Clinical trial NCT05850923: The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia
Official title: The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Auditory Hallucination
Keywords: Schizophrenia
Intervention
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Auditory Hallucinations Rating Scale (AHRS)
timeFrame: Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
measure: Belief About Voices Questionnaire-Revised (BAVQ-R)
timeFrame: Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
Secondary outcomes:
measure: Negative and Negative Syndrome Scale (PANSS)
timeFrame: Change of PANSS score from baseline at 2 weeks and 4 weeks respectively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Qian Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: