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

NCT03197519 | Completed

• 2 other identifiers: 2016ACUP 00056TCApp.2017-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

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) 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

Keywords

mHealth; Eating Disorders; Randomised Controlled Trial; Cognitive Behavioural Therapy; cost effectiveness

Outcome Measures

Primary Outcomes (2)

• Change in Eating Disorder symptomatology I (patients)

  Change from baseline assessment to 3 months assessment

  Baseline-3 months

• Change in Eating Disorder symptomatology II (patients)

  Change from baseline assessment to 3 months assessment in patient total score on Short Evaluation of Eating Disorders (SEED) (Bauer, Winn, Schmidt, \& Kordy, 2005)

  Baseline-3 months

Secondary Outcomes (7)

• Change in Depression (patients)

  Baseline-3 months

• Change in Anxiety (patients)

  Baseline-3 months

• Change in Motivation to change (AN patients)

  Baseline-3 months

• Change in Treatment drop-out (patients)

  Baseline-3 months

• Change in Suicide risk (patients)

  Baseline-3 months

Other Outcomes (13)

• Change in Caregiver burden (caregivers)

  Baseline-3 months

• Change in Caregiver quality of life (caregivers)

  Baseline-3 months

• Cost of mobile app development (TCApp)

  Baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

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

TAU control group

OTHER

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

Interventions

TCApp BEHAVIORAL

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).

Experimental group

TAU BEHAVIORAL

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.

TAU control group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Oberta de Catalunya: lead
• La Caixa Foundation: collaborator

Study Sites (4)

Hospital Sant Joan de Déu

Barcelona, Spain

Location

Hospital Universitario Dexeus del grupo Quirónsalud de Barcelona

Barcelona, Spain

Location

Servei de Salut de les Illes Balears

Palma de Mallorca, Spain

Location

Hospital Parc Taulí

Sabadell, Spain

Location

Related Publications (16)

• Stuhldreher N, Konnopka A, Wild B, Herzog W, Zipfel S, Lowe B, Konig HH. Cost-of-illness studies and cost-effectiveness analyses in eating disorders: a systematic review. Int J Eat Disord. 2012 May;45(4):476-91. doi: 10.1002/eat.20977. Epub 2012 Feb 1.

  PMID: 22294558 BACKGROUND

• Steinhausen HC. The outcome of anorexia nervosa in the 20th century. Am J Psychiatry. 2002 Aug;159(8):1284-93. doi: 10.1176/appi.ajp.159.8.1284.

  PMID: 12153817 BACKGROUND

• Anastasiadou D, Medina-Pradas C, Sepulveda AR, Treasure J. A systematic review of family caregiving in eating disorders. Eat Behav. 2014 Aug;15(3):464-77. doi: 10.1016/j.eatbeh.2014.06.001. Epub 2014 Jun 19.

  PMID: 25064301 BACKGROUND

• Fairburn CG, Rothwell ER. Apps and eating disorders: A systematic clinical appraisal. Int J Eat Disord. 2015 Nov;48(7):1038-46. doi: 10.1002/eat.22398. Epub 2015 Feb 27.

  PMID: 25728705 BACKGROUND

• Bauer S, Moessner M. Harnessing the power of technology for the treatment and prevention of eating disorders. Int J Eat Disord. 2013 Jul;46(5):508-15. doi: 10.1002/eat.22109.

  PMID: 23658102 BACKGROUND

• Loucas CE, Fairburn CG, Whittington C, Pennant ME, Stockton S, Kendall T. E-therapy in the treatment and prevention of eating disorders: A systematic review and meta-analysis. Behav Res Ther. 2014 Dec;63:122-31. doi: 10.1016/j.brat.2014.09.011. Epub 2014 Oct 5.

  PMID: 25461787 BACKGROUND

• Jacobi C, Volker U, Trockel MT, Taylor CB. Effects of an Internet-based intervention for subthreshold eating disorders: a randomized controlled trial. Behav Res Ther. 2012 Feb;50(2):93-9. doi: 10.1016/j.brat.2011.09.013. Epub 2011 Nov 15.

  PMID: 22137366 BACKGROUND

• Kass AE, Trockel M, Safer DL, Sinton MM, Cunning D, Rizk MT, Genkin BH, Weisman HL, Bailey JO, Jacobi C, Wilfley DE, Taylor CB. Internet-based preventive intervention for reducing eating disorder risk: A randomized controlled trial comparing guided with unguided self-help. Behav Res Ther. 2014 Dec;63:90-8. doi: 10.1016/j.brat.2014.09.010. Epub 2014 Oct 2.

  PMID: 25461783 BACKGROUND

• Stice E, Durant S, Rohde P, Shaw H. Effects of a prototype Internet dissonance-based eating disorder prevention program at 1- and 2-year follow-up. Health Psychol. 2014 Dec;33(12):1558-67. doi: 10.1037/hea0000090. Epub 2014 Jul 14.

  PMID: 25020152 BACKGROUND

• Aardoom JJ, Dingemans AE, Spinhoven P, Van Furth EF. Treating eating disorders over the internet: a systematic review and future research directions. Int J Eat Disord. 2013 Sep;46(6):539-52. doi: 10.1002/eat.22135. Epub 2013 May 15.

  PMID: 23674367 BACKGROUND

• Schlegl S, Burger C, Schmidt L, Herbst N, Voderholzer U. The potential of technology-based psychological interventions for anorexia and bulimia nervosa: a systematic review and recommendations for future research. J Med Internet Res. 2015 Mar 31;17(3):e85. doi: 10.2196/jmir.3554.

  PMID: 25840591 BACKGROUND

• Juarascio AS, Manasse SM, Goldstein SP, Forman EM, Butryn ML. Review of smartphone applications for the treatment of eating disorders. Eur Eat Disord Rev. 2015 Jan;23(1):1-11. doi: 10.1002/erv.2327. Epub 2014 Oct 10.

  PMID: 25303148 BACKGROUND

• Nitsch M, Dimopoulos CN, Flaschberger E, Saffran K, Kruger JF, Garlock L, Wilfley DE, Taylor CB, Jones M. A Guided Online and Mobile Self-Help Program for Individuals With Eating Disorders: An Iterative Engagement and Usability Study. J Med Internet Res. 2016 Jan 11;18(1):e7. doi: 10.2196/jmir.4972.

  PMID: 26753539 BACKGROUND

• Tregarthen JP, Lock J, Darcy AM. Development of a smartphone application for eating disorder self-monitoring. Int J Eat Disord. 2015 Nov;48(7):972-82. doi: 10.1002/eat.22386. Epub 2015 Jul 27.

  PMID: 26213130 BACKGROUND

• Juarascio AS, Goldstein SP, Manasse SM, Forman EM, Butryn ML. Perceptions of the feasibility and acceptability of a smartphone application for the treatment of binge eating disorders: Qualitative feedback from a user population and clinicians. Int J Med Inform. 2015 Oct;84(10):808-16. doi: 10.1016/j.ijmedinf.2015.06.004. Epub 2015 Jun 15.

  PMID: 26113461 BACKGROUND

• Anastasiadou D, Lupianez-Villanueva F, Fauli C, Arcal Cunillera J, Serrano-Troncoso E. Cost-effectiveness of the mobile application TCApp combined with face-to-face CBT treatment compared to face-to-face CBT treatment alone for patients with an eating disorder: study protocol of a multi-centre randomised controlled trial. BMC Psychiatry. 2018 May 2;18(1):118. doi: 10.1186/s12888-018-1664-4.

  PMID: 29716580 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Francisco Lupiañez Villanueva, PhD

  Universitat Oberta de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Researcher at the Faculty of Information and Communication Sciences

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 23, 2017
• Study Start: September 4, 2017
• Primary Completion: September 7, 2018
• Study Completion: September 7, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)