Back to resultsA Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa
Primary Purpose
Eating Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text-Message Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring eating disorders, anorexia nervosa, treatment, technology
Eligibility Criteria
Inclusion Criteria:
- Anorexia nervosa/subthreshold anorexia nervosa (i.e., individuals who exhibit significant dietary restraint)
- 18+ years old
Exclusion Criteria:
- BMI < 16.5
- Medication instability for 6 weeks
- Recent/current suicidal risk
- Comorbid substance abuse or dependence, bipolar disorder, schizophrenia, or mental retardation
- Inability to provide release of information to a medical provider
Sites / Locations
- Eating Disorders Program, Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Text-Message Intervention
No Text Message Phase
Arm Description
Participants will undergo four weeks (in a randomized order) of receiving personalized motivational text-messages while receiving CBT for their eating disorder.
Participants will receive 4 randomized weeks of not receiving text messages while receiving CBT for their eating disorder.
Outcomes
Primary Outcome Measures
Change in Motivation to Change Eating Disorder Behaviors
Change in Eating Disorder Symptoms
Kilocalorie Intake (measured by self-report food records)
Secondary Outcome Measures
Feasibility measured by compliance with daily questionnaire
Acceptability measured by self-report ratings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02076854
Brief Title
A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to pilot an innovative motivational text-message intervention for individuals with anorexia nervosa and subthreshold anorexia nervosa. Patients will receive personalized motivational text-messages as an adjunct to cognitive behavioral therapy (CBT). CBT will be provided to patients at no cost for the duration of the study. The investigators hypothesize that the text-messages will help increase motivation to change and kilocalorie intake and decrease eating disordered behavior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
eating disorders, anorexia nervosa, treatment, technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text-Message Intervention
Arm Type
Experimental
Arm Description
Participants will undergo four weeks (in a randomized order) of receiving personalized motivational text-messages while receiving CBT for their eating disorder.
Arm Title
No Text Message Phase
Arm Type
No Intervention
Arm Description
Participants will receive 4 randomized weeks of not receiving text messages while receiving CBT for their eating disorder.
Intervention Type
Behavioral
Intervention Name(s)
Text-Message Intervention
Primary Outcome Measure Information:
Title
Change in Motivation to Change Eating Disorder Behaviors
Time Frame
Daily for 8 weeks
Title
Change in Eating Disorder Symptoms
Time Frame
Daily for 8 weeks
Title
Kilocalorie Intake (measured by self-report food records)
Time Frame
Daily for 8 weeks
Secondary Outcome Measure Information:
Title
Feasibility measured by compliance with daily questionnaire
Time Frame
8 weeks
Title
Acceptability measured by self-report ratings
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anorexia nervosa/subthreshold anorexia nervosa (i.e., individuals who exhibit significant dietary restraint)
18+ years old
Exclusion Criteria:
BMI < 16.5
Medication instability for 6 weeks
Recent/current suicidal risk
Comorbid substance abuse or dependence, bipolar disorder, schizophrenia, or mental retardation
Inability to provide release of information to a medical provider
Facility Information:
Facility Name
Eating Disorders Program, Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
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A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa
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