Trial · NCT07422519
Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
NCT07422519, Not applicable, Recruiting, Hospital Universitari Vall d'Hebron Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression. Trials, record NCT07422519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07422519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
- NCT number
- NCT07422519
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Conditions
- Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic, Treatment-Resistant Major Depressive Disorder
- Interventions
- Virtual-Reality-based mindfulness intervention, Esketamine Treatment as Usual (ESK)
- First posted
- 2026-02-20
- Last updated
- 2026-02-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity in depressive symptoms as assessed by Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline (Week 0), Week 4 (end of the induction phase), Week 30 (end of the maintenance phase), and Week 54 (follow-up) | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to evaluate the severity of depressive symptoms. Each item is scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. |
| Secondary | Clinical Global Impressions - Improvement (CGI-I) and Severity (CGI-S) | Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up) | The CGI-S is a single-item, clinician-rated measure of the clinician's assessment of the patient's current illness severity relative to the clinician's total experience with patients with the same condition. The CGI-S is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-I is a single-item, clinician-rated measure evaluating change in the patient's condition relative to baseline. The CGI-I is rated on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. Lower scores indicate greater improvement. |
| Secondary | Self-reported depressive symptoms as assessed by the Beck Depression Inventory (BDI) | Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up) | The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire designed to measure the severity of depressive symptoms, with total scores ranging from 0 to 63. Scores are calculated by summing the 0-3 ratings for each item, where higher scores indicate greater severity. |
| Secondary | Global functioning as assessed by Global Assessment of Functioning (GAF) | Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up) | The Global Assessment of Functioning (GAF) scale is a 0-100 numerical rating assessing a person's overall psychological, social, and occupational functioning. It measures how symptoms affect daily life, with higher scores indicating better functioning and lower scores indicating severe impairment. |
| Secondary | Functional impairment as assessed by Sheehan Disability Scale (SDS) | Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up) | The Sheehan Disability Scale (SDS) is a self-rated, 3-item questionnaire assessing functional impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is rated on a 10-point visual analogue scale ranging from 0 = no impairment to 10 = extreme impairment, yielding a total score ranging from 0 to 30, with higher scores indicating greater functional impairment. |
| Secondary | Dissociative symptoms as assessed by the Clinician-Administered Dissociative States Scale (CADSS) | During the induction phase, approximately 1.5 hours after each dose, through Week 4 (end of induction phase). | The Clinician-Administered Dissociative States Scale (CADSS) is a clinician-administered scale designed to measure present-state dissociative symptoms. The scale includes 23 items, each rated from 0 = not at all to 4 = extremely. Item scores are summed to yield a total score ranging from 0 to 92, with higher scores indicating greater dissociative symptom severity. |
| Secondary | Mindfulness trait levels as assessed by Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) | Baseline (Week 0), Week 4 (end of the induction phase) | The FFMQ-SF is a self-report instrument that assesses five domains of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging of Inner Experience, and Nonreactivity to Inner Experience. The short form consists of 24 items, each rated on a 5-point Likert scale ranging from 1 = never or very rarely true to 5 = very often or always true. Item scores are summed to yield a total score, with higher scores indicating greater levels of trait mindfulness. |
| Secondary | The incidence of adverse events | Throughout the study period (up to Week 30) | Treatment tolerability and safety as assessed by the incidence, nature, and severity of adverse events, including treatment-emergent adverse events (TEAEs). |
| Other | Treatment resistance severity assessed by Maudsley Staging Method (MSM) | Baseline (Week 0) | The Maudsley Staging Method (MSM) is a clinician-rated instrument used to quantify the degree of treatment resistance in major depressive disorder. The scale incorporates three domains: (1) duration of the current depressive episode, (2) symptom severity, and (3) history of antidepressant treatment failures, including adequacy of dose and duration. Domain scores are combined to generate a total score, with higher scores indicating greater treatment resistance. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07422519
GET https://conductscience.org/api/trials/v1/NCT07422519/registered