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

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ClinicalTrials.gov Identifier: NCT03197519
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
La Caixa Foundation
Information provided by (Responsible Party):
Francisco Lupiáñez Villanueva, Universitat Oberta de Catalunya

Brief 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, which will be also maintained at follow-up, T2) 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, which will be also maintained at follow-up, T2) 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, which will be also maintained at follow-up, T2) in caregivers' variables: a) quality of life and b) caregiver burden.

Condition or disease Intervention/treatment Phase
mHealth Eating Disorder Behavioral: TCApp Behavioral: TAU Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Treatment Program for Eating Disorders That Combines Face-to-face Cognitive Behavioural Treatment With an Online Intervention Using the TCapp Application, Within the Framework of Broader Research Project Entitled mHealth: Challenges and Opportunities for Health Systems
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental group
The experimental group will receive treatment as usual, that is to say, the standard treatment based on CBT principles that is offered by the different ED units in Spain, plus an online intervention using TCApp for a period of 12 weeks.
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).
TAU control group
The TAU control group will receive treatment as usual, offered by the different ED units in Spain. Patients from the control group will be offered access to TCApp after a 6-month period.
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.



Primary Outcome Measures :
  1. Change in Eating Disorder symptomatology I (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on Eating Disorders Examination Questionnaire (EDE-Q) (Fairburn & Beglin, 1994; Fairburn, 2008)

  2. Change in Eating Disorder symptomatology II (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on Short Evaluation of Eating Disorders (SEED) (Bauer, Winn, Schmidt, & Kordy, 2005)


Secondary Outcome Measures :
  1. Change in Depression (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on Beck Depression Inventory-II (BDI-II) (Beck, Steer, Ball, & Renieri, 1996)

  2. Change in Anxiety (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on State-Trait Anxiety Inventory (STAI) (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)

  3. Change in Motivation to change (AN patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) (Rieger, Touyz, & Beumont, 2002)

  4. Change in Treatment drop-out (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline to 3 months and from baseline to 6 months in number of patients who dropout based on healthcare professional statements (Yes or No), using a phone interview

  5. Change in Suicide risk (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on Beck Hopelessness Scale (BHS) (Beck et al., 1974)

  6. Change in Suicide risk (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in healthcare professional total score on Suicide Intent Scale (SIS) (Beck et al., 1974)

  7. Change in Quality of life (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on EuroQoL-EQ-5D (Group EQ, 1990)

  8. Change in Motivation to change (BN/BED/OSFED patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on Bulimia Nervosa Stages of Change Questionnaire (BNSOCQ) (Martínez, Castro, Bigorra, Morer, Calvo, Vila, Toro, & Riegel, 2007)


Other Outcome Measures:
  1. Change in Caregiver burden (caregivers) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in caregiver total score on Experience of Caregiving Inventory (ECI) (Szmukler, Burgess, Herrman, Bloch, Benson, & Colusa, 1996)

  2. Change in Caregiver quality of life (caregivers) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in caregiver total score on EuroQoL-EQ-5D (Group EQ, 1990)

  3. Cost of mobile app development (TCApp) [ Time Frame: Baseline ]
    Technical staff responses, using a phone interview (cost-effectiveness analysis)

  4. Change in consumption of health resources, drugs consumption and school or work absenteeism (patients) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in patient total score on iMTA Questionnaire: Healthcare consumption, illness and work associated with psychiatric illness (TiC-P) (cost-effectiveness analysis)

  5. Change in consumption of health resources (patient) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment on the total number of visits with the ED specialist and with the emergency services based on the healthcare professional responses, using a phone interview (cost-effectiveness analysis)

  6. Change in the amount of work (healthcare professionals) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in the amount of working hours per day, also considering the pay rate per hour and the time dedicated to the online follow-up of each patient. This information will be collected through a phone interview (cost-effectiveness analysis)

  7. Usability (TCApp) [ Time Frame: 3 months ]
    ED specialist total score on System Usability Scale (SUS) (Broooke, 1986)

  8. Usability (TCApp) [ Time Frame: 3 months ]
    Patient total score on System Usability Scale (SUS) (Broooke, 1986)

  9. Satisfaction (TCApp) [ Time Frame: 3 months ]
    ED specialist total score on Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979)

  10. Satisfaction (TCApp) [ Time Frame: 3 months ]
    Patient total score on Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979)

  11. Cost of mobile app maintenance (TCApp) [ Time Frame: 3 months ]
    Technical staff responses, using a phone interview (cost-effectiveness analysis)

  12. Change in consumption of health resources, drugs consumption and work absenteeism (caregivers) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in caregiver total score on iMTA Questionnaire: Healthcare consumption, illness and work associated with psychiatric illness (TiC-P) (cost-effectiveness analysis)

  13. Change in consumption of drugs (patient) [ Time Frame: Baseline-3 months, Baseline-6 months ]
    Change from baseline assessment to 3 months assessment and from baseline assessment to 6 months assessment in the consumption of drugs, based on the healthcare professional responses, using a phone interview (cost-effectiveness analysis)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of an Eating or Feeding Disorder, based on: a) the Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-S-PL) (DSM-5 criteria) for minor patients or b) the Structural Clinical Interview for DSM-5 (SCID-5-RV) for adult patients. The diagnosis should be one of the following types: Anorexia Nervosa; Bulimia nervosa; Binge Eating Disorder; Other Specified Feeding or Eating Disorder: Atypical Anorexia Nervosa, Bulimia nervosa (of low frequency and/or limited duration), Binge-eating disorder (of low frequency and/or limited duration), purging disorder, night eating syndrome.
  • Treatment regimen: Day Hospital or Ambulatory treatment, regardless of the illness duration or the severity of the disorder
  • Treatment received by ED unit of reference: Standard Cognitive Behavioural Therapy
  • Understanding of Spanish, Catalan or English language, depending on the language option chosen by the participant for the TCApp
  • Minimal digital skills and availability of proper mobile phone for patients

Exclusion Criteria:

  • Age less than 12 years
  • Treatment regimen: Hospitalization
  • Diagnosis of psychosis
  • Intellectual disability
  • Have a mobile phone with a Windows Phone operating system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197519


Contacts
Contact: Dimitra Anastasiadou, PhD +34 934505274 danastasiadou@uoc.edu

Locations
Spain
Servei de Salut de les Illes Balears Not yet recruiting
Balearic Islands, Spain
Contact: Maria Carrera Ferrer       maria.carrera@ssib.es   
Hospital Sant Joan de Déu Recruiting
Barcelona, Spain
Contact: Eduardo Serrano Troncoso       eserrano@sjdhospitalbarcelona.org   
Hospital Sant Rafael Recruiting
Barcelona, Spain
Contact: Josefa Borras Crusat       jborras.hsrafael@hospitalarias.es   
Hospital Universitario Dexeus del grupo Quirónsalud de Barcelona Recruiting
Barcelona, Spain
Contact: Katarina Gunnard       katarinagunnard@gmail.com   
Institut de Trastors Alimentaris ITA Not yet recruiting
Barcelona, Spain
Contact: Antoni Grau       tgrau@itacat.com   
Hospital Parc Taulí Not yet recruiting
Sabadell, Spain
Contact: Jordi Torralbas Ortega       JTorralbas@tauli.cat   
Sponsors and Collaborators
Universitat Oberta de Catalunya
La Caixa Foundation
Investigators
Principal Investigator: Francisco Lupiañez Villanueva, PhD Universitat Oberta de Catalunya

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco Lupiáñez Villanueva, Associate Professor and Researcher at the Faculty of Information and Communication Sciences, Universitat Oberta de Catalunya
ClinicalTrials.gov Identifier: NCT03197519     History of Changes
Other Study ID Numbers: 2016ACUP 00056
TCApp.2017-01 ( Other Identifier: Protocol ID assigned when protocol was submitted for approval to the Ethics Committees of the participating hospitals )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francisco Lupiáñez Villanueva, Universitat Oberta de Catalunya:
mHealth
Eating Disorders
Randomised Controlled Trial
Cognitive Behavioural Therapy
cost effectiveness

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders