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The effect of rehabilitation interventions with emphesis on token economy on participation of chronic mental illness

Protocol summary

Study aim
The effect of rehabilitation interventions with emphesis on token economy on participation of chronic mental illness residents in OmidFarda rehabilitation center
Design
The sampling method is available and is determined by the Omid Farda Rehabilitation Center in Tehran, based on the sample size formula. According to the entry criteria, among the 63 chronic mental patients living in the center, the sample size is expected to be 20 people.
Settings and conduct
The rehabilitation intervention based on the individual needs of each client is performed on people with chronic mental illness at the Omid Farda Rehabilitation Center in Tehran after a complete evaluation, and if the client performs well, the desired behavior is immediately reinforced using a token, which can be exchanged with desired reward. In case of unpleasant behavior, the token will be withdrawn from the client in order to remove the behavior.
Participants/Inclusion and exclusion criteria
exclusion criteria: participants who Receive a diagnosis from the center's psychiatrist, Willingness to cooperate, At least 6 months after staying in the center, Age 20-60 year, People who have problems in performing daily life activities Exclusion criteria: Having mental retardation , Being in the acute stages of the disease, The presence of cognitive and physical defects
Intervention groups
It is expected that the interventions of the clients include skills training and interventions based on occupation. Each client's individual occupational therapy intervention program is implemented by the researcher with token reinforcement, and similarly, the token is given to the client in exchange for the implementation of the target behavior, explaining to the client that the reason for receiving the token is his/her appropriate performance.
Main outcome variables
motivation _ occupational engagement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230530058345N1
Registration date: 2023-06-03, 1402/03/13
Registration timing: prospective

Last update: 2023-06-03, 1402/03/13
Update count: 0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Fatemeh Ghojoghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
f.ghojoghi98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rehabilitation interventions with emphesis on token economy on participation of chronic mental illness
Public title
The effect of rehabilitation interventions with emphesis on token economy on participation of chronic mental illness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving a diagnosis from the psychiatrist of the center Willingness to cooperate At least 6 months after staying in the center Age 20-60 years old People who have problems in performing daily life activities
Exclusion criteria:
having mental retardation as diagnosed by a doctor Being in the acute stages of the disease The presence of cognitive and physical defects that prevent participation with the doctor's diagnosis
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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 Iran University of Medical Sciences
Street address
Tehran, Quds town, between South Flamak and Zarafshan, Simai Iran Street - Ministry of Health, Treatment and Medical Education Central Headquarters, block A, 13th floor
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.IUMS.REC.1402.026

Health conditions studied

1

Description of health condition studied
chronic mental disorder
ICD-10 code
F20, F31
ICD-10 code description
Schizophrenia, Bipolar affective disorder

Primary outcomes

1

Description
occupational engagement
Timepoint
before and after treatment
Method of measurement
profile of occupational engagement for severe mental illness

2

Description
motivation
Timepoint
before and after treatment
Method of measurement
volitional questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rehabilitation interventions with emphesis on token economy: Token economy is done by allocating fake coins (tokens) in exchange for the performance of desired occupation according to the special goals of each client (for example, personal hygiene) or avoiding inappropriate actions, which can be finally exchanged with clients' favorite boosters.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Farda
Full name of responsible person
Mehrnoush Kaveh
Street address
End of Hemet Gharb highway, Kharazi highway, Shahid Ardestani St., Danesh St., Danesh Yak, Omid Farda Rehabilitation
City
Tehran
Province
Tehran
Postal code
۰۰۰۰
Phone
+98 21 4612 3065
Email
dr.esmaeilmahboubi@omidfarda.org

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical 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
Iran University of Medical Sciences
Full name of responsible person
Elahe Hojati Abed
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
elahe_hojati@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elahe Hojati Abed
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۳۴۸۷ ۱۵۴۵۹۱
Phone
+98 21 2222 7124
Email
elahe_hojati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elahe Hojati Abed
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad, Shah Nazari St., Maddkaran St., Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۳۴۸۷ ۱۵۴۵۹۱
Phone
+98 21 2222 7124
Email
elahe_hojati@yahoo.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
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
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
Clinicians, researchers and centers related to the rehabilitation of clients with psycho-social disabilities
Under which criteria data/document could be used
For use by clinicians or for conducting further research
From where data/document is obtainable
Refer to the e-mail address elahe_hojati@yahoo.com or contact number 021222267124 for Dr. Elahe Hojati Abid at the Faculty of Rehabilitation of Iran University of Medical Sciences.
What processes are involved for a request to access data/document
After seeing the submission of the application and if a month has passed since the publication of the results, the files will be made available.
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