Anorexia Nervosa, Anorexia Nervosa, Atypical, Bulimia; Atypical, Bulimia Nervosa
Conditions
Keywords
Anorexia Nervosa, Bulimia Nervosa, Mindfulness Training, Digital Intervention
Brief summary
We will evaluate the acceptability and feasibility of a 8-week long digital mindfulness-based intervention for anorexia nervosa and bulimia nervosa. 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) brief daily assessments for the first and last weeks of the study (4 times per day); (3) an initial baseline visit; (4) 8-week web-based intervention (3) a post-intervention assessment (8-weeks after baseline); and (4) a brief 8-week follow-up assessment.
Interventions
BEHAVIORALMindful Courage
Self-guided online intervention
Sponsors
Yeshiva University
Yale University
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
* 18 years of age or older * Can read and write in English * Meet diagnostic DSM 5 diagnostic criteria for anorexia nervosa, bulimia nervosa, or atypical anorexia nervosa/bulimia nervosa * Owns a smartphone * Willing and able to participate in an eight-week long research study * Have a private quiet space at home or headphones to complete modules * Completed one month or more of eating disorder treatment * Currently enrolled in eating disorder treatment
Exclusion criteria
* Fail to meet above-listed inclusion criteria * Current alcohol or drug dependence * Current untreated psychotic or bipolar disorder * Current suicidal intent * Significant cognitive impairment that would impair the ability to use Mindful Courage effectively * BMI \<15 or medically unstable * Currently receiving residential/inpatient treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Module Completion | 8-week treatment period | Module completion, ranging from 0 to 100% |
| Acceptability Dimensions | 8-week treatment period | Single-items measuring ratings of acceptability dimensions, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills ratings. Scores for each item range from 1 to 5 and are averaged, with higher scores indicating better acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eating Disorder Symptoms | Baseline through 2-month follow-up | Eating Disorder Examination-Questionnaire (EDE-Q). Total scores are the average of each of the subscales, and range from 0 to 6. Higher scores indicate higher eating disorder symptoms. |
| Change in Emotion Dysregulation | Baseline through 2-month follow-up | 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 |
| Change in Body Dissatisfaction | Baseline through 2-month follow-up | Body Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction. |
| Savoring Beliefs | Baseline through 2-month follow-up | Savoring Beliefs Inventory (SBI). Total scores are the total across the positively-anchored and negatively-anchored items, and could range from -72 to 72. Higher scores reflect stronger endorsement of savoring beliefs. |
| Psychosocial Impairment | Baseline through 2-month follow-up | Clinical Impairment Assessment Questionnaire (CIA). Total scores are the total of the items, and range from 0 to 48. Higher scores indicate greater psychosocial impairment associated with an eating disorder. |
| Change in Mindfulness | Baseline through 2-month follow-up | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 28.8 years STANDARD_DEVIATION 7.8 |
| ED Diagnoses AN-BP | 3 Participants |
| ED Diagnoses AN-R | 6 Participants |
| ED Diagnoses Atypical AN | 11 Participants |
| ED Diagnoses Atypical BN | 5 Participants |
| ED Diagnoses BN | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex/Gender, Customized Sex Female | 21 Participants |
| Sex/Gender, Customized Sex Male | 7 Participants |
| Sex/Gender, Customized Sex Non-Binary | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
None listed