Binge Eating Disorder
Conditions
Keywords
binge eating, eating disorders, obesity
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALMeditation-enhanced Cognitive Behavioral Therapy
Self-guided online intervention
Sponsors
Yeshiva University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Meeting DSM-5 criteria for Binge Eating Disorder (BED) * English-speaking
Exclusion criteria
* BMI \< 18.5 * Requiring immediate treatment for medical complications * Current anorexia or bulimia nervosa or purging behaviors within the past year * Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed) * Currently pregnant or breast-feeding * Experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active psychotic disorder, cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility/Completion | 18-week treatment period | Module completion, ranging from 0 to 100% |
| Acceptability | 18-week treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Emotion Dysregulation | Baseline to post-treatment (18-weeks) | 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 |
| Changes in Mindfulness | Baseline to post-treatment (18-weeks) | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness. |
| Changes in Objective Binge Eating Episodes | Baseline to post-treatment (18-weeks) | 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. |
| Changes in Quality of Life | Baseline to post-treatment (18-weeks) | 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. |
| Change in Body Mass Index (BMI) | Baseline to post-treatment (18-weeks) | Computed using self-reported height and body weight |
| Changes in Depression Symptoms | Baseline to post-treatment (18-weeks) | Beck Depression Inventory-II (BDI-II; Beck et al., 1996). Scores range from 0 to 63, with higher scores indicating higher depression symptoms. |
| Changes in Dietary Restraint | Baseline to post-treatment (18-weeks) | Dietary restraint subscale of the EDE-Q (EDE-Q; Fairburn \&amp;amp; Beglin, 1994). Scores range from 0 to 6, and higher scores indicate higher restraint. |
Countries
United States
Outcome results
None listed