The investigation of Occupational engagement of people with mental illness participating in center based on Club House model
Design
The clinical trial has a control group with randomized double-blind parallel groups. The sample size includes 32 people in two control and intervention groups, and the random number table method is used for randomization
Settings and conduct
Interventions will be held in the psychosocial occupational therapy clinic of the Rehabilitation Faculty of Iran University of Medical Sciences and the day care center of Iran Psychiatric Hospital. The intervention period will be held for 2 months, two 3-hour sessions per week. Clubhouse program activities are done in groups and include cooking, artistic activities such as painting and drawing, etc., health services such as sports, administrative activities, accounting and maintenance of the center and working with computers. and the research team is also in contact with their family members and counseling is done if needed. Evaluations are done using COPM and POES tools by an occupational therapy expert. who is not aware of the grouping of people. The participants are also unaware of the main intervention.
Participants/Inclusion and exclusion criteria
Eligible: Up to 18 years old, Have a psychiatric diagnosis, Having informed consent, In a certain range of psychosocial function (Global Assessment Function)
Ineligible: People who have dementia and substance abuse as their primary diagnosis
Intervention groups
In the intervention group, all interventions based on the Clubhouse model are performed
In the control group, all the interventions that are common in daily occupational therapy centers
Main outcome variables
Rhythm of activity and rest؛ Occupational performance environment and diversity, Social environment; Social interaction; Interpretation; Level of meaningful activities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230820059199N1
Registration date:2023-08-26, 1402/06/04
Registration timing:prospective
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
elahe hojati Abed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
hojatiabed.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of Occupational engagement of people with mental illness participating in center based on Club House model
Public title
Interventions based on the Clubhouse model in mental patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have a psychiatric diagnosis and enter the plan with written consent. People who are in a certain range of psychosocial function (Global Assessment Function) with the general function assessment scale should be included in the groups.People who cannot enter the plan, people who have dementia and substance abuse as their primary diagnosis, or who do not agree to participate in the plan.
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are divided into two groups by a simple randomization method. The randomization tool is a table of random numbers. The participants are divided into two control and intervention groups with a 1:1 allocation. Concealment is done using sealed and waxed opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants invited to the intervention and use of supportive interventions are blinded to study groups. Because both groups receive supportive interventions. Two occupational therapy experts who evaluated the data and outcome were blinded to the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university medical of sciences
Street address
occupational therapy department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2023-01-22, 1401/11/02
Ethics committee reference number
IR.IUMS.REC.1401.844
Health conditions studied
1
Description of health condition studied
People with Chronic Mental Disease, Illness, Disorder, Disability
ICD-10 code
F20-F99
ICD-10 code description
Mental and behavioural disorders: Schizophrenia, schizotypal and delusional disorders, Mood [affective] disorders, Neurotic, stress-related and somatoform disorders,Behavioural syndromes associated with physiological disturbances and physical factors, Di
Primary outcomes
1
Description
Level of engagement in occupation in Profile of Occupational Engagement in people with Severe mental illness
Timepoint
Before the start of the intervention, After the start of the intervention and 2 months after the intervention
Method of measurement
Profile of Occupational Engagement in people with Severe Mental Illness
Secondary outcomes
1
Description
Level of performance in Canadian Occupational Performance Measure
Timepoint
Before the start of the intervention, After the start of the intervention and 2 months after the intervention
Method of measurement
Canadian Occupational Performance Measure
2
Description
Level of satisfaction in Canadian Occupational Performance Measure
Timepoint
Before the start of the intervention, After the start of the intervention and 2 months after the intervention
Method of measurement
Canadian Occupational Performance Measure
Intervention groups
1
Description
Intervention group: The intervention period will be held for 2 months, two sessions a week for 3 hours. The intervention program for the implementation of the Clubhouse model is such that it creates a modified environment for people with mental problems to strengthen their confidence and ability to fully participate in society by joining it. Clubhouse program activities are done in groups and include cooking, artistic activities such as painting and drawing, etc., health services such as sports, administrative activities, accounting and maintenance of the center and working with computers. In addition to group activities, the participants are provided with individual support to make the activities meaningful, and the research team is also in contact with their family members and counseling is done if needed.
Category
Rehabilitation
2
Description
Control group: The sessions are held in the form of art education (painting, fabric design, ornamental bracelets and music...) and occupational therapy for two days a week during 2 months in 3-hour sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
occupational therapy in mental health of IUMS School of Rehabilitation Science
Full name of responsible person
Elahe Hojati Abed
Street address
school of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
13487 15459
Phone
+98 21 2222 7124
Email
elahe_hojati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
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
021-88622703
Phone
+98 21 8670 2504
Email
falak.r@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
Assistant Professor of occupational therapy
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
school of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 8051
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
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Occupational therapy departeman,School of Rehabilitation Sciences, Iran University of Medical Sciences Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
hojatiabed.e@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elahe Hojati Abed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Occupational therapy departeman,School of Rehabilitation Sciences, Iran University of Medical Sciences Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
hojatiabed.e@iums.ac.ir
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
Part of the data, such as information related to the main outcome, which is the level of employment in the occupational employment profile of chronic mental patients
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any use of the data is permitted provided that the principal investigator of the study is informed.
From where data/document is obtainable
Elaha Hojati Abed- Department of Occupational Therapy, School of Rehabilitation Sciences, Iran Medical Sciences- Email address
What processes are involved for a request to access data/document
6 months after the results are published, the applicant can receive a part of the data to the address specified by the main researcher by sending her/his request to the email address mentioned.