The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder. This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.
Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) 18-week web-based intervention; and (4) a post-intervention assessment (18-weeks after baseline).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Self-guided online intervention
Yeshiva University
The Bronx, New York, United States
Acceptability
Single-items measuring dimensions of acceptability, including overall satisfaction, engagement, visual appeal of content, understandability of program material, desire to continue the program, and overall helpfulness. Scores for each item range from 1 to 5, , with higher scores indicating better acceptability.
Time frame: 18-week treatment period
Feasibility/Completion
Module completion, ranging from 0 to 100%
Time frame: 18-week treatment period
Changes in Emotion Dysregulation
Difficulties in Emotion Regulation Short Form (DERS-SF). Total scores are the average of each of the subscales, and range from 1 to 5. Higher scores indicate more emotion dysregulation
Time frame: Baseline to post-treatment (18-weeks)
Changes in Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Time frame: Baseline to post-treatment (18-weeks)
Changes in Objective Binge Eating Episodes
Eating Disorder Examination-Questionnaire (EDE-Q). The EDE-Q asks participants to report on the number of episodes in the last 28 days in which they ate a large amount of food with a sense of loss of control.
Time frame: Baseline to post-treatment (18-weeks)
Change in Body Mass Index (BMI)
Computed using self-reported height and body weight
Time frame: Baseline to post-treatment (18-weeks)
Changes in Dietary Restraint
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Dietary restraint subscale of the EDE-Q (EDE-Q; Fairburn \& Beglin, 1994). Scores range from 0 to 6, and higher scores indicate higher restraint.
Time frame: Baseline to post-treatment (18-weeks)
Changes in Quality of Life
Eating Disorder Quality of Life scale (EDQOL; Engel et al., 1996). Scores on each item range from 1 to 4, with higher scores indicating better quality of life.
Time frame: Baseline to post-treatment (18-weeks)
Changes in Depression Symptoms
Beck Depression Inventory-II (BDI-II; Beck et al., 1996). Scores range from 0 to 63, with higher scores indicating higher depression symptoms.
Time frame: Baseline to post-treatment (18-weeks)