Evaluation of a Program for Eating Disorders That Combines Cognitive-behavioral Therapy With Online Psychological Treatment

Summary

The purpose of this project is to conduct a multicentre, randomized controlled trial (RCT) with 250 patients diagnosed with an eating disorder (ED). In this experiment, the patients from the experimental group will test an mHealth application (TCApp developed by HealthApp) and then, a clinical efficacy analysis and economic evaluations will be performed. To do this, we have set the following three specific objectives:

* To evaluate the clinical efficacy of an intensive intervention that includes both standard face-to-face Cognitive Behavioural Treatment (CBT) (treatment as usual, TAU) plus an online intervention using TCApp, versus TAU alone.
* To carry out an economic evaluation (cost-utility and cost-effectiveness analysis) of the new mHealth intervention and identify factors that promote or hinder the implementation of TCApp in mental health settings in Spain.
* To analyse the adoption processes of this type of applications by patients and health professionals and identify the determinants of mHealth adoption.

General hypothesis:

The implementation of the intensive intervention program (TAU + TCApp) would result in a more significant improvement of the ED symptoms compared to the TAU control group.

Specific hypotheses:

* The application of the intensive mHealth intervention would lead to significantly greater change scores (difference between T0 and T1) in the primary outcome variable of ED psychopathology, compared to the control group.
* The mHealth intervention would lead to significantly greater change scores (difference between T0 and T1) in patients' secondary outcome variables: a) depression symptoms, b) anxiety symptoms, c) motivation to change, d) suicidal risk, and e) quality of life, compared to the control group.
* Similarly, intensive intervention would result in greater change scores (difference between T0 and T1) in caregivers' variables: a) quality of life and b) caregiver burden.

Conditions

• mHealth
• Eating Disorder

Interventions

BEHAVIORAL

TCApp

During these 12 weeks, in addition to TAU, the patient from the experimental group should use TCApp at least once a day, completing at least one self-record daily and/or contacting his/her therapist via chat when needed. The therapist responsible for the online monitoring should, at least once a week, connect to the online platform and perform the following actions: follow the patient's daily self-records, generate personalized reports or graphs and communicate with him/her via chat. After a 12-week period, patients from the experimental group and their therapists will stop using the TCApp application (they will be discharged).

BEHAVIORAL

TAU

The TAU control group will receive treatment as usual, that is to say, the standard face-to-face CBT, offered by the different ED units in Spain.

Sponsors & Collaborators

• La Caixa Foundation

  collaborator OTHER

• Universitat Oberta de Catalunya

  lead OTHER

Principal Investigators

• Francisco Lupiañez Villanueva, PhD · Universitat Oberta de Catalunya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-04

Primary Completion

2018-09-07

Completion

2018-09-07

Countries

• Spain

Study Locations