Comparing the Effectiveness of Social Cognition and Interaction Training (SCIT) Based Group Therapy on Social Cognition and Functioning in Schizophrenic and Bipolar Disorder Patients
Investigating the effectiveness of Social Cognition and Interaction Training (SCIT) group therapy on social cognition and function of patients with schizophrenia and bipolar disorder
Design
Controlled Clinical trial, Random number table will be used for randomization
Settings and conduct
Among the inpatients with schizophrenia or bipolar disorder in the Ostad Moharary Neuropsychiatric Hospital, after explaining the considerations, 30 patients will be selected from each disorder using convenience sampling method. Subjects will be divided into control and intervention groups using randomization. Both will get treatment as usual (TAU). The intervention group will have 18 sessions of SCIT. Both groups will be tested in pre-test, post-test and follow-up.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
inpatients with a diagnosis of schizophrenia and bipolar disorder, over 18 yo, Ability to understand experimental assignments, ability to see and hear normally
Exclusion Criteria:
Presence of current or past developmental disorders, severe head trauma, a history of substance abuse in the past 6 months
Intervention groups
Intervention group beside treatment as usual (TAU) will have 18 sessions of SCIT group therapy four times a week which is designed to help normalize social cognition by remediating deficits and decreasing biases; This group therapy consists of 3 phase (Introduction and Emotions, Figuring Out Situations & Integration). In this therapy Various aids such as paper, SCIT PowerPoint slideshows and video vignettes and varied tasks are used. Control group will only get TAU and participate in evaluation in 3 discrete time periods (pre-test, post-test & follow-up).
Main outcome variables
Social cognition score, social function score, clinical symptoms score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052149N1
Registration date:2023-03-09, 1401/12/18
Registration timing:retrospective
Last update:2023-03-09, 1401/12/18
Update count:0
Registration date
2023-03-09, 1401/12/18
Registrant information
Name
Shima Dehghanzadeh
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 71 3842 9289
Email address
sh.dehghanzadeh183@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-12-18, 1400/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Social Cognition and Interaction Training (SCIT) Based Group Therapy on Social Cognition and Functioning in Schizophrenic and Bipolar Disorder Patients
Public title
Effectiveness of Social Cognition and Interaction Training (SCIT) Based Group Therapy in Schizophrenic and Bipolar Disorder Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
known-case of Schizophrenia Disorder
known-case of Bipolar Disorder
Be at least 18 years old
Ability to understand experimental assignments
Ability to see and hear normally
Exclusion criteria:
Presence of current or past developmental disorders
severe head trauma
a history of substance abuse in the past 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For each intervention group (each bipolar group and Schizophrenia group) 30 subjects will be chosen from available candidates using convenience sampling method. Subjects will be split randomly between two groups, control and intervention groups, each group containing 15 persons. For randomizing the splitting process; initially, an integer code between 01 and 30 will be assigned to each person, then we move and stop our finger randomly and blindfolded on a RAND Corporation random number table, we move on that chosen row to find the corresponding random number and consider the last two digits of the random number. A successful random number is generated if the number is between 01 and 30. The process will continue till 15 random integers in the desired interval is made. 15 selected codes are in the intervention group and the rest are in the control group.
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 Shiraz University of Medical Sciences
Street address
7th Floor, Administration Building of Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-07-28, 1400/05/06
Ethics committee reference number
IR.SUMS.REC.1400.389
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
2
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
social cognition
Timepoint
Before intervention, after intervention & 3 months after in follow-up
Method of measurement
The Hinting Task, and The Penn Emotion Recognition Task (ER-40)
2
Description
social function
Timepoint
Before intervention, after intervention & 3 months after in follow-up
Method of measurement
short form of Social Functioning Scale (SFS), and Nurses’ Observation Scale for Inpatient Evaluation (NOSIE)
3
Description
clinical symptoms
Timepoint
Before & after intervention
Method of measurement
The Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: are consisted of 15 patients who will have group therapy for 18 sessions of 45 to 60 minutes long. Group-therapy sessions will be held 4 times a week. Participants will continue their treatment as usual (TAU).This group therapy consists of 3 phase (Introduction and Emotions, Figuring Out Situations & Integration). Each session has a main topic and target which will be trained by discussing more elaborate subtopics and by practicing various pieces of training. In this therapy Various aids such as paper, PowerPoint slideshows and SCIT video vignettes and varied tasks are used.In the first part, the basic emotions, the relationship between emotions and social situations, and the recognition of emotions according to facial expressions are discussed. The goal of the second part of treatment is to learn and use social cognitive methods to avoid the pitfalls of jumping to conclusions related to social situations. These strategies include generating multiple attributions for negative events, distinguishing social facts from social guesses, tolerating ambiguity in social situations, etc. In the third part, the integration of the skills learned up to this stage and the application of these skills in the lives of patients are discussed. At this stage, patients are encouraged to bring in problematic situations from their daily lives; the group then analyzes the situations and finds behavioral strategies to take steps to reduce interpersonal distress based on the skills they have learned during this treatment.
Category
Treatment - Other
2
Description
Control group: consisted of 15 subjects that will not receive any extra treatment and continue their treatment as usual. They will join pre-test, post-test and follow-up before, after and 3 months later than the intervention respectively.
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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data (without participant personal information) as questionnaire’s raw scores, basic consent form, and general protocols is available for fellow researchers via email application, 6 months after publication of first paper.
When the data will become available and for how long
Accessible 6 months after publication of paper.
To whom data/document is available
For whom the data is useful and usable.
Under which criteria data/document could be used
using in the fields of psychology, psychiatry, and severe mental illness treatment
From where data/document is obtainable
Sending email to the researchers
What processes are involved for a request to access data/document
Requests for information will be reviewed by researchers and information will be sent if relevant to mental health research.