes answer means 1 point and if the interviewee gets 2 points it reveals that he/she has anorexia nervosa or bulimia.
Time Frame
Change in score from baseline to 4-month follow-up
Title
Eating Disorder Examination Questionnaire
Description
a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score. Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes. A cut-off of 4 on the global score is generally used as clinically significant
Time Frame
Change in score from baseline to 4-month follow-up
Title
Kessler Psychological Distress Scale
Description
It is used to measure psychological distress. It's a 10 item scale measuring emotional states with a 5 level response scale. Scores will range from 10 to 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. score 10 - 19 Likely to be well, 20 - 24 Likely to have a mild disorder, 25 - 29 Likely to have a moderate disorder and 30 - 50 Likely to have a severe disorder
Time Frame
Change in score from baseline to 4-month follow-up
Title
Beck Scale for Suicidal Ideation
Description
The BSS is a 21-item measure that will be used to assess the frequency and intensity of suicidal thoughts. Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38. Individuals answer to the first 5 items which is excerpted. If individual's answer to the fifth item is positive (scores 1 and 2), he/she answers the rest of the items and otherwise the questionnaire is completed. No cut- point is used to categorize the scores
Time Frame
Change in score from baseline to 4-month follow-up
Title
Beck Depression Inventory
Description
The BDI is a 29 item questionnaire that will be used to measure severity of depression. Score 1-10 are considered normal, 11-16 Mild mood disturbance, 17-20 Borderline clinical depression, 21-30 Moderate depression, 31-40 Severe depression over 40 Extreme depression
Time Frame
Change in score from baseline to 4-month follow-up
Title
Oslo- 3 Social Support Scale
Description
O3SSS will be used to assess the relationship with friends, family and neighbors. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support. The OSSS-3 sum score can be operationalized into three broad categories of social support: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support
Time Frame
Change in score from baseline to 4-month follow-up
Title
Client Satisfaction Questionnaire
Description
Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction
Time Frame
Change in score from baseline to 4-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age18 years Screen positive on the Binge Eating Screening Questionnaire and/or Bulimic Investigatory test, Edinburgh Residents of the study catchment area Able to provide informed consent Exclusion Criteria: Aged under 18 Presence of any severe mental or physical illness that would prevent individual from participating in the intervention and or assessments. Temporary resident unlikely to be available for follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tayyeba Kiran, PhD
Phone
02135871845
Email
tayyaba.kiran@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Ameer B Khoso, PhD fellow
Phone
02135871845
Email
ameer.bukhsh@pill.org.pk
Facility Information:
Facility Name
Lahore site
City
Lahore
State/Province
Punjab
ZIP/Postal Code
203393
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tayyeba Kiran
Email
tayyaba.kiran@pill.org.pk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The anonymised data will be shared on request
Citations:
PubMed Identifier
31840285
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.
Results Reference
result

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Feasibility Trial of Getting Better Bite by Bite for Eating Disorders

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