A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa

Eating Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076854
• Other study ID #: F31MH097308
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: January 14, 2016
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2014
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia Nervosa
• Eating Disorders

Intervention

Behavioral:
• Text-Message Intervention

Locations

Country	Name	City	State
United States	Eating Disorders Program, Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motivation to Change Eating Disorder Behaviors		Daily for 8 weeks	No
Primary	Change in Eating Disorder Symptoms		Daily for 8 weeks	No
Primary	Kilocalorie Intake (measured by self-report food records)		Daily for 8 weeks	No
Secondary	Feasibility measured by compliance with daily questionnaire		8 weeks	No
Secondary	Acceptability measured by self-report ratings		8 weeks	No