Clinical trial NCT03852706: EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)
Official title: A Randomized Controlled Pilot Trial of Low-resolution Brain Electromagnetic Tomography (LORETA) Neurofeedback Training for Treatment-resistant Auditory Verbal Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Hallucinations
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Actualise
First posted: 2019-02-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study's primary objective is to perform a randomized controlled pilot study to assess the feasibility of using EEG-based neurofeedback to reduce the severity of treatment-resistant auditory verbal hallucinations ('hearing voices') in patients diagnosed with schizophrenia. Patients will be randomized to receive either EEG-based neurofeedback or treatment-as-usual.

Detailed description: Auditory verbal hallucinations (AVH) are experienced by up to 80% of patients diagnosed with schizophrenia, where they can cause significant occupational and social impairment. Current treatments are incompletely effective. Around 25-30% of AVH are refractory to antipsychotic drugs, and cognitive behavioural therapy only shows a small-medium effect size. Initially promising studies of neurostimulation have shown smaller effect sizes as better controlled trials have been conducted. There is hence the need for innovative new treatments. One potential option is neurofeedback training. The primary objective of study is to perform a randomized, controlled, rater-blinded pilot trial (n=40) of EEG neurofeedback for AVH in patients with treatment-resistant schizophrenia, to assess trial process, which will then inform a future definitive trial. The secondary objective is to calculate a 95% confidence interval that will allow interpretation of statistical difference between neurofeedback and treatment-as-usual groups to assess neurofeedback for reducing auditory verbal hallucinations. Participants will be randomly allocated to either a neurofeedback (plus treatment-as-usual) or treatment-as-usual alone condition. Neurofeedback will employ Z-score based LORETA (Low Resolution Brain Electromagnetic Tomography). After a baseline assessment, twenty sessions of personalized neurofeedback training will be delivered over a period of approximately four months. This is the first registered trial of EEG neurofeedback for hallucinations. The primary focus of the pilot trial is on feasibility. However, a 95% confidence interval will be determined for the difference on PSYRATS-AH and AHRS scores between neurofeedback and treatment-as-usual to help inform a future definitive trial.

Eligibility criteria: Inclusion Criteria:

* Are ≥ 18 years old
* Have a clinical diagnosis of a schizophrenia-spectrum disorder
* Have been experiencing auditory verbal hallucinations for at least one year
* Score 2 or more on the frequency item of the auditory hallucinations subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH; Haddock et al., 1999) at time of initial assessment (representing voices occurring at least once a day)
* Are deemed refractory to antipsychotic treatment (defined as still hearing voices despite 4-6 weeks of treatment with two different antipsychotics)
* Have been on a stable dose of antipsychotic medication for the three months prior to study enrolment
* Are right-handed, as determined by the Edinburgh Handedness Inventory (Oldfield, 1971)
* Are able to provide written, informed consent.

Exclusion Criteria:

* Having a diagnosed substance abuse disorder
* Prior head injury with loss of consciousness for more than five minutes
* At immediate risk of harm to self or others.

Primary outcomes:
measure: Recruitment rate
timeFrame: 24 months
measure: Willingness of participants to be randomised.
timeFrame: 24 months
measure: Willingness of participants to complete assessments
timeFrame: 24 months
measure: Drop-out rate: LORETA condition
timeFrame: 24 months
measure: Success of blinding of raters
timeFrame: 24 months
measure: Rates of adverse psychiatric events
timeFrame: 24 months
measure: Drop-out rate: Controls
timeFrame: 24 months
Secondary outcomes:
measure: Auditory Hallucination Subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH)
timeFrame: End of intervention (~4 months)
measure: Auditory Hallucinations Rating Scale (AHRS)
timeFrame: End of intervention (~4 months)
measure: Delusions Subscale of the Psychotic Symptom Ratings (PSYRATS-D).
timeFrame: End of intervention (~4 months)
measure: Hospital Anxiety and Depression scale
timeFrame: End of intervention (~4 months)
measure: Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: End of intervention (~4 months)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Tallaght University Hospital / St. James' Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Simon McCarthy-Jones
role: PRINCIPAL_INVESTIGATOR
References: