title: Pilot randomised controlled trial of Help4Mood, an embodied virtual agent-based system to support treatment of depression.
abstract: BACKGROUND
  Help4Mood is an interactive system with an embodied virtual agent (avatar) to assist in self-monitoring of patients receiving treatment for depression. Help4Mood supports self-report and biometric monitoring and includes elements of cognitive behavioural therapy. We aimed to evaluate system use and acceptability, to explore likely recruitment and retention rates in a clinical trial and to obtain an estimate of potential treatment response with a view to conducting a future randomised controlled trial (RCT).
  
  
  METHODS
  We conducted a pilot RCT of Help4Mood in three centres, in Romania, Spain and Scotland, UK. Patients with diagnosed depression (major depressive disorder) and current mild/moderate depressive symptoms were randomised to use the system for four weeks in addition to treatment as usual (TAU) or to TAU alone.
  
  
  RESULTS
  Twenty-seven individuals were randomised and follow-up data were obtained from 21 participants (12/13 Help4Mood, 9/14 TAU). Half of participants randomised to Help4Mood used it regularly (more than 10 times); none used it every day. Acceptability varied between users. Some valued the emotional responsiveness of the system, while others found it too repetitive. Intention to treat analysis showed a small difference in change of Beck Depression Inventory II (BDI-2) scores (Help4Mood -5.7 points, TAU -4.2). Post-hoc on-treatment analysis suggested that participants who used Help4Mood regularly experienced a median change in BDI-2 of -8 points.
  
  
  CONCLUSIONS
  Help4Mood is acceptable to some patients receiving treatment for depression although none used it as regularly as intended. Changes in depression symptoms in individuals who used the system regularly reached potentially meaningful levels.
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, UK c.burton@abdn.ac.uk.
authors.forename: Christopher
authors.initials: C
authors.lastname: Burton
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Romania.
authors.forename: Aurora
authors.initials: A
authors.lastname: Szentagotai Tatar
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: McKinstry
authors.affiliation: School of Informatics, University of Edinburgh, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Matheson
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Romania.
authors.forename: Silviu
authors.initials: S
authors.lastname: Matu
authors.affiliation: Department of Psychology, Babes-Bolyai University, Romania.
authors.forename: Ramona
authors.initials: R
authors.lastname: Moldovan
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, UK.
authors.forename: Michele
authors.initials: M
authors.lastname: Macnab
authors.affiliation: School of Informatics, University of Edinburgh, UK.
authors.forename: Elaine
authors.initials: E
authors.lastname: Farrow
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Romania.
authors.forename: Daniel
authors.initials: D
authors.lastname: David
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, UK.
authors.forename: Claudia
authors.initials: C
authors.lastname: Pagliari
authors.affiliation: Parc Sanitari San Joan De Deu, Spain.
authors.forename: Antoni
authors.initials: A
authors.lastname: Serrano Blanco
authors.affiliation: School of Informatics, University of Edinburgh, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Wolters
mesh_terms: D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D020000:Decision Support Systems, Clinical; D003863:Depression / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012383:Romania; D012606:Scotland; D013030:Spain; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000379:methods*; D014584:User-Computer Interface; D055815:Young Adult
keywords: Ehealth; telehealth; telepsychiatry