Protocol summary
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Study aim
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Determining of the effectiveness of group narrative therapy on craving and relapse rates of addicts treating with methadone maintenance therapy
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Design
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The clinical trial for the control group is a single blind, with a sample population consisting of two groups of 64 people treated with methadone.The randomization method is a simple randomization method using sealed envelopes.
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Settings and conduct
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The study is conducted in one addiction treatment center in Garmsar, Semnan, Iran. Participants complete the relapse Prediction Scale (RPS) before the first group therapy session, in the last session, and one month later for follow-up. During this period, the slip behavior of the participants in each group is controlled according to the results of the urine test once a week without prior notice, when patients come to receive the daily dose of methadone. the present study is single blinded and data analyzer does not know the purpose and details of the research, and analyses the final data, impartially.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : the person should be treated with methadone for at a minimum of 3 months and at a maximum of 6 months , , absence of an acute physical illness and clinical psychiatric disorder, minimum education level of junior middle school Exclusion criteria:being under psychiatric treatment , other substance use disorder
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Intervention groups
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Subjects with the inclusion criteria are randomly assigned to two groups, including a group narrative therapy and a control group. The treatment group attends group narrative therapy sessions once a week for 10 weeks, and the control group does not receive any treatment.
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Main outcome variables
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craving , relapse rate
General information
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Reason for update
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due to the completing of the target sample size and generalizability of the results , the person should be treated with methadone for at a minimum of 3 months and 18 to 50 age range is considered
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210208050299N1
Registration date:
2021-02-21, 1399/12/03
Registration timing:
prospective
Last update:
2021-04-29, 1400/02/09
Update count:
1
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Registration date
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2021-02-21, 1399/12/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-09, 1399/12/19
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Expected recruitment end date
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2021-03-20, 1399/12/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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effectiveness of group narrative therapy on craving and relapse rates of addicts treating with methadone maintenance therapy in comparison with control group
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Public title
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The effect of Group Narrative Therapy in addiction
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Interest in participating in research, and full observance of health protocols (social distancing, masking in group meetings, and hand washing before and after the meeting),
the person should be treated with methadone for at a minimum of 3 months
Age range 18 to 50
history of opioid use disorder (including opium and heroin )
absence of an acute physical illness and clinical psychiatric disorder
minimum education level of junior middle school.
Exclusion criteria:
Reluctance to participate in research, and non-observance of health protocols
presence of physical illness that affects psychotherapy
being under psychiatric treatment (receiving psychotherapy or pharmachotherapy)
suicidal ideation
other substance use disorder
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Age
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From 18 years old to 50 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method is a simple randomization using random allocation software
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In the present study, data analyzer does not know the purpose and details of the research, and analyses the final data, impartially.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-02, 1399/09/12
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1399.668
Health conditions studied
1
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Description of health condition studied
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Addiction
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ICD-10 code
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F19
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ICD-10 code description
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Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
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Description
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craving
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Timepoint
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Before the intervention, the last meeting of the intervention and 1 Month after intervention
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Method of measurement
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relapse prediction scale ( RPS)
2
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Description
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relapse rate
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Timepoint
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Before the intervention, the last meeting of the intervention and 1 Month after intervention
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Method of measurement
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relapse prediction scale ( RPS)
Secondary outcomes
1
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Description
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relapse
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Timepoint
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once a week
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Method of measurement
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opium test
Intervention groups
1
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Description
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Group intervention:First session: Introduction and giving self-assessment tests and the story of participant's life , obtaining valuable insights about the narrative therapy and assigning homework ( Determining people's objectives and needs to change and being committed to work on their depression during their addiction to amphetamines )Second session: Started by externalization of problem and reviewing the effects of dominate story of people's life, asked them to create " my life story ", identifying first assumptions about self, teaching the way to revise ABCs every day and write them in a daily and assigning homework Third session: Started by checking homework, mind and body relaxation, improving eye contact skills, keep on everyday ABCs revisions and assigning homework.Fourth session: Checking homework, identifying the basic assumptions about addiction with group discussion on topic, training the way to create a new internal voice related to the basic assumption, continuing the practice of mind and body relaxation and other practices like asking them to paint their assumption about addiction and gave name to that, assigning homework Fifth session: Checking homework, training the way to identify addiction and group discussion on topic, teaching corrective thinking and adding D and E to ABCs, assigning homework Sixth session: Checking homework, training the way to change problematic behavioral pattern, using exposure techniques and response prevention and using techniques such as procrastination, diaphragm respiration, overcoming time, and assigning homework (using new behavioral techniques in different situations).Seventh session: Checking homework, setting up satisfactory relationship with self such as writing a letter and apologizing to self, writing positive points about self, and doing activities regarding health, fitness, stimulating activities like five senses and activities related to physical appearance, and assigning homework Eighth session: Started by group discussion about individual's feelings, desires and dreaming about themselves and assigning home work (to create a best story about self and rewriting the life story from past to future).Ninth session: Checking homework, Rewriting life story about now and future and give a new name to that , relaxation , teaching about how to create new story and individual helps, assigning homework (reviewing all sessions and finding best and worst parts of that).Tenth session: Checking homework, group discussion about the changes that have happened due to the sessions , the second investigation of self-assessment tests , identifying attitudes, training the assertive strategies to people
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Category
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Behavior
2
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Description
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Control group: Does not receive any intervention
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Only part of the data, such as the original outcome information, is shared
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When the data will become available and for how long
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Get started 6 months after printing results
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Documentation can be used to carry out new studies
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From where data/document is obtainable
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Refer to the corresponding author after publication
mehdi.derakhshani74@gamil.com
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What processes are involved for a request to access data/document
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After reviewing the application, will be provided by the corresponding author
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Comments
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