Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depr… (NCT07422519) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
Spain30 participantsStarted 2025-09-18
Plain-language summary
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.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity in depressive symptoms as assessed by Montgomery-Åsberg Depression Rating Scale (MADRS)
Timeframe: Baseline (Week 0), Week 4 (end of the induction phase), Week 30 (end of the maintenance phase), and Week 54 (follow-up)
Trial details
NCT IDNCT07422519
SponsorHospital Universitari Vall d'Hebron Research Institute