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Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression

RecruitingNAAges 18 Years - 74 YearsAllHospital Universitari Vall d'Hebron Research Inst…
NCT07422519 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 reduct

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Presence of any contraindication to esketamine administration according to the approved product label * 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
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What it tests

  • Virtual-Reality-based mindfulness intervention
  • Esketamine Treatment as Usual (ESK)
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Where

1 site
Hospital Universitari Vall d'Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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