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

Not Applicable

Recruiting

• Conditions: Auditory Hallucinations; Schizophrenia
• Interventions: Behavioral: Virtual Reality-based Intervention employing Neurofeedback; Behavioral: Virtual Reality-based Intervention

• Registration Number: NCT06628323
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief Summary

The primary goal of this pilot study is to examine the feasibility and acceptability of augmenting a Virtual Reality-based intervention for treating auditory hallucinations in schizophrenia with electroencephalogram (EEG)-based neurofeedback.

The main questions it aims to answer are:

1. Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations?

2. Will VR-NF show indications of being more effective than Virtual Reality-based therapy alone in reducing the severity of auditory hallucinations, improving daily functioning, and enhancing quality of life?

Researchers will compare VR-NF to Virtual Reality-based therapy alone to evaluate therapy effectiveness.

Participants will be allocated to receive 8 sessions of either VR-NF or Virtual Reality-based therapy alone. All participants will undergo a thorough assessment at baseline, and at 12 weeks post-baseline.

Detailed Description

Auditory hallucinations represent some of the most frequent and debilitating symptoms in schizophrenia spectrum disorders (SSD), affecting up to 80 % of individuals with SSD. Despite receiving treatment with antipsychotic medication, nearly one-third of these individuals continue to experience psychotic symptoms.

Virtual Reality-based interventions have emerged to address the essential need for targeted and effective psychotherapeutic interventions for auditory hallucinations. A recent randomized controlled trial (RCT) has developed and tested a fully immersive Virtual Reality-based intervention, with preliminary results indicating that this approach is effective in mitigating the severity of auditory hallucinations.

The Neuro-VR study aims to improve the effectiveness of this Virtual Reality-based intervention by incorporating real-time EEG-based neurofeedback into the intervention. We expect that augmenting the VR-based intervention with EEG-based neurofeedback will improve both its tolerability and effectiveness by using individual neurophysiological responses to guide the intervention.

The primary objective of the pilot study is to evaluate whether the combination of Virtual Reality and EEG-based neurofeedback is a feasible and acceptable therapeutic approach for treating auditory hallucinations in SSD. A secondary objective is to investigate whether Virtual Reality combined with EEG-based neurofeedback provides indications of being superior to Virtual Reality alone in reducing severity of auditory hallucinations, improving daily functioning and enhancing quality of life in individuals with SSD.

If the pilot study is found successful it could pave the way for broader clinical trials to document the effect of augmenting Virtual Reality-based interventions with real-time feedback from neurophysiological responses. In the long run, this combined approach can be implemented in the mental health clinics to complement traditional treatments.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Status Verified: 2024-11
• Study Start: 2024-11-12
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Ability to give informed consent
2. Age of 18-65 years
3. Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29)
4. Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more)
5. Identification of at least one dominant voice
6. No changes in antipsychotic medications four weeks prior to inclusion in the project
7. No planned changes in antipsychotic medication in the 12 weeks following inclusion in the project
8. A command of Danish or English sufficient to engage in therapy

Exclusion Criteria

1. Rejecting informed consent
2. A diagnosis of organic brain disease
3. Intellectual disability (IQ ˂ 70)
4. A primary diagnosis of substance dependence hindering engaging in therapy
5. Hear voices in a language the therapist does not speak
6. Inability to tolerate the therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF)	Virtual Reality-based Intervention employing Neurofeedback	Participants in the experimental group undergo 7 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 therapy	Virtual Reality-based Intervention	Participants in the control group will be offered 7 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.

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability as assessed by recruitment rate	Recruitment rate is monitored throughout the study period (1 year)	Percentage of target sample (30 participants) recruited after 12 months from study start.
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate	Retention rates are monitored throughout the study period (1 year)	Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (8 sessions).
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group	At 12 weeks follow up	Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a Likert scale ranging from 1-10 with higher scoring indicating a higher level of satisfaction with therapy.

Secondary Outcome Measures

Name	Time	Method
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)	Baseline and at 12 weeks follow up	SAPS is an interviewer-administered instrument with 34 items measuring positive symptoms in schizophrenia. Each item is rated on a 6-point scale ranging from None (0) to Severe (5) with higher scoring reflecting greater severity of positive symptoms.
Severity of auditory hallucinations as assessed by The Psychotic Symptom Rating Scales, Auditory Hallucination subscale (PSYRATS-AH)	Baseline and at 12 weeks follow up	PSYRATS-AH is an interviewer-administered instrument with 11 items assessing characteristics of hallucinations: frequency; duration; location; loudness; beliefs about origin of voices; amount of negative content of voices; degree of negative content; amount of distress; intensity of distress; disruption and control.; Each item is rated on a 5-point scale (0-4) with higher scores reflecting greater severity of auditory hallucinations.; Additionally, an optional item measuring Number of Voices will be included.
Level of acceptance of and action in relation to the hallucinated voices as assessed by the Voices Acceptance and Action Scale (VAAS)	Baseline and at 12 weeks follow up	The VAAS is a self-report scale assessing level of acceptance of and action in relation to the hallucinated voices rated on a 5-point Likert scale ranging from 'Strongly Disagree' (1) to 'Strongly Agree' (5) with higher scores reflecting higher levels of acceptance and action in relation to the hallucinated voices.
Beliefs about voice power, voice intent and responding styles as assessed by the revised Beliefs about Voices Questionnaire (BAVQ-R)	Baseline and at 12 weeks follow up	The BAVQ-R is a self-report questionnaire assessing beliefs about hallucinated voices. Each item is rated on a 4-point scale ranging from Disagree (0), Unsure (1), Slightly agree (2), Strongly agree (3) with higher scores indicating greater endorsement of a belief.
Level of perceived power in relation to the hallucinated voice as assessed by the Voice Power Differential Scale (VPDS)	Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up	The VPDS is a self-report questionnaire with seven items rated on a 5-point scale (1-5) with a total score ranging from 7-35. Higher scores indicate that the voice is perceived to have greater power compared to the respondent.; At therapy sessions 1 and 8, the participants will be asked to complete the questionnaire focusing on the hallucinated voice they choose to focus on during therapy.
Responding styles to hallucinated voices as assessed by the Assertive Responding to Voices (Approve - Voices) questionnaire	Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up	The Assertive Responding to Voices (Approve - Voices) questionnaire comprises 15 items assessing different ways to respond to the hallucinated voices.; Scores range from 0-10 with higher scores indicating higher degree of the specific responding to voices.; At therapy sessions 1 and 8, the participants will be asked to complete the questionnaire focusing on the hallucinated voice they choose to focus on during therapy.
Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)	Baseline and at 12 weeks follow up	The PSP is an interviewer administered instrument assessing different domains of social and daily functioning: job/education, social relations, personal hygiene and aggressive behaviour.; A total score ranges from 1-100 with higher scores indicating a higher degree of functioning.
Social functioning as assessed by the Social Functioning Scale (SFS)	Baseline and at 12 weeks follow up	The SFS is a self-report instrument assessing social functioning among individuals with schizophrenia.; The instrument comprises seven domains: Social engagement/withdrawal, Interpersonal behaviour, Prosocial activities, Recreation, Independence-competence, Independence-performance and Employment/occupation.; The minimum raw score is 0 and maximum raw score is 223 with higher scoring indicating a higher level of functioning.

Trial Locations

Locations (1)

Copenhagen Research Center for Mental Health - CORE; 🇩🇰 Copenhagen, Hellerup, Denmark