<?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>IRCT20220520054933N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of effectiveness of cognitive-behavioral therapy and therapy based on commitment and acceptance on coping strategies with stress, feeling of psychological cohesion and intimacy of couples in opioid addicts under methadone maintenance treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of cognitive-behavioral therapy and therapy based on commitment and acceptance on coping strategies with stress, feeling of psychological cohesion and intimacy of couples in opioid addicts under methadone maintenance treatmen</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63799</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample consisted of 60 opiate addicts treated with methadone in 3 months of summer 1401 with inclusion criteria and available sampling of 60 people and in the form of simple random allocation so that the samples are numbered and entered in Excel software from 1 to 60, respectively. And then with the data analysis plugin sampling tools the numbers are accidentally messed up and From row 1 to 20, an intervention group from row 21 to 40 will be placed in an intervention group and from row 41 to 60 of the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>opioid addicts under methadone maintenance treatment.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: cognitive behavioral therapy, by teaching the techniques and principles of this therapy in 12 sessions, we help patients to understand the thoughts and feelings that affect their behavior. Intervention 2: The second intervention group: therapy based on commitment and acceptance, which consists of 4 approaches: awareness, acceptance, commitment, and behavior change, and in 12 sessions, by teaching related principles and techniques, we try to create people's psychological flexibility in such a way that they need It is not to remove or eliminate the bad feeling, but despite the existence of this feeling, the person should move towards value-based behavior. Intervention 3: Control group: no training to the subjects, who during these 12 sessions that are taught to the two intervention groups, this group does not receive any training.</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:
The raw data file extracted from the questionnaires
Statistical data analysis file

When:
The access period starts 8 months after the results are published

To whom:
Only for researchers and employees in academic institutions

Conditions:
In order to use these data during communication, necessary arrangements are made regarding the permitted analysis.
They can only be used for academic research

Where to obtain:
They can make necessary arrangements to receive data by sending emails and communicating.
ُSaleh.g1992@gmail.com
09132479877

How to obtain:
After the request is made by the applicant and confirmation is received from the supervisor, the data file is sent via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saleh Ghiasi Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 37, Alley 45, North Obzar Street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617773793</zip>
        <telephone>+98 34 3251 4448</telephone>
        <email>Saleh.g1992@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alireza Manzari Tavakoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman Branch, Islamic Azad University, Waliasr Blvd.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7635168111</zip>
        <telephone>+98 34 3321 0043</telephone>
        <email>a.manzari@iauk.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Low score in the problem-oriented coping strategies questionnaire
Low score on the couple intimacy questionnaire
Low score on the Mental Cohesion Questionnaire
Absence of psychotic and paranoid disorders in subjects
Receive voluntary and informed consent
At least a year has passed since their addiction
People addicted to methadone maintenance treatment
Have at least a diploma
Married</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Single
illiterate
Substance dependent individuals treated with other treatments than methadone
People with psychotic and paranoid disorders
High score in psychological coherence questionnaire
High score in couple intimacy questionnaire
A high score in the problem-oriented stress coping strategies questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Opioid related disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: cognitive behavioral therapy, by teaching the techniques and principles of this therapy in 12 sessions, we help patients to understand the thoughts and feelings that affect their behavior.</i_keyword>
      <i_keyword>The second intervention group: therapy based on commitment and acceptance, which consists of 4 approaches: awareness, acceptance, commitment, and behavior change, and in 12 sessions, by teaching related principles and techniques, we try to create people's psychological flexibility in such a way that they need It is not to remove or eliminate the bad feeling, but despite the existence of this feeling, the person should move towards value-based behavior</i_keyword>
      <i_keyword>Control group: no training to the subjects, who during these 12 sessions that are taught to the two intervention groups, this group does not receive any training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>People's scores in Endler's stress coping strategies questionnaire. Timepoint: Measuring stress coping strategies at the beginning of the study and after 12 weeks at the end of the intervention. Method of measurement: Endler's stress coping strategies questionnaire.</prim_outcome>
      <prim_outcome>People's scores in the Flensberg Coherence Questionnaire. Timepoint: Measuring the sense of psychological coherence at the beginning of the study and after 12 weeks at the end of the intervention. Method of measurement: Flensberg sense of coherence questionnaire.</prim_outcome>
      <prim_outcome>People's scores in the Walker and Thomson Marital Intimacy Questionnaire. Timepoint: Measuring the feeling of marital intimacy at the beginning of the study and after 12 weeks at the end of the intervention. Method of measurement: Walker and Thomson Marital Intimacy Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-20</approval_date>
        <contact_name>Research ethics committee of Islamic Azad University, Kerman branch</contact_name>
        <contact_address>No. 37, Alley 45, North Obzar Street Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
