A Randomized Controlled Pilot Trial of Low-resolution Brain Electromagnetic Tomography (LORETA) Neurofeedback Training for Treatment-resistant Auditory Verbal Hallucinations in Schizophrenia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- University of Dublin, Trinity College
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Rates of adverse psychiatric events
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Simon McCarthy-Jones
Associate Professor in Clinical Psychology and Neuropsychology
University of Dublin, Trinity College
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.
Outcomes
Primary Outcomes
Rates of adverse psychiatric events
Time Frame: 24 months
We will assess the proportion of patients entered into the trial who experienced adverse psychiatric events reported.
Drop-out rate: Controls
Time Frame: 24 months
We will measure the proportion of patients who were entered into the trial, randomised to the control condition, and dropped out of the study.
Willingness of participants to be randomised.
Time Frame: 24 months
We will measure the proportion of patients who were entered in the trial but refused randomisation.
Success of blinding of raters
Time Frame: 24 months
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.
Recruitment rate
Time Frame: 24 months
We will measure how many patients were recruited into the trial per calendar month of active recruitment.
Willingness of participants to complete assessments
Time Frame: 24 months
We will measure the proportion of participants who were entered into the trial and completed all baseline assessment measures.
Drop-out rate: LORETA condition
Time Frame: 24 months
We will measure the proportion of patients who were entered into the trial, randomised to the neurofeedback condition, and dropped out of the study.
Secondary Outcomes
- Delusions Subscale of the Psychotic Symptom Ratings (PSYRATS-D).(End of intervention (~4 months))
- Auditory Hallucinations Rating Scale (AHRS)(End of intervention (~4 months))
- Hospital Anxiety and Depression scale(End of intervention (~4 months))
- Auditory Hallucination Subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH)(End of intervention (~4 months))
- Quality of Life Enjoyment and Satisfaction Questionnaire(End of intervention (~4 months))