Clinical trial NCT05753410: App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Official title: Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Bulimia Nervosa
Anorexia Nervosa, Atypical
Bulimia; Atypical
Keywords: Anorexia Nervosa
Bulimia Nervosa
Mindfulness Training
Digital Intervention
Lead sponsor: Yeshiva University
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2023-03-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 8-week treatment period
measure: Acceptability dimensions
timeFrame: 8-week treatment period
Secondary outcomes:
measure: Change in Eating Disorder Symptoms
timeFrame: Baseline to post-treatment (8-weeks) and through 2-month follow-up
measure: Change in Emotion Dysregulation
timeFrame: Baseline to post-treatment (8-weeks) and through 2-month follow-up
measure: Change in Body Dissatisfaction
timeFrame: Baseline to post-treatment (8-weeks) and through 2-month follow-up
measure: Savoring Beliefs
timeFrame: Baseline to post-treatment(8-weeks) and through 2-month follow-up
measure: Psychosocial Impairment
timeFrame: Baseline to post-treatment (8-weeks) and through 2-month follow-up
measure: Change in Mindfulness
timeFrame: Baseline to post-treatment (8-weeks) and through 2-month follow-up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Margaret Sala
state: New York
Study officials:
References: