Pilot randomised controlled trial of Help4Mood, an embodied virtual agent-based system to support treatment of depression
Open accessAbstract
Introduction: 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. Conclusion: 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.
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Only 1 study, a pilot RCT, recruited participants from clinician caseloads or registers.
“Only 1 study, a pilot RCT, recruited participants from clinician caseloads or registers [28].”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
Greater engagement with the conversational agent resulted in greater reductions in psychological distress.
“Generally, greater engagement with the conversational agent resulted in greater reductions in psychological distress [22,26,28,29,33].”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
The 2 uncontrolled studies and 2 studies that did not test for between-group effects reported reductions in depression and loneliness postintervention.
“Finally, the 2 uncontrolled studies included in the review [22,29] and 2 studies that did not test for between-group effects [28,30] reported reductions in depression [28-30] and loneliness [22] postintervention.”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
The only study that reported difficulties in recruiting participants relied on clinicians to refer patients to the study.
“Remarkably, the only study that reported difficulties in recruiting participants relied on clinicians to refer patients to the study [28].”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
Controlled studies with active control conditions failed to demonstrate superior effects.
“Controlled studies with active control conditions (eg, another conversational agent or human psychological therapy) failed to demonstrate superior effects [24,27,28].”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
Participants reported that they liked the ability to customize the gender and appearance of ECAs and the option to tailor the session length to their own needs.
“Participants reported that they liked the ability to customize the gender and appearance of ECAs [28] and the option to tailor the session length to their own needs [28].”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
The predominant challenges to intervention with a conversational agent included repetitive content, limitations in the agents ability to understand or respond appropriately, a shallow or superficial relationship, the sound and quality of the agents voice, and specific intervention tools or content.
“The predominant challenges to intervention with a conversational agent included repetitive content [22,25,26,28,29,33], limitations in the agents ability to understand or respond appropriately [22,25,26,29], a shallow or superficial relationship [28,33], the sound and quality of the agents voice [32], and specific intervention tools or content [25,29].”
From Conversational agents in the treatment of mental health problems: mixed-method systematic review (2019) · cites this paper as [28]
A randomized controlled trial evaluated Help4Mood with 28 depressed patients randomized into Help4Mood and TAU.
“A randomized controlled trial was conducted to evaluate Help4Mood [66]. Twenty-eight depressed patients were recruited and randomized into two treatment groups: Help4Mood and TAU.”
From Current state and future directions of technology-based ecological momentary assessment and intervention for major depressive disorder: a systematic review (2019) · cites this paper as [66]
Patients in the TAU group achieved greater clinical improvement compared to patients who used Help4Mood.
“patients in the TAU group achieved greater clinical improvement compared to patients who used the application”
From Current state and future directions of technology-based ecological momentary assessment and intervention for major depressive disorder: a systematic review (2019) · cites this paper as [66]
Regular Help4Mood users were more likely to obtain greater clinical improvement compared to users with low compliance.
“regular users were more likely to obtain greater clinical improvement compared to users with low compliance”
From Current state and future directions of technology-based ecological momentary assessment and intervention for major depressive disorder: a systematic review (2019) · cites this paper as [66]
Outcome measures BDI and QIDS-SR indicated reduced symptoms in both Help4Mood and TAU samples.
“Outcome measures, which included the Beck Depression Inventory (BDI) and Quick Inventory of Depressive Symptomatology—Self Report (QIDS-SR), indicated reduced symptoms in both samples.”
From Current state and future directions of technology-based ecological momentary assessment and intervention for major depressive disorder: a systematic review (2019) · cites this paper as [66]
Burton et al. (52) found that their embodied CA could serve as an adjunct for cognitive therapy.
“Burton et al. (52), for example, also found that their embodied CA could serve as an adjunct for cognitive therapy.”
From Computer-assisted avatar-based treatment for dysfunctional beliefs in depressive inpatients: A pilot study (2021) · cites this paper as [52]
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- Authors
- Burton, C., Szentagotai Tatar, A., McKinstry, B., Matheson, C., Matu, S., Moldovan, R., Macnab, M., Farrow, E., David, D., Pagliari, C., Serrano Blanco, A., Wolters, M., & for the Help4Mood Consortium
- Affiliations
- University of Aberdeen (GB)
- Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Romania
- University of Edinburgh (GB)
- Babeș-Bolyai University (RO)
- Parc Sanitari San Joan De Deu, Spain
- ORCID
- Venue
- Journal of Telemedicine and Telecare
- Publisher
- SAGE Publications
- Published
- 2016-07-09
- Volume
- 22
- Issue
- 6
- Pages
- 348-355
- ISSN
- 1357-633X (ISSN-L)
- 1758-1109
- OpenAlex
- W2184155438
- Cited by
- 125
- References
- 25
- Citations by year
- 2026: 11 · 2025: 17 · 2024: 19 · 2023: 23 · 2022: 13 · 2021: 7 · 2020: 11 · 2019: 12 · 2018: 4 · 2017: 8
- FWCI
- 6.51
- Type
- journal article
- Language
- en
- Open access
- Locations
- Journal of Telemedicine and Telecare (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Funders
- Engineering and Physical Sciences Research Council (EP/J017728/1, EP/J017728/2)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Social Psychology › Social Robot Interaction and HRI
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- depression, self-monitoring, cognitive behavioral therapy, major depressive disorder, treatment acceptability, system use, biometric monitoring, Beck Depression Inventory, digital mental health interventions
- MeSH terms
- Adolescent, Adult, Depression, Female, Humans, Male, Middle Aged, Pilot Projects, Psychiatric Status Rating Scales, Surveys and Questionnaires, Romania, Scotland, Spain, User-Computer Interface, Cognitive Behavioral Therapy, Patient Satisfaction, Telemedicine, Decision Support Systems, Clinical, Young Adult
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