The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2022
CompletedFirst Submitted
Initial submission to the registry
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 6, 2023
July 1, 2023
1.6 years
April 19, 2023
July 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Negative and Negative Syndrome Scale (PANSS)
Change of PANSS score from baseline at 2 weeks and 4 weeks respectively
Study Arms (2)
a speech competition experimental group
EXPERIMENTALThe 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 COMPARATORThe patient will listen to the soothing music twice a day, each lasting 15 minutes.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jing SHIlead
Study Sites (1)
Shanghai Mental Health Center
Shanghai, 200030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qian Guo, M.D.
Shanghai Mental Health Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Nurse practitioner
Study Record Dates
First Submitted
April 19, 2023
First Posted
May 9, 2023
Study Start
November 15, 2022
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
July 6, 2023
Record last verified: 2023-07