Protocol summary
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Study aim
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1. Determining of the effectiveness of group narrative therapy on depression, anxiety, recurrence, quality of life and life expectancy of Addicted People to Amphetamines. 2. Compare the effectiveness of group narrative therapy with the control group on depression, anxiety, recurrence, quality of life and life expectancy Addicted People to Amphetamines
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Design
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clinical trial with control group, Case Study Community included 30 Addicted People to Amphetamines, The subjects are randomly divide into two groups, Randomization method is a simple randomization using lottery. The intervention group undergoes 10 sessions of group narrative therapy for 10 weeks.
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Settings and conduct
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The location of the study is Farabi Hospital in Kermanshah. Study subjects complete Beck depression inventory-II, Beck anxiety inventory-II, quality of life, recurrence and life expectancy questionnaires before the first treatment session, the last session of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Earn equivalent score Low depression (Score between 14 to 19) in Beck depression inventory(BDI-II) ; Having The age range of 20 to 55 years; Having at least a high school Education guide; Full satisfaction to participate in the research and signing Informed consent form and written. Exclusion criteria: Acquisition no depression or minimal scores in the BDI-II ; Having physical problems that interfere in psychotherapy; Get psychiatric treatment or other psychotherapy at the same time; Having Suicidal thoughts
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Intervention groups
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Subjects were randomly divided into two groups, an experimental group narrative therapy and a control group. The intervention group is required to attend group narrative therapy sessions for 10 weeks and once a week and the control Group does not receive any intervention.
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Main outcome variables
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Depression, anxiety, quality of life, Recurrence and life expectancy
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016010425442N2
Registration date:
2016-02-28, 1394/12/09
Registration timing:
prospective
Last update:
2018-06-21, 1397/03/31
Update count:
1
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Registration date
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2016-02-28, 1394/12/09
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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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Kermanshah University of Medical Sciences
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Expected recruitment start date
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2016-01-21, 1394/11/01
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Expected recruitment end date
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2016-04-20, 1395/02/01
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Actual recruitment start date
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2016-04-03, 1395/01/15
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Actual recruitment end date
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2016-09-22, 1395/07/01
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Trial completion date
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empty
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Scientific title
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The effectiveness of Group Narrative Therapy on depression, anxiety, recurrence, life expectancy and quality of life people addicted to amphetamine compared 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:
Earn equivalent score Low depression (Score between 14 to 19) in Beck depression inventory (BDI-II)
Having The age range of 20 to 55 years
Having at least a high school Education guide
Full satisfaction to participate in the research and signing Informed consent form and written
Exclusion criteria:
Earn equivalent score no depression or minimum depression in Beck depression inventory (BDI-II)
Having physical problems that interfere with psychotherapy
Receive simultaneous Psychiatric or other psychotherapy
Having suicidal thoughts
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Age
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From 20 years old to 55 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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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
26
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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 lottery.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2015-11-24, 1394/09/03
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Ethics committee reference number
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KUMS.REC.1394.201
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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F15
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ICD-10 code description
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Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
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Description
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Depression
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Timepoint
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Before the intervention and the last meeting of the intervention
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Method of measurement
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Beck depression inventory (BDI-II)
2
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Description
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Anxiety
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Timepoint
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Before the intervention and the last meeting of the intervention
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Method of measurement
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Beck anxiety inventory-II
3
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Description
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Recurrence
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Timepoint
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Before the intervention and the last meeting of the intervention
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Method of measurement
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Recurrence Questionnaire
4
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Description
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Quality of Life
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Timepoint
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Before the intervention and the last meeting of the intervention
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Method of measurement
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Quality of Life Questionnaire
5
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Description
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Life expectancy
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Timepoint
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Before the intervention, the last meeting of the intervention and one month after the end of intervention
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Method of measurement
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Life Expectancy Questionnaire
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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Kermanshah 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
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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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