Efficacy of Audio Visual Assisted Therapy Aid for Refractory hallucinations (AVATAR) in reducing auditory hallucinations in patients with schizophrenia.
Overall Objective: To determine the effectiveness of Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy) software in reducing auditory hallucinations in patients with schizophrenia.
Design
A clinical trial with a control group, parallel groups, without blinding, will be randomized and performed on 40 patients with schizophrenia. A simple randomization table will be used.
Settings and conduct
This study will be performed at the Razi Educational and Medical Center of Tehran. Patients will be treated with AVATAR or treatment as usual. Pre-test. post-test and follow-up evaluation will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Experiencing annoying auditory hallucinations
2. Age: 18-50
3. Minimum intermediate education
4. Adequate command of the Persian language
5. The patient is able to identify a major sound and hallucination (to reduce).
Exclusion Criteria:
1. Refuse to take any medication
2. Initial dependence on drugs
3. serious thoughts of harming oneself or another
Intervention groups
Patients with schizophrenia will be randomly assigned to an experimental or control group. In the experimental group, AVATAR treatment will be performed and in the control group, treatment, as usual, will be performed.
Main outcome variables
Duration and severity of auditory hallucinations, Depression,Quality of life.
General information
Reason for update
Acronym
AVATAR
IRCT registration information
IRCT registration number:IRCT20220226054121N1
Registration date:2022-05-28, 1401/03/07
Registration timing:prospective
Last update:2022-05-28, 1401/03/07
Update count:0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Vida Yousefi Asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 904 538 2544
Email address
vd.yousefi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Audio Visual Assisted Therapy Aid for Refractory hallucinations (AVATAR) in reducing auditory hallucinations in patients with schizophrenia.
Public title
AVATAR therapy in refractory auditory hallucinations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Experience annoying auditory hallucinations
Age range 18 - 50 years
Minimum Intermediate Education
Sufficient command of Persian language
The patient is able to identify a sound and the main hallucination (to reduce).
Exclusion criteria:
Refuse to take any medication
Primary drug dependence
There are serious thoughts of harming oneself or another
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization using a table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of social welfare and Rehabilitation Sciences.
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.USWR.REC.1400.292
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Duration and severity of resistant auditory hallucinations
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
The Psychotic Symptom Rating Scale (PSYRAT)
Secondary outcomes
1
Description
beliefs about voices
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
The revised beliefs about voices questionnaire (BAVQ–R).
Intervention groups
1
Description
Intervention group: In the experimental group, patients undergo Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy) . This treatment consists of 6, 45-minute treatment sessions in which the patient and the therapist communicate through the designed AVATAR software and a conversation is formed between them that helps the patient gradually feel in control and the duration and intensity Reduce illusions.
Category
Treatment - Other
2
Description
Control group: In the control group, patients undergoing treatment as usual under the supervision of a psychiatrist. The dose and duration of use will be determined by a psychiatrist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Dr. Ali Nazeri Astaneh
Street address
Tehran Province, Tehran, Jaddeh-ye-Amin Abad
City
Tehran
Province
Tehran
Postal code
1867612016
Phone
+98 21 3340 1220
Email
razi.pr@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. HamidReza Khoram khorshid
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Farhad Taremian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0045
Email
taremian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Farhad Taremian
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kodakyar Ave, daneshjo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
71732000
Email
taremian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Vida Yousefi Asl
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 914 691 7165
Email
vida.yousefi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available