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IRCT20120910010806N11 IRCT 2023-02-28 Iran University of Medical Sciences leisure and 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 2023-01-21 anticipated 40 Complete https://irct.ir/trial/66699 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Substance use disorders. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: After the end of the study, all data can be shared after de-identifying people. When: The access period will start 6 months after the results are published. To whom: The data will be available to researchers of academic and scientific institutions. Conditions: If possible, further statistical analysis of the data will be available . Where to obtain: Dear Mrs. Dr. Malahat Akbarfahimi. Iran University of Medical Sciences - Faculty of Rehabilitation - Department of Occupational Therapy How to obtain: Sending an e-mail to Dr. Malahat Akbarfahimi. Comments:
public Dr. Malahat Akbafahimi
Mirdamad,Mohseni squre, Shahnazari street, Madadkaran street,Faculty of Rehabilitation Science
Tehran Iran (Islamic Republic of) 15875-4391 +98 21 2222 7124 akbarfahimi.m@iums.ac.ir Iran University of Medical Sciences scientific Malahat Akbarfahimi
Hemmat Highway, between Chamran and Sheikh Fadlallah - Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 akbarfahimi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 50 years Both Substance abuse The person's unwillingness to answer questions or attend the intervention session Receive cognitive rehabilitation treatments at the same time F19.1 Other psychoactive substance abuse Rehabilitation Rehabilitation 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. 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. 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. 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. 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. 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). 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. 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. 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. Iran University of Medical Sciences Approved 2022-11-02 Ethics committee of Iran University of Medical Sciences Hemmat highway, next to the milad hospital Tehran Tehran Iran (Islamic Republic of)