EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

University of Dublin, Trinity College4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Schizophrenia

Interventions

LORETAOTHER

Twenty sessions of neurofeedback training using LORETA in combination with z-scores.

Treatment as usualOTHER

Treatment-as-usual

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tallaght University Hospital / St. James' Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

Recruitment rate

We will measure how many patients were recruited into the trial per calendar month of active recruitment.

Time frame: 24 months

Willingness of participants to be randomised.

We will measure the proportion of patients who were entered in the trial but refused randomisation.

Time frame: 24 months

Willingness of participants to complete assessments

We will measure the proportion of participants who were entered into the trial and completed all baseline assessment measures.

Time frame: 24 months

Drop-out rate: LORETA condition

We will measure the proportion of patients who were entered into the trial, randomised to the neurofeedback condition, and dropped out of the study.

Time frame: 24 months

Success of blinding of raters

We will measure the proportion of blind raters who were correctly able to guess the group allocation of participants, and assess if this was greater than chance.

Time frame: 24 months

Rates of adverse psychiatric events

We will assess the proportion of patients entered into the trial who experienced adverse psychiatric events reported.

Time frame: 24 months

Drop-out rate: Controls

We will measure the proportion of patients who were entered into the trial, randomised to the control condition, and dropped out of the study.

Time frame: 24 months

Secondary Outcomes

Data from ClinicalTrials.gov

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Auditory Hallucination Subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH)

The Auditory Hallucination Subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH; Haddock et al., 1999) is an 11-item measure of the severity of auditory verbal hallucinations. Total scores can range from 0 to 44 with higher scores indicating greater severity of auditory verbal hallucinations. The PSYRATS-AH has been found to have a four-factor structure (Woodward et al., 2014). These are Emotion (range 0-20), Physical (range 0-12), Cognitive (range 0-8) and Loudness (range 0-4). Higher scores on each of these subscales represents more severe auditory verbal hallucinations. We will assess between group differences in both the total and four factor scores of the PSYRATS-AH at end of therapy.