The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

Auditory Hallucination Clinical Trial

Official title:

The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850923
• Other study ID #: AH-IA-2021
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Shanghai Mental Health Center
• Contact: Jing Shi, Bachelor
• Phone: 86-13774390145
• Email: 1156769381[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• History of alcohol abuse;
• Intellectual impairment (IQ<70);
• Patients with hearing impairment.

Related Conditions & MeSH terms

• Auditory Hallucination
• Hallucinations
• Schizophrenia

Intervention

Other:
• speech competition training
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 music
the soothing music

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jing SHI

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
Primary	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.	Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
Secondary	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.	Change of PANSS score from baseline at 2 weeks and 4 weeks respectively