App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

March 2, 2023 updated by: Margaret Sala, Yeshiva University

Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461-1915
        • Recruiting
        • Margaret Sala
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindful Courage
Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices.
Behavioral: Mindful Courage
Self-guided online intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 8-week treatment period
Module completion, ranging from 0 to 100%
8-week treatment period
Acceptability dimensions
Time Frame: 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, , with higher scores indicating better acceptability.
8-week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eating Disorder Symptoms
Time Frame: Baseline to post-treatment (8-weeks) and 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.
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Change in Emotion Dysregulation
Time Frame: Baseline to post-treatment (8-weeks) and 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
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Change in Body Dissatisfaction
Time Frame: Baseline to post-treatment (8-weeks) and 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.
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Savoring Beliefs
Time Frame: Baseline to post-treatment(8-weeks) and 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.
Baseline to post-treatment(8-weeks) and through 2-month follow-up
Psychosocial Impairment
Time Frame: Baseline to post-treatment (8-weeks) and 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.
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Change in Mindfulness
Time Frame: Baseline to post-treatment (8-weeks) and 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.
Baseline to post-treatment (8-weeks) and through 2-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeshiva University

Collaborators

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20204635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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