<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210208050299N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Group Narrative Therapy in addiction</public_title>
      <acronym></acronym>
      <scientific_title>effectiveness of group narrative  therapy on craving and relapse rates of addicts treating with methadone maintenance therapy in comparison with control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method is a simple randomization using random allocation software, Blinding description: In the present study, data analyzer does not know the purpose and details of the research, and analyses the final data, impartially.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Addiction.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: Control group: Does not receive any intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as the original outcome information, is shared

When:
Get started 6 months after printing results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Documentation can be used to carry out new studies

Where to obtain:
Refer to the corresponding author after publication
mehdi.derakhshani74@gamil.com

How to obtain:
After reviewing the application, will be provided by the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi.Derakhshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 , Sahid ozhagi street , Garmsar , Semnan</address>
        <city>Garmsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35493-35831</zip>
        <telephone>+98 23 3455 4217</telephone>
        <email>mehdi.derakhshani74@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi.Derakhshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 , Sahid ozhagi street , Garmsar , Semnan</address>
        <city>Garmsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35493_35831</zip>
        <telephone>+98 23 3455 4217</telephone>
        <email>mehdi.derakhshani74@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <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.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to psychoactive substance use</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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</i_keyword>
      <i_keyword>Control group: Does not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Craving. Timepoint: Before the intervention, the last meeting of the intervention and 1 Month after intervention. Method of measurement: relapse prediction scale ( RPS).</prim_outcome>
      <prim_outcome>Relapse rate. Timepoint: Before the intervention, the last meeting of the intervention and 1 Month after intervention. Method of measurement: relapse prediction scale ( RPS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Relapse. Timepoint: once a week. Method of measurement: opium test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-02</approval_date>
        <contact_name>Research Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>13th floor , Block A, Treatment and Medical Education, Iran TV St. - Headquarters of the Ministry of Health, between South Flamek and ZarafshanGhods town (west) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
