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The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

Primary Purpose

Auditory Hallucination

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
speech competition training
the soothing music
Sponsored by
Jing SHI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auditory Hallucination focused on measuring Schizophrenia, Intervention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

a speech competition experimental group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 19, 2023
Last Updated
July 4, 2023
Sponsor
Jing SHI
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1. Study Identification

Unique Protocol Identification Number
NCT05850923
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing SHI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucination
Keywords
Schizophrenia, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
a speech competition experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patient will listen to the soothing music twice a day, each lasting 15 minutes.
Intervention Type
Other
Intervention Name(s)
speech competition training
Intervention Description
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
Intervention Name(s)
the soothing music
Intervention Description
the soothing music
Primary Outcome Measure Information:
Title
Auditory Hallucinations Rating Scale (AHRS)
Description
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.
Time Frame
Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
Title
Belief About Voices Questionnaire-Revised (BAVQ-R)
Description
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.
Time Frame
Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
Secondary Outcome Measure Information:
Title
Negative and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
Change of PANSS score from baseline at 2 weeks and 4 weeks respectively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Shi, Bachelor
Phone
86-13774390145
Email
1156769381@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Guo, M.D.
Phone
86-13761005210
Email
guoqian1205@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qian Guo, M.D.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Shi, Bachelor
Phone
86-13774390145
Email
1156769381@qq.com

12. IPD Sharing Statement

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The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

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