EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

NCT03852706 | Terminated DMC

• 2 other identifiers: 20678925911
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Hallucinations

Outcome Measures

Primary Outcomes (7)

• Recruitment rate

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

  24 months

• Willingness of participants to be randomised.

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

  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.

  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.

  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.

  24 months

• Rates of adverse psychiatric events

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

  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.

  24 months

Secondary Outcomes (5)

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

  End of intervention (~4 months)

• Auditory Hallucinations Rating Scale (AHRS)

  End of intervention (~4 months)

• Delusions Subscale of the Psychotic Symptom Ratings (PSYRATS-D).

  End of intervention (~4 months)

• Hospital Anxiety and Depression scale

  End of intervention (~4 months)

• Quality of Life Enjoyment and Satisfaction Questionnaire

  End of intervention (~4 months)

Study Arms (2)

LORETA

EXPERIMENTAL

In the first session, Low Resolution Brain Electromagnetic Tomography (LORETA) will be used in combination with Z-scores to identify participants' resting state EEG differences relative to a database of norms of their demographic. EEG abnormalities which are consistent with the research literature on neural changes associated with AVH will then be targeted for normalization using neurofeedback training using LORETA in combination with Z-scores.

Other: LORETA; Other: Treatment as usual

Treatment as usual

OTHER

Maintenance use of an atypical antipsychotic (e.g., clozapine) with support, when needed, of a community nurse.

Other: Treatment as usual

Interventions

LORETA OTHER

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

LORETA

Treatment as usual OTHER

Treatment-as-usual

LORETA; Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Actualise: collaborator

Study Sites (1)

Tallaght University Hospital / St. James' Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon McCarthy-Jones

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Clinical Psychology and Neuropsychology

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 25, 2019
• Study Start: March 1, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)