Virtual reality mindfulness added to usual treatment for hard-to-treat depression
Tests virtual reality mindfulness alongside esketamine in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT07422519, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitari Vall d'Hebron Research Institute
- Trial code
- NCT07422519
- Record updated
- 27 February 2026
- Original description
The primary aim of this study is to evaluate the efficacy and tolerability of a combined Virtual Reality (VR)-based mindfulness intervention and pharmacological treatment compared with pharmacological treatment alone in reducing depressive symptoms in patients with Treatment-Resistant Depression (TRD).Read full original descriptionShow less
A Pilot Randomised Controlled Study Evaluating the Efficacy and Tolerability of Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
The primary aim of this study is to evaluate the efficacy and tolerability of a combined Virtual Reality (VR)-based mindfulness intervention and pharmacological treatment compared with pharmacological treatment alone in reducing depressive symptoms in patients with Treatment-Resistant Depression (TRD).
Secondary questions this study aims to address include:
1. Does the combined intervention lead to changes in inflammatory blood parameters compared with pharmacological treatment alone? 2. Does the addition of a VR-based mindfulness intervention prolong remission of depressive symptoms six months after treatment completion? 3. Is the combined treatment with mindfulness and esketamine well-tolerated, and how does its adverse effect profile compare with esketamine treatment alone? 4. Is there an association between changes in mindfulness trait levels, assessed using the FFMQ-SF, and reductions in depressive symptom severity?
Participants will be recruited from a Treatment-Resistant Depression Programme and randomly assigned to receive either VR-based mindfulness intervention in addition to treatment as usual or treatment as usual alone. The mindfulness intervention will last one month and include a total of 8 sessions. All participants will undergo comprehensive assessments at baseline and at predefined follow-up time points to evaluate clinical outcomes, inflammatory markers, tolerability, and remission duration.
Inclusion: Age between 18 and 74 years, inclusive; Diagnosis of treatment-resistant Major Depressive Disorder (MDD), single or recurrent episode, in accordance with DSM-5 diagnostic criteria; Inadequate response to two or more oral antidepressants during the current depressive episode; Inadequate response to at least one pharmacological combination or augmentation strategy; Ability and willingness to provide written informed consent for participation and data collection.
Exclusion: Current participation in another interventional clinical study involving antidepressant medication; Any medical, psychiatric, or other condition that, in the opinion of the investigator, could: (a) compromise participant safety or well-being, or (b) interfere with, limit, or confound study assessments or outcomes; Presence of any contraindication to esketamine administration according to the approved product label.