Auditory HallucinationNCT05850923
The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia
A study testing speech competition training and the soothing music in people with Auditory Hallucination, run by Jing SHI at 1 site in China.
Trial summary
One hundred schizophrenia patients with auditory hallucinations will be recruited and randomized into group A and group B. Participants of group A will firstly receive a speech competition training for 2 weeks, and those in group B will firstly receive music intervention as placebo treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Auditory Hallucination
- What is being tested?
- speech competition training and the soothing music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to 30 Jun 2024
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfilling the diagnostic criteria for schizophrenia as in the International Classification of Diseases (ICD) - 10;
- Aged 18-55 years old;
- Education level over 6 years;
- The score of P3 item in PANSS ≥ 3 points;
- Taking antipsychotics at a therapeutic dose for at least 1 month, and the symptoms of auditory hallucinations have not been significantly improved, and the score of Auditory Hallucinations Rating Scale (AHRS) is still greater than 18 points;
- Capable of understanding and singing a written informed consent form, and be able to cooperate in completing intervention training and assessments.
Who cannot join
- Diagnosing other Axis I mental disorders;
- A history of severe neurological disease, brain trauma, major physical disease or history of drug dependence;
- Auditory hallucinations caused by organic brain diseases;
- Patients who cannot cooperate with the completion of training;
- Patients with serious suicidal or self injurious behavior;
- Pregnant and lactating women;
Show all 9Show fewer
- History of alcohol abuse;
- Intellectual impairment (IQ<70);
- Patients with hearing impairment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
Jing Shi, Bachelor, 86-13774390145, 1156769381@qq.com
About this study
One hundred schizophrenia patients with auditory hallucinations will be recruited and randomized into group A and group B. Participants of group A will firstly receive a speech competition training for 2 weeks, and those in group B will firstly receive music intervention as placebo treatment. Specifically, speech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction. The reaction time, accuracy rate and the number of auditory hallucinations during the task will be recorded. On the other hand, the placebo treatment includes soothing music twice a day for a fixed period of time while patients receiving drug treatment. After 2 weeks, the interventions for group A and group B will be switch.
Clinical symptoms will be evaluated using the auditory hallucinations rating scale, positive and negative syndrome scale, belief about voices questionnaire-revised at baseline, 2-week follow up and 4-week follow up. All the data will be analyzed with the Statistical Product and Service Solutions(SPSS) software.
- Conditions
- Auditory Hallucination
- Being tested
- speech competition training, the soothing music
- Keywords
- Schizophrenia, Intervention
- Medical subject headings
- Hallucinations, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech competition trainingOther
Speech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction.
the soothing musicOther
the soothing music
| Study group | Role | What they receive |
|---|---|---|
| a speech competition experimental group | Experimental | The speech competition training was arranged twice a day, each lasting 15 minutes. The training included word search in sequence, word search out of order and word sorting. Patients need to follow the instructions in time for training. The reaction time, accuracy rate and the number of auditory hallucinations during the task were recorded. Receives: Other: speech competition training |
| Control group | Active comparator | The patient will listen to the soothing music twice a day, each lasting 15 minutes. Receives: Other: the soothing music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Hallucinations Rating Scale (AHRS)
The Hoffman Hallucination Rating Scale (AHRS) is a clinical tool used to assess the severity of auditory hallucinations in patients. In current study, the scale is used to evaluate the severity of auditory hallucinations in patients with schizophrenia, mainly from seven aspects: frequency, authenticity, loudness, number of sounds, duration, attention significance, and pain level.
Measured: Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
Belief About Voices Questionnaire-Revised (BAVQ-R)
This scale is a self-assessment scale developed by Chadwick et al., used to measure the beliefs, emotions, and behaviors of patients with auditory hallucinations, with a total of 35 items. Straus et al. reconducted factor analysis on its basis and extracted four factors, namely victim belief (authority belief+malicious belief), goodwill belief, participation in auditory hallucinations, and resistance to auditory hallucinations. The scale items are scored using the Likert 4-level scoring method, with a score of 0-3 and independent scores for each dimension.
Measured: Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
Secondary outcomes (1)
Negative and Negative Syndrome Scale (PANSS)
The Negative and Positive Symptoms Scale is a widely used scale for assessing patients' clinical symptoms. The PANSS scale has a total of 30 items, including three subscales of positive symptoms, negative symptoms and general psychopathological symptoms. Each item is scored 1-7 in increasing order of severity. The sum of the items contained in the factor is the factor score, and the scores of all items are added to obtain the total score.
Measured: Change of PANSS score from baseline at 2 weeks and 4 weeks respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start15 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory HallucinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- At first, all the participants will be randomized into a speech competition experimental group and a placebo control group, after 2 weeks the two interventions for two arms will be switch.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing SHI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing SHI, Shanghai Mental Health Center
- Investigators
- Qian Guo, M.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850923
- Sponsor's protocol ID
- AH-IA-2021
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia
- ClinicalTrials.gov ID
- NCT05850923
- Acronym / sponsor ID
- AH-IA-2021
- Conditions
- Auditory Hallucination
- Keywords
- Schizophrenia, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jing SHIUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One hundred schizophrenia patients with auditory hallucinations will be recruited and randomized into group A and group B. Participants of group A will firstly receive a speech competition training for 2 weeks, and those in group B will firstly receive music intervention as placebo treatment. Specifically, speech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction. The reaction time, accuracy rate and the number of auditory hallucinations during the task will be recorded. On the other hand, the placebo treatment includes soothing music twice a day for a fixed period of time while patients receiving drug treatment. After 2 weeks, the interventions for group A and group B will be switch.
Clinical symptoms will be evaluated using the auditory hallucinations rating scale, positive and negative syndrome scale, belief about voices questionnaire-revised at baseline, 2-week follow up and 4-week follow up. All the data will be analyzed with the Statistical Product and Service Solutions(SPSS) software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- At first, all the participants will be randomized into a speech competition experimental group and a placebo control group, after 2 weeks the two interventions for two arms will be switch.
| Arm | Type | Receives |
|---|---|---|
| a speech competition experimental group | Experimental | Other: speech competition trainingThe speech competition training was arranged twice a day, each lasting 15 minutes. The training included word search in sequence, word search out of order and word sorting. Patients need to follow the instructions in time for training. The reaction time, accuracy rate and the number of auditory hallucinations during the task were recorded. |
| Control group | Active comparator | Other: the soothing musicThe patient will listen to the soothing music twice a day, each lasting 15 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Fulfilling the diagnostic criteria for schizophrenia as in the International Classification of Diseases (ICD) - 10;
- Aged 18-55 years old;
- Education level over 6 years;
- The score of P3 item in PANSS ≥ 3 points;
- Taking antipsychotics at a therapeutic dose for at least 1 month, and the symptoms of auditory hallucinations have not been significantly improved, and the score of Auditory Hallucinations Rating Scale (AHRS) is still greater than 18 points;
Key exclusion criteria (9 listed)
- Diagnosing other Axis I mental disorders;
- A history of severe neurological disease, brain trauma, major physical disease or history of drug dependence;
- Auditory hallucinations caused by organic brain diseases;
- Patients who cannot cooperate with the completion of training;
- Patients with serious suicidal or self injurious behavior;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speech competition trainingSpeech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction. | Other | a speech competition experimental group |
| the soothing musicthe soothing music | Other | Control group |
Primary outcome
Auditory Hallucinations Rating Scale (AHRS)
Time frame: Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
The Hoffman Hallucination Rating Scale (AHRS) is a clinical tool used to assess the severity of auditory hallucinations in patients. In current study, the scale is used to evaluate the severity of auditory hallucinations in patients with schizophrenia, mainly from seven aspects: frequency, authenticity, loudness, number of sounds, duration, attention significance, and pain level.
Belief About Voices Questionnaire-Revised (BAVQ-R)
Time frame: Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
This scale is a self-assessment scale developed by Chadwick et al., used to measure the beliefs, emotions, and behaviors of patients with auditory hallucinations, with a total of 35 items. Straus et al. reconducted factor analysis on its basis and extracted four factors, namely victim belief (authority belief+malicious belief), goodwill belief, participation in auditory hallucinations, and resistance to auditory hallucinations. The scale items are scored using the Likert 4-level scoring method, with a score of 0-3 and independent scores for each dimension.
1 secondary outcome
Negative and Negative Syndrome Scale (PANSS)
Time frame: Change of PANSS score from baseline at 2 weeks and 4 weeks respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Guo, M.D. principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech competition training and the soothing music in people with Auditory Hallucination, run by Jing SHI at 1 site in China.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Shi, Bachelor (86-13774390145, 1156769381@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Hallucinations Rating Scale (AHRS) (time frame: Change of AHRS score from baseline at 2 weeks and 4 weeks respectively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2023.