The effectiveness of cognitive-behavioral therapy (CBT) on positive and negative psychotic symptoms and emotional regulation in patients with schizophrenia: A single-case pilot design for five patients with schizophrenia spectrum disorders
Determining the effectiveness of cognitive-behavioral therapy on positive and negative psychotic symptoms and emotional regulation in patients with schizophrenia spectrum disorders
Design
Clinical trial on five patients with schizophrenia spectrum disorders, With a single group, without blindness,
Settings and conduct
The field of research is to examine the cognitive-behavioral therapy on positive and negative psychotic symptoms and emotional regulation of patients with schizophrenia spectrum disorders. A clinical trial was performed at Razi Psychiatric Hospital in Tehran. Patient assessment was performed in all sessions. The study was before after type. First, baseline data were collected, then intervention phase data, and finally follow-up phase data were collected.
Participants/Inclusion and exclusion criteria
1: Diagnosis of schizophrenia based on DSM5 criteria; 2: Relative control of acute symptoms of patients; 3: Average age 18 to 45 years; 4: Voluntary attendance with informed written consent Research; 5: Research Having a minimum education with a diploma certificate; 6: Receiving a higher score on PANSS and DERS scales Compared to other patients; 7: Patients who have been in the ward for at least one week
Intervention groups
Five patients with schizophrenia spectrum disorders participated in treatment sessions on a single-subject basis. Each patient is considered as his/her own control. The patient's symptoms or adaptive functioning were assessed over time and during the sessions. In the intervention sessions, Patients learned how to cope with hallucinations and delusions, as well as how to express emotions.
Main outcome variables
Emotional regulation; positive and negative psychotic symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210412050937N2
Registration date:2021-12-14, 1400/09/23
Registration timing:retrospective
Last update:2021-12-14, 1400/09/23
Update count:0
Registration date
2021-12-14, 1400/09/23
Registrant information
Name
Hamid Khakbaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5591 5322
Email address
ham.khakbaz@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-18, 1399/10/29
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
2021-01-19, 1399/10/30
Actual recruitment end date
2021-03-18, 1399/12/28
Trial completion date
2021-03-18, 1399/12/28
Scientific title
The effectiveness of cognitive-behavioral therapy (CBT) on positive and negative psychotic symptoms and emotional regulation in patients with schizophrenia: A single-case pilot design for five patients with schizophrenia spectrum disorders
Public title
The effectiveness of cognitive-behavioral therapy (CBT) on positive and negative psychotic symptoms and emotional regulation in patients with schizophrenia spectrum disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia spectrum disorders based on DSM5 criteria
Relative control of acute symptoms of patients
Average age 18 to 45 years
Voluntary attendance with informed written consent Research
Having a minimum education with a diploma certificate
Receiving a higher score on PANSS and DERS scales Compared to other patients
Patients who have been in the ward for at least one week
Exclusion criteria:
No criminal or judicial problems
Alcohol or substance abuse
Neurological disorders such as epilepsy, stroke or severe concussion
High levels of disordered behavior or high risk of suicide or homicide
Diagnosis Mental retardation.
Severe learning disability
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Actual sample size reached:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
3rd floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran
City
Shahr-e-Rey
Province
Tehran
Postal code
1841744558
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.USWR.REC.1399.013
Health conditions studied
1
Description of health condition studied
Schizophrenia spectrum disorders
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive and negative psychotic symptom score in Schizophrenia positive and negative symptom scale
Timepoint
Measures of The Positive and Negative Psychotic Symptoms two weeks before the start of the intervention (three baseline), all intervention sessions (16 Sessions), and 3 months after the end of the intervention (three follow-up lines)
Method of measurement
The Positive and Negative Psychotic Symptoms Scale
2
Description
Emotional regulation score in the Gratz and Roemer Emotional Regulation Difficulties Scale
Timepoint
Measures of emotional regulation two weeks before the start of the intervention (three baseline), all intervention sessions (16 sessions), and 3 months after the end of the intervention (three follow-up lines)
Method of measurement
Gratz and Roemer Emotional Regulation Difficulties Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Five patients with schizophrenia spectrum disorders participated in treatment sessions on a single-subject basis. The Cognitive-behavioral Therapy Manual consists of 16 sessions, each lasting 60 minutes. Two treatment sessions are performed for each patient every week. The duration of all treatment sessions was 60 days. CBT offers assessment of psychotic symptoms, Psycho-Education, working on hallucinations and delusions, self-management programs, stress vulnerability model, relaxation technique and treatment tasks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Educational And Therapeutic Psychiatric Center
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khorram Khorshid
Street address
Koodakyar Deadened, Deneshjoo BLV, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
khakbaz.hamid@gmail.com
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
Hamid Khakbaz
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran
City
Shahr_e_Rey
Province
Tehran
Postal code
1841744558
Phone
+98 21 5591 5322
Email
khakbaz.hamid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Khakbaz
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran
City
Shahr_e_Rey
Province
Tehran
Postal code
1841744558
Phone
+98 21 5591 5322
Email
khakbaz.hamid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Khakbaz
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd Floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran
City
Shahr-e-Rey
Province
Tehran
Postal code
1841744558
Phone
+98 21 5591 5322
Email
Khakbaz.hamid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After deleting the confidential information, I will share the data file of the patients of this research with other researchers; including age, sex, occupation, education and marital status.
When the data will become available and for how long
Start of access period 3 months after the end of treatment and follow-up
To whom data/document is available
The data is only available to research colleagues and other researchers and practitioners
Under which criteria data/document could be used
The data can be used for publication in scientific research journals. Researchers are not allowed to do any analysis and they can only view and receive the data and analyze it. Researchers are also required to make a written commitment not to publish the data file.
From where data/document is obtainable
Send me an email: khakbaz.hamid@gmail.com
Also refer to the following address: Hamid Khakbaz, Department of Counseling, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd., Evin, Tehran phone number: 09129484583
What processes are involved for a request to access data/document
After sending me an email and confirming the identity of the applicant, and the final confirmation of the research colleagues, the data will be sent to them. The approximate time will be 2 to 3 months