A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Eating Disorders Program, Boston University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Text-Message Intervention
Participants will undergo four weeks (in a randomized order) of receiving personalized motivational text-messages while receiving CBT for their eating disorder.
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No Intervention: No Text Message Phase
Participants will receive 4 randomized weeks of not receiving text messages while receiving CBT for their eating disorder.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Motivation to Change Eating Disorder Behaviors
Time Frame: Daily for 8 weeks
|
Daily for 8 weeks
|
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Change in Eating Disorder Symptoms
Time Frame: Daily for 8 weeks
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Daily for 8 weeks
|
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Kilocalorie Intake (measured by self-report food records)
Time Frame: Daily for 8 weeks
|
Daily for 8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility measured by compliance with daily questionnaire
Time Frame: 8 weeks
|
8 weeks
|
|
Acceptability measured by self-report ratings
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Rebecca Shingleton, M.A., Boston University Charles River Campus
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- F31MH097308 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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