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Evaluation of the effect of community Re-entry Program(CRP) on mental state and social function in chronic psychiatric patients

Protocol summary

Summary
(1)Objective: The effect of Community Re-entry Program on social function of patients with chronic mental disorders.(2)Design: The study was a randomized clinical trial which was conducted among patients (men and women) with chronic mental illness, attended daily rehabilitation centers in Hamadan, with a sample size of 40 patients (20 female and 20 male). (3) Setting and conduct:This randomized controlled clinical trial was conducted after making the necessary arrangements by outpatient rehabilitation centers of Hamadan, Iran. Based on the inclusion and exclusion criteria of the study, 40 patients (20 males and 20 females) were selected through purposive sampling and were randomly assigned to an intervention and a control group using block randomization method. Before randomization, occupational therapist asked members of both study groups to complete communication and interaction skills questionnaire and positive and negative syndrome scale. After randomization, patients in the intervention group took part in educational sessions in 2 groups of 6 people and 1 group of 8 people. The educational sessions were held in the rehabilitation centers twice a week (each lasting for 60-90 minutes) for two months. Post-test was performed using Assessment Of communication And Interaction Skill (ACIS) questionnaire at the end of the study (two months) and also two weeks later to do follow-up. Patients in the control group only received the rehabilitation centers’ routine treatments (occupational therapy, psychotherapy, and pharmacotherapy).(4)The inclusion criteria:1- Having schizophrenia and mood disorders based on DSM-IV diagnostic criteria approved by a psychiatrist, 2-Aged between 20-65 years, 3-Affected by the disease for at least two years, not having history of recurrence, hospitalization, and change in medications in the past two months, 4-having willingness to participate in the study. The exclusion criteria:1-Having history of any acute medical conditions and neurological damages, 2-Suffering from mental retardation. (5) Intervention: Running 16 sessions of Community Re-entry Program(CRP) for patients in this group. The control group did not receive aformentioned program. (6)Main outcome measures: Social function and mental state

General information

Acronym
CRP
IRCT registration information
IRCT registration number: IRCT2016051424468N2
Registration date: 2016-05-30, 1395/03/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Farkhondeh Jamshidi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
f.jamshidi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Hamadan University of Medical Sciences
Expected recruitment start date
2015-04-07, 1394/01/18
Expected recruitment end date
2015-06-02, 1394/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of community Re-entry Program(CRP) on mental state and social function in chronic psychiatric patients
Public title
Effect of Community Re-entry Program(CRP) on Chronic Mental Illnesses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1- diagnostic Confirmation of chronic psychiatric disorders by a psychiatrist according to the DSM-IV diagnostic criteria; 2- Aged between 20 and 65 years; 3- At least 2 years passed from the onset of the illness and being in the chronic phase of the disease without a history of symptoms' recurrence , psychotic attack, hospitalization and medical regimen change within last 2 weeks; 4-having the desire to participate in the research and cooperate in all phases of evaluations. Exclusion criteria: 1- Extrapyramidal system disorders (tremor, balance disorders, acute and delayed dystonia, Parkinsonism syndrome) so that social activity is prevented; 2- deafness, blindness and sensation disability that can not be compensated with assistant devices; 3- history of any neurological illness and injuries (such as head trauma, coma, Alzheimer's disease, any type of dementia, epilepsy or stroke); 4-Mental retardation; 5- Electroconvulsive therapy (ECT) in the last 6 months; 6- lack of desire to continue the trial
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study was a randomized clinical trial with available samples. Samples were randomized into two groups using block randomization method

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh BLV, Pajohesh Intersection, Hamadan, University of Medical Sciences
City
Hamadan
Postal code
-
Approval date
2014-12-24, 1393/10/03
Ethics committee reference number
16/35/4793/پ

Health conditions studied

1

Description of health condition studied
Chronic Mental Disorder
ICD-10 code
F30, F31,
ICD-10 code description
Bipolar affective disorder,Manic episode, Depressive episode, Schizophrenia

Primary outcomes

1

Description
social function
Timepoint
Before and one week after intervention
Method of measurement
Assessment Of communication And Interaction Skill (ACIS) questionnaire

2

Description
mental state
Timepoint
Before and one week after intervention
Method of measurement
Positive And Negative Syndrome Scale(PANSS)

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention Group: Community Re-entry Program,16 sessions, two 60-minute to 90-minute sessions per week
Category
Rehabilitation

2

Description
Control group: Did not received Community Re-entry program
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Alvand and Tabesh rehabilitation Centers
Full name of responsible person
Moradi Ghane
Street address
No. 19, Najarkhaneh Alleys, Sizdah khaneh, Hamedan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Opposite the People's Park, Shahid Fahmideh BLV, Pajohesh Intersection, Vice Chancellor for Research, University of Medical Sciences, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Farkhondeh Jamshidi
Position
Instructor of rehabilitation
Other areas of specialty/work
Street address
Opposite the People's Park, Shahid Fahmideh BLV, Pajohesh Intersection, Vice Chancellor for Research, University of Medical Sciences, Hamadan
City
Hamadan
Postal code
-
Phone
+98 81 3838 1571
Fax
-
Email
farkhondeh.jamshidi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farkhondeh Jamshidi
Position
Master of Science
Other areas of specialty/work
Street address
Opposite the People's Park, Shahid Fahmideh BLV, Pajohesh Intersection, Vice Chancellor for Research, University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
farkhondeh.jamshidi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Frkhondeh Jamshidi
Position
Instructor of rehabilitation
Other areas of specialty/work
Street address
Opposite the People's Park, Shahid Fahmideh BLV, Pajohesh Intersection, Vice Chancellor for Research, University of Medical Sciences, Hamadan
City
Hamadan
Postal code
-
Phone
+98 81 3838 1571
Fax
-
Email
farkhondeh.jamshidi@yahoo.com
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
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