A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa

January 14, 2016 updated by: Boston University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Eating Disorders Program, Boston University

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:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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.
Behavioral: Text-Message Intervention
No Intervention: No Text Message Phase
Participants will receive 4 randomized weeks of not receiving text messages while receiving CBT for their eating disorder.

What is the study measuring?

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
Change in Eating Disorder Symptoms
Time Frame: Daily for 8 weeks
Daily for 8 weeks
Kilocalorie Intake (measured by self-report food records)
Time Frame: Daily for 8 weeks
Daily for 8 weeks

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

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

Sponsor

Boston 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

October 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F31MH097308 (U.S. NIH Grant/Contract)

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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