A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT02076854

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders	Behavioral: Text-Message Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Motivation to Change Eating Disorder Behaviors [Daily for 8 weeks]
Change in Eating Disorder Symptoms [Daily for 8 weeks]
Kilocalorie Intake (measured by self-report food records) [Daily for 8 weeks]

Secondary Outcome Measures

Feasibility measured by compliance with daily questionnaire [8 weeks]
Acceptability measured by self-report ratings [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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