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Neuro-VRNCT06628323

Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations

StatusCompleted
PhaseNot applicable
Primary completion
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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of May 2026 to Apr 22, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary completion pushed from Mar 2026 to Apr 22, 2026
    • Study completion pushed from Mar 2026 to May 2026
    v6
  3. Lead sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital to University Hospital Bispebjerg and Frederiksbergv5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jan 2026 to Mar 2026
    • Site details revised
    • Study title revised
  4. Primary and study completion dates: Oct 2025 to Jan 2026v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Nov 12, 2024
    • Study site revised
    v3
  6. Secondary endpoints: details revised at 2 of 8 entriesv2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Feasibility and acceptability as assessed by recruitment rate
Timeframe: Recruitment rate is monitored throughout the study period (1 year)
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate
Timeframe: Retention rates are monitored throughout the study period (1 year)
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group
Timeframe: At 12 weeks follow up

Secondary (8)

Severity of positive symptoms (hallucinations, delusions, bizarre behavior and positive formal thought disorder) as assessed by the Scale for the Assessment of Positive Symptoms (SAPS)
Severity of auditory hallucinations as assessed by The Psychotic Symptom Rating Scales, Auditory Hallucination subscale (PSYRATS-AH)
Level of acceptance of and action in relation to the hallucinated voices as assessed by the Voices Acceptance and Action Scale (VAAS)
Beliefs about voice power, voice intent and responding styles as assessed by the revised Beliefs about Voices Questionnaire (BAVQ-R)
Level of perceived power in relation to the hallucinated voice as assessed by the Voice Power Differential Scale (VPDS)
Show 3 moreShow less
Responding styles to hallucinated voices as assessed by the Assertive Responding to Voices (Approve - Voices) questionnaire
Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)
Social functioning as assessed by the Social Functioning Scale (SFS)

Arms and interventions

Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF)Experimental

Participants in the experimental group undergo 8 sessions of a manualized virtual reality-based intervention added real-time EEG neurofeedback aiming to enhance the control and sense of power in relation to the dominant hallucinated voice. Together with the therapist, the participants create a digital representation (avatar) in virtual reality corresponding to the visual perception and sound of the voice. During therapy, the participants will be encouraged to engage in a dialogue with the avatar. While immersed in virtual reality, EEG recordings will be conducted by electrodes connected to a cap on the participants' head. Processed EEG-data will provide real-time information on the participants' brain activity associated with the emotional distress when confronted with the avatar and will be visible both to the participant and therapist. The feedback will be used to continuously adjust the intervention to the brain activity and aims to help the participant practice emotion regulation.

Virtual Reality - based therapyActive comparator

Participants in the control group will be offered 8 sessions of a manualized virtual reality - based therapy that follows the same principles as described in the experimental arm. Together with the therapist, the participants create a digital representation (avatar) in virtual reality that corresponds to their visual perception of and sounds like their hallucinated voice. Thoughout the therapy sessions, the participants will be encouraged to engage in a dialogue with the 'avatar', voiced by the therapist who will alternate between talking as the 'avatar' and as a supportive therapist. The therapy aims at enhancing the participants' control and feeling of power in relation to the dominant hallucinated voice. Furthermore, the therapy focuses on regulating the emotional distress associated with the hallucinated voice.

Behavioral: Virtual Reality-based Intervention employing Neurofeedback, Virtual Reality-based Intervention

Sites

1 site in 1 country

  • Copenhagen Research Center for Mental Health - CORECopenhagen, Hellerup, Denmark