A Feasibility Randomized Controlled Trial of Culturally Adapted Getting Better Bite-by-Bite (Ca-GBBB)Intervention for Individuals With Eating Disorders in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Intervention Log
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intervention Log
时间窗: During 4-month intervention period.
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
时间窗: From baseline to 4-month follow up
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
时间窗: From baseline to 4-month follow up
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.
Recruitment and attrition Logs
时间窗: One year's time
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).
次要结局
- Eating Disorder Examination Questionnaire(Change in score from baseline to 4-month follow-up)
- Beck Depression Inventory(Change in score from baseline to 4-month follow-up)
- Beck Scale for Suicidal Ideation(Change in score from baseline to 4-month follow-up)
- The Bulimic Investigatory Test, Edinburgh(Change in score from baseline to 4-month follow-up.)
- Kessler Psychological Distress Scale(Change in score from baseline to 4-month follow-up)
- Binge-Eating Disorder Screener(Change in score from baseline to 4-month follow-up)
- Oslo- 3 Social Support Scale(Change in score from baseline to 4-month follow-up)
- Client Satisfaction Questionnaire(Change in score from baseline to 4-month follow-up)
- The Sick, Control, One, Fat, Food(Change in score from baseline to 4-month follow-up)