The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

July 4, 2023 updated by: Jing SHI

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Control group
The patient will listen to the soothing music twice a day, each lasting 15 minutes.
Other: the soothing music
the soothing music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory Hallucinations Rating Scale (AHRS)
Time Frame: Change of AHRS score from baseline at 2 weeks and 4 weeks respectively
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)
Time Frame: Change of BAVQ-R score from baseline at 2 weeks and 4 weeks respectively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative and Negative Syndrome Scale (PANSS)
Time Frame: Change of PANSS score from baseline at 2 weeks and 4 weeks respectively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing SHI

Investigators

  • Principal Investigator: Qian Guo, M.D., Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH-IA-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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