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SchizophreniaHALFEEDNCT03852706

EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

A study testing LORETA and Treatment as usual in people with Schizophrenia, run by University of Dublin, Trinity College at 1 site in Ireland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
LORETA and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteIreland
Study dates
1 Mar 2019to 25 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Tallaght University Hospital / St. James' Hospital

    Dublin

Other trials in Ireland

About this study

Official title: A Randomized Controlled Pilot Trial of Low-resolution Brain Electromagnetic Tomography (LORETA) Neurofeedback Training for Treatment-resistant Auditory Verbal Hallucinations in Schizophrenia

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.

Read the 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.

Conditions
Schizophrenia
Being tested
LORETA, Treatment as usual
Keywords
Hallucinations
Medical subject headings
Schizophrenia, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LORETAOther

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

  • Treatment as usualOther

    Treatment-as-usual

Study groups in NCT03852706
Study groupRoleWhat they receive
LORETAExperimentalIn 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.
Receives: Other: LORETA; Other: Treatment as usual
Treatment as usualOtherMaintenance use of an atypical antipsychotic (e.g., clozapine) with support, when needed, of a community nurse.
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

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

    Measured: 24 months

  2. Willingness of participants to be randomised.

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

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: 24 months

  5. 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.

    Measured: 24 months

  6. Rates of adverse psychiatric events

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

    Measured: 24 months

  7. 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.

    Measured: 24 months

Secondary outcomes (5)

  1. 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.

    Measured: End of intervention (~4 months)

  2. Auditory Hallucinations Rating Scale (AHRS)

    The Auditory Hallucinations Rating Scale (AHRS; Hoffman et al., 2003) is a seven-item structured clinical interview, which assesses the severity of auditory verbal hallucinations in the past week. Its items assess frequency, reality, loudness, number, length, attentional salience (how demanding of attention the voice is) and distress level. Items are rated on unique scales. Total scores on this measure can range from 0 - 41 . Higher scores represent more severe auditory verbal hallucinations.

    Measured: End of intervention (~4 months)

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

    Delusions will be assessed by the Delusions Subscale of the Psychotic Symptom Ratings Scale (PSYRATS-D; Haddock et al., 1999). This is a 6-item structured clinical interview. Total scores can range from 0-24, with higher scores representing more severe delusions. It has been found to have two factors (Woodward et al., 2014), namely Distress (distress amount, distress intensity) and Frequency (preoccupation amount, preoccupation duration, conviction, disruption). Total scores on these factors can range from 0-8 and 0-16 respectively, with higher scores representing more severe delusions. Both total PSYRATS-D and factor scores will be employed.

    Measured: End of intervention (~4 months)

  4. Hospital Anxiety and Depression scale

    The Hospital Anxiety and Depression scale (HADS; Zigmund \& Snaith, 1983) is a 16-item self-report measure of both anxiety and depression. Eight items assess depression and eight items assess anxiety. Depression scores can range from 0-24 with higher scores representing higher levels of depression. Anxiety scores can range from 0-24 with higher scores representing higher levels of anxiety.

    Measured: End of intervention (~4 months)

  5. Quality of Life Enjoyment and Satisfaction Questionnaire

    Quality of life will be assessed by the short-form of the self-report Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ; Endicott et al., 1993). Total scores on 16-item measure can range from 14 to 70, with higher scores representing greater quality of life.

    Measured: End of intervention (~4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2019
  2. Study start1 Mar 2019
  3. Primary completion25 Mar 2022
  4. Study completion25 Mar 2022

Why it stopped: A national Covid-19 lockdown prevented completion of the trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03852706
Sponsor's protocol ID
206789
Other IDs
25911
Acronym
HALFEED
Status last verified
Mar 2022
First submitted
25 Jan 2019
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing LORETA and Treatment as usual in people with Schizophrenia, run by University of Dublin, Trinity College at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: A national Covid-19 lockdown prevented completion of the trial). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03852706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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HALFEED Clinical Trial NCT03852706 | AzTrials