Investigation the effect of occupational therapy intervention in area of leisure on occupational performance and balance in abstinent person with substance use disorders
Investigation the effect of occupational therapy intervention in area of leisure on occupational performance and balance in abstinent person with substance use disorders
Design
The clinical trial is a single blind , with parallel groups, and divided into two groups as a block randomization.
Settings and conduct
The interventions will be implemented in a group and within a period of 2 months. According to the nature of the interventions, and if necessary facilities are available, recreation centers (Enghelab Cultural and Sports Complex) are the main place to provide these interventions.
Participants/Inclusion and exclusion criteria
1- Absence of central nervous system diseases
2- Minimum period of abstinence from any substance and alcohol for a period of 15 days
3- Age range of 18-50 years
4- Absence of any psychiatric diagnosis based on DSM-5 diagnostic criteria
5- Absence of obvious movement problems
6- No history of head injury with loss of consciousness or seizures
7- Not taking drugs that disrupt the central nervous system
Intervention groups
1- Conventional interventions :which are usually the administration of agonist drugs such as methadone and buprenorphine. There will also be regular medical and psychological counseling sessions.
2- Leisure time interventions: In this intervention method, the leisure-based intervention group is presented with a list of leisure occupations and asked to choose the ones of interest. The selected leisure will be considered as therapeutic interventions and will be carried out according to the schedule.
Main outcome variables
1- Occupational balance, which is an experience of having a sufficient amount (neither too much nor too little) of occupation in sufficient variety that is accompanied by a feeling of satisfaction in the individual.
2- Occupational performance, which is the level of participation of a person in daily life occupations.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010806N11
Registration date:2023-02-28, 1401/12/09
Registration timing:retrospective
Last update:2023-02-28, 1401/12/09
Update count:0
Registration date
2023-02-28, 1401/12/09
Registrant information
Name
Malahat Akbarfahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
akbarfahimi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of occupational therapy intervention in area of leisure on occupational performance and balance in abstinent person with substance use disorders
Public title
leisure and substance use disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of central nervous system diseases (stroke, multiple sclerosis, Parkinson's, etc., according to observations and medical records)
Minimum period of abstinence from any substance and alcohol for a period of 15 days
Age range of 18-50 years
Absence of any psychiatric diagnosis based on DSM-5 diagnostic criteria
Absence of obvious movement problems (according to observation and medical record)
No history of head injury with loss of consciousness or seizures (according to observation and medical record)
Not taking drugs that disrupt the central nervous system (medical history and doctor's confirmation)
Exclusion criteria:
Substance abuse
The person's unwillingness to answer questions or attend the intervention session
Receive cognitive rehabilitation treatments at the same time
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. In this clinical trial, we will have blocks of equal size (blocks of 4 including 2 people in the conventional treatment group, 2 people in the leisure-based intervention). All the people in the two groups received the conventional interventions of addiction treatment centers, while the second group also received leisure timed interventions. At first, 4 blocks were prepared as (AABB, ABAB, ABBA, BBAA, BABA, BAAB). Then 12 of these blocks are randomly selected and people are assigned to two groups B and A; And this work continues until the completion of the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator in all three stages of evaluation (before interventions, after interventions and follow-up) is unaware of the study groups. The research team and the participants are aware of the research 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 of Medical Sciences
Street address
Hemmat highway, next to the milad hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.IUMS.REC.1401.623
Health conditions studied
1
Description of health condition studied
Substance use disorders
ICD-10 code
F19.1
ICD-10 code description
Other psychoactive substance abuse
Primary outcomes
1
Description
occupational balance score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Occupational balance questionnaire
2
Description
occupational performance score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Occupational performance questionnaire
Secondary outcomes
1
Description
leisure score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Leisure time questionnaire
2
Description
Quality of life score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Quality of life questionnaire(36-Item Short-Form Health Survey)
3
Description
drug craving score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Drug desire questionnaire
4
Description
Executive function score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Dysexecutive questionnaire
5
Description
Time management score
Timepoint
1- Before the start of the intervention, 2- After the end of the interventions, 3- After the two-month follow-up period
Method of measurement
Assessment of Time management skills questionnaire
Intervention groups
1
Description
Control group: This group receives the conventional interventions of drug cessation centers. Treatment measures of withdrawal centers in our country are usually prescription of agonist drugs such as methadone and buprenorphine to reduce withdrawal symptoms and drug cravings. Also, weekly medical and psychological consultation and examination sessions will be held for this group. During this research, there will be no interference in these interventions and the participants will take medicine according to the doctor's order and will participate in their meetings in the weekly schedule.
Category
Rehabilitation
2
Description
Intervention group: In addition to the conventional interventions of drug cessation centers, this group also receives leisure time interventions. The aim of leisure time intervention is to provide occupation in order to improve the individual's performance. In this intervention method, a list of leisure occupations is presented and they are asked to select the ones they like. The selected cases will be considered as therapeutic interventions and will proceed according to the schedule. The steps of designing and carrying out leisure time interventions are as follows: 1- Preparation of the list of leisure time occupations: In order to prepare the list of leisure time occupations, a library study will be done to check the available evidence and documentation in the field of types and ways of implementing leisure time occupations. Also, the results of the evaluations (Nottingham Leisure Questionnaire) are used to check people's leisure time interests. After gathering the information, the opinions of experts will be considered during meetings to finalize the leisure activities. In addition to the mentioned cases, the results of the qualitative evaluation of the research participants (results from the interview and the COPM test) will be considered in choosing the final list of leisure occupations. It is attempted that as much as possible the leisure occupations presented in the final list are socially and culturally acceptable, accessible, affordable, feasible and safe. 2- Selection of occupations: After preparing the final list of leisure time occupations, during a group meeting with the presence of all members of the intervention group, 9 occupations agreed upon by the group members will be selected as intervention. Elections will be based on the number of people's votes, and any activity that has the majority vote will be selected as an intervention. Finally, a table to specify the time and place of these interventions is compiled and adjusted with the consensus of all members of the intervention group and is provided to the people. 3- How to carry out the intervention: after choosing the occupations (interventions) and scheduling them, the implementation phase begins. The number of intervention sessions is 12, sessions 1, 2 and 12 will be in person or online and in line with education, and in the other 9 sessions The group does their chosen leisure activity. The interventions will be implemented in a group and within a period of 2 months. According to the nature of the interventions, and if necessary facilities are available, recreation centers (enghelab Cultural and Sports Complex) are the main place to provide these interventions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Chavan Occupational Therapy Center
Full name of responsible person
Zahra Morovati
Street address
Mellat Square, Shamsabad, No 238
City
Tehran
Province
Tehran
Postal code
1673816111
Phone
+98 21 2624 4681
Email
zmorovati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Moosavi
Street address
Hemmat Highway, between Chamran and Sheikh Fadlallah, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Email
akbarfahimi.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
Dr. Malahat Akbafahimi
Position
Master degree Occupational therapy- PhD of Cognitive neuroscience Science
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad,Mohseni squre, Shahnazari street, Madadkaran street,Faculty of Rehabilitation Science
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 7124
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malahat Akbarfahimi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Hemmat Highway, between Chamran and Sheikh Fadlallah - Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
akbarfahimi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malahat Akbarfahimi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Hemmat Highway, between Chamran and Sheikh Fadlallah - Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
akbarfahimi.m@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the end of the study, all data can be shared after de-identifying people.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
The data will be available to researchers of academic and scientific institutions.
Under which criteria data/document could be used
If possible, further statistical analysis of the data will be available .
From where data/document is obtainable
Dear Mrs. Dr. Malahat Akbarfahimi. Iran University of Medical Sciences - Faculty of Rehabilitation - Department of Occupational Therapy
What processes are involved for a request to access data/document