The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

NCT ID: NCT05850923

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Auditory Hallucination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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a speech competition experimental group

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.

Group Type EXPERIMENTAL

speech competition training

Intervention Type OTHER

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.

Control group

The patient will listen to the soothing music twice a day, each lasting 15 minutes.

Group Type ACTIVE_COMPARATOR

the soothing music

Intervention Type OTHER

the soothing music

Interventions

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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.

Intervention Type OTHER

the soothing music

the soothing music

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jing SHI

OTHER

Sponsor Role lead

Responsible Party

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Jing SHI

Nurse practitioner

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qian Guo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Shi, Bachelor

Role: CONTACT

86-13774390145

Qian Guo, M.D.

Role: CONTACT

86-13761005210

Facility Contacts

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Jing Shi, Bachelor

Role: primary

86-13774390145

Other Identifiers

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AH-IA-2021

Identifier Type: -

Identifier Source: org_study_id

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