Protocol summary

Summary
The aim of this study is to evaluate the efficacy of social skills training on symptoms and quality of life in patients with schizophrenia and schizoaffective disorder. Patients (males and females aged 18-65) with schizophrenia and schizoaffective disorder based on the DSM-IV-TR diagnostic criteria in the interview, whom will have the need to receive rehabilitation services, will be selected. These patients, will be in remission phase and will be treated, by conventional medications. Inclusion criterion: 1) men or women with schizophrenia or schizoaffective disorder (according to DSM IV-TR classification and interview) 2)18-65 years old 3) At least fifth grade education 4) Being in remission ( according to clinical judgment by psychiatrist, resident or faculty member and PANSS score) 5) being on medication 6) informed consent to participate in the study Exclusion criterion: 1) Age fewer than 18 or over 65 2) Presence of other psychiatric disorders (mood disorders, substance related disorder exception nicotine dependence in last year, anxiety disorders and obsessive compulsive disorder) 3) presence of any brain damage or neurological disorders or serious medical conditions 4) intellectual disability The sample size is 18. The benefits of attending educational sessions will be explained to patients and families and the written informed consent will be obtained. After that, preliminary assessment and history taking will be done by a trained psychologist and assessment by HDRS ( Hamilton Depression Rating scale), PANSS (Positive and Negative Symptom Scale), GAF (global assessment of function) and WHO-QOL( World Health Organization- quality of life) will be done too. After the initial assessment, patients will participate in social skills training sessions twice a week for about an hour to an hour and a half. This training is based on Wallace method. The content of sessions are: listening, make a request, the skills for expression of pleasant and unpleasant emotions, criticizing, initiation of a conversation , maintaining the conversation , ending of conversation, making conversation with unfamiliar person, the principles of conversations, find common ground and problem solving. These training will be taught, by a trained occupational therapist and a trained psychiatrist assistant, who were participated in social skills training workshops. Repetition, positive reinforcement and role playing, are the most common techniques which be used in this method. At the end of the 12 training sessions (after 6 weeks) and 3 months after the last session, re-evaluation with PANSS, GAF, HDRS, WHO-QOL and CSQ will be done again, by a trained psychologist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016043027691N1
Registration date: 2016-10-30, 1395/08/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Zahra Mirsepassi
Name of organization / entity
Roozbeh Hospital- Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 1811
Email address
z-mirsepassi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
preliminary evaluation of social skills training on symptom control and quality of life in patients with schizophrenia or schizo-affective disorder
Public title
Effect of social skills training in patients with schizophrenia or schizo-affective disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: 1) men or women with schizophrenia or schizoaffective disorder (according to DSM IV-TR classification and interview) 2) 18-65 years old 3) At least fifth grade education 4) Being in remission ( according to clinical judgment by psychiatrist, resident or academic member) 5) Being on medication Exclusion criterias: 1) Age fewer than 18 or over 65 2) Presence of other psychiatric disorders (mood disorders, substance related disorder exception nicotine dependence in last year, anxiety disorders and obsessive compulsive disorder) 3) Presence of any brain damage or neurological disorders or serious medical conditions 4) intellectual disability
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
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 Tehran University of Medical Sciences
Street address
Medical School, Poorsina Street, 16 Azar Avenue,Tehran
City
Tehran
Postal code
1417613151
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.TUMS.VCR.REC.1395-395

Health conditions studied

1

Description of health condition studied
schizophrenia or schizoaffective disorder
ICD-10 code
F20, F25
ICD-10 code description
Schizophrenia, Schizoaffective disorders

Primary outcomes

1

Description
positive symptoms
Timepoint
at the first and after termination of social skills training sessions( after 6 weeks ) and 12 weeks after the last session
Method of measurement
positive and negative symptom scale

2

Description
negative symptoms
Timepoint
at the first and after termination of social skills training sessions( after 6 weeks) and 12 weeks after the last session
Method of measurement
positive and negative symptom scale

3

Description
quality of life
Timepoint
at the first and after termination of social skills training sessions( after 6 weeks) and 12 weeks after the last session
Method of measurement
World Health Organisation-Quality Of Life

Secondary outcomes

1

Description
client satisfaction
Timepoint
after 6 weeks
Method of measurement
Client Satisfaction Questionnaire

2

Description
global patients performance
Timepoint
at the first and after termination of social skills training sessions( after 6 weeks) and 12 weeks after the last session
Method of measurement
Global Assessment of Function

3

Description
depression
Timepoint
at the first and after termination of social skills training sessions (after 6 weeks) and 12 weeks after the last session
Method of measurement
Hamilton Depression Rating Scale

Intervention groups

1

Description
patients will participate in social skills training sessions based on Wallace method. The frequency of sessions are twice a week and each session lasts for about an hour to an hour and a half. The content of sessions are: listening, make a request, the skills for expression of pleasant and unpleasant emotions, criticizing, initiation of a conversation , maintaining the conversation , ending of conversation, making conversation with unfamiliar person, the principles of conversations, find common ground and problem solving. These training will be taught, by a trained occupational therapist and a trained psychiatrist assistant, who were participated in social skills training workshops. Repetition, positive reinforcement and role playing, are the most common techniques.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Day center, Roozbeh Hospital
Full name of responsible person
Zahra Mirsepassi
Street address
South Kargar Ave, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Street address
Enghelab Avenue, Ghods street, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Roozbeh Hospital, Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Position
Psychiatrist, assistant professsor
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Avenue, Tehran, Iran
City
Tehran
Postal code
1333715914
Phone
+98 21 5541 4084
Fax
Email
zahesbanoo@yahoo.comz-mirsepassi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Roozbeh Hospital, Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Position
Psychiatrist, assistant professor
Other areas of specialty/work
Street address
Day Center, Roozbeh Hospital, South Kargar Avenue, Tehran, Iran
City
Tehran
Postal code
1333715914
Phone
+98 21 5541 4084
Fax
Email
zahesbanoo@yahoo.comz-mirsepassi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Roozbeh Hospital, Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepassi
Position
psychiatrist, assistant professor
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Avenue, Tehran, Iran
City
Tehran
Postal code
1333715914
Phone
+98 21 5541 4084
Fax
Email
zahesbanoo@yahoo.com, z-mirsepassi@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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