NCT02076854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 15, 2016

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 18, 2014

Last Update Submit

January 14, 2016

Conditions

Eating Disorders

Keywords

eating disordersanorexia nervosatreatmenttechnology

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Feasibility measured by compliance with daily questionnaire

    8 weeks

  • Acceptability measured by self-report ratings

    8 weeks

Study Arms (2)

Text-Message Intervention

EXPERIMENTAL

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 Text Message Phase

NO INTERVENTION

Participants will receive 4 randomized weeks of not receiving text messages while receiving CBT for their eating disorder.

Interventions

Text-Message InterventionBEHAVIORAL
Text-Message Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anorexia nervosa/subthreshold anorexia nervosa (i.e., individuals who exhibit significant dietary restraint)
  • + years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Disorders Program, Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

March 4, 2014

Study Start

October 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 15, 2016

Record last verified: 2014-02

Locations

US(1)