<?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>IRCT20220702055336N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of ACT (treatment based on acceptance and commitment) on marital commitment, social adjustment and resilience</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of ACT (treatment based on commitment and acceptance) on marital commitment, social adjustment and resilience of men with substance abuse (opioids)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64608</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: The randomization method is a simple randomization.  The study has two groups and from the beginning it is agreed that odd numbers will be given to the intervention group and even numbers will be given to the control group.  Then, using random numbers table, the relevant numbers are extracted, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope, and the first patient who entered the study  Envelope number 1, patient number 2, envelope number 2 and so on will be given.</study_design>
      <phase>N/A</phase>
      <hc_freetext>substance abuse (opioids).</hc_freetext>
      <i_freetext>Intervention 1: The number of 40 patients will be randomly selected and will be allocated in two intervention groups (20 people) and control group (20 people). At first, the intervention group will complete Adams and Jones marital commitment questionnaires, Professor Bell's social adjustment, Connor and Davidson's resilience as a pre-test, and only the intervention group will undergo treatment based on acceptance and commitment in 8 sessions of 90 minutes.  The summary of the sessions is as follows: First session: greeting and introduction of the group members to the therapist and to each other; expressing people's feelings before coming to the meeting; The reason for coming to this meeting and what they expect from the treatment sessions; Statement of previous similar experiences; Stating the rules that must be observed in the group, including: coming on time-not being absent (punctuality), doing tasks, etc.; Statement of the principle of confidentiality and mutual respect of group members to each other; stating the subject of the research and its objectives and stating this subject to think about the objectives; General presentation of educational materials regarding commitment and acceptance and its results; Conducting the pre-test. The second session: explanation and statement of the principle why the need for psychological interventions is felt?; creating hope and expectation of treatment in reducing these pressures; Expressing the principle of accepting and recognizing feelings and thoughts about problems, giving awareness in this field that thoughts as thoughts and;  accept feelings as feelings and memories only as memories;  Presentation of the assignment in the field of self-acceptance and feelings caused by problems. The third session: reviewing the tasks of the previous session;  Talking about the feelings and thoughts of the group members; Teaching the members to accept their thoughts and feelings without judging whether they are good or bad;  Education and recognition of emotions and their difference with thoughts and feelings;  Presenting the assignment of how much we accept ourselves and our feelings and how much we accept others and others' feelings? Fourth session: Examining tasks;  Presenting the technique of mindfulness and focusing on breathing;  Presenting the technique of being in the moment and stopping thinking;  Re-emphasis on the principle of acceptance in recognizing feelings and thoughts;  Emphasis on recognizing feelings and thoughts with another look;  Tasks: Look at life events (annoying) in a different way and do not stop addiction and imagine it only as a disease and not more. Fifth session: review of tasks;  Education and creation of knowledge about the difference between acceptance and surrender and awareness of the fact that we accept what we cannot change;  Recognizing the subject of judgment and encouraging members not to judge their feelings; Presenting this technique to be aware of the existence of their feelings by being mindful at every moment, just witnessing them but not judging them;  Presenting mindfulness homework along with non-judgmental acceptance. Sixth session: self-representation and short survey of the education process;  Asking the group members to express their feelings and emotions regarding the tasks of the previous meeting;  Teaching and presenting the principle of commitment and its necessity in the process of education and treatment;  (Education of commitment to action means that after choosing a valuable and right path in terms of reaching peace or accepting any event in life, let's act on it and commit ourselves to doing it);  Providing the technique of selective attention for more relaxation regarding the influx of negative spontaneous thoughts;  Rehearsing the seventh brainstorming session: providing feedback and searching for unresolved issues among group members;  Identifying behavioral plans regarding accepted matters and making a commitment to act on them;  Creating the ability to choose an action among different options, in a way that is more appropriate and not more practical. Awareness along with scanning in the eighth session: review of tasks;  Summary of contents;  Obtaining commitment from members to perform tasks after the end of the course;  Introducing yourself to the group members, appreciating and thanking them for their presence in the meetings. Finally, the post-test will be done. Intervention 2: Control group: The number of 40 patients will be randomly selected and will be allocated in two intervention groups (20 people) and control group (20 people). At the beginning, the control group completes Adams and Jones marital commitment questionnaires, Professor Bell's social adjustment, Connor and Davidson's resilience as a pre-test, and the control group will not receive treatment and the post-test will be administered at the end.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the possibility of publication of the article, no decision has yet been made to publish the data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Rouhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Corner of Panjam Alley, Muftah Township, Shahid Beheshti Beltway, Rasht.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146545157</zip>
        <telephone>+98 13 3352 5554</telephone>
        <email>dr.shadirohi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Rouhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Corner of Panjam Alley, Muftah Township, Shahid Beheshti Beltway, Rasht.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146545157</zip>
        <telephone>+98 13 3352 5554</telephone>
        <email>dr.shadirohi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20 to 40 years
married
Diploma and sub-diploma education</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Non-drug users
People outside the age limit
Reluctance to continue treatment</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The number of 40 patients will be randomly selected and will be allocated in two intervention groups (20 people) and control group (20 people). At first, the intervention group will complete Adams and Jones marital commitment questionnaires, Professor Bell's social adjustment, Connor and Davidson's resilience as a pre-test, and only the intervention group will undergo treatment based on acceptance and commitment in 8 sessions of 90 minutes.  The summary of the sessions is as follows: First session: greeting and introduction of the group members to the therapist and to each other; expressing people's feelings before coming to the meeting; The reason for coming to this meeting and what they expect from the treatment sessions; Statement of previous similar experiences; Stating the rules that must be observed in the group, including: coming on time-not being absent (punctuality), doing tasks, etc.; Statement of the principle of confidentiality and mutual respect of group members to each other; stating the subject of the research and its objectives and stating this subject to think about the objectives; General presentation of educational materials regarding commitment and acceptance and its results; Conducting the pre-test. The second session: explanation and statement of the principle why the need for psychological interventions is felt?; creating hope and expectation of treatment in reducing these pressures; Expressing the principle of accepting and recognizing feelings and thoughts about problems, giving awareness in this field that thoughts as thoughts and;  accept feelings as feelings and memories only as memories;  Presentation of the assignment in the field of self-acceptance and feelings caused by problems. The third session: reviewing the tasks of the previous session;  Talking about the feelings and thoughts of the group members; Teaching the members to accept their thoughts and feelings without judging whether they are good or bad;  Education and recognition of emotions and their difference with thoughts and feelings;  Presenting the assignment of how much we accept ourselves and our feelings and how much we accept others and others' feelings? Fourth session: Examining tasks;  Presenting the technique of mindfulness and focusing on breathing;  Presenting the technique of being in the moment and stopping thinking;  Re-emphasis on the principle of acceptance in recognizing feelings and thoughts;  Emphasis on recognizing feelings and thoughts with another look;  Tasks: Look at life events (annoying) in a different way and do not stop addiction and imagine it only as a disease and not more. Fifth session: review of tasks;  Education and creation of knowledge about the difference between acceptance and surrender and awareness of the fact that we accept what we cannot change;  Recognizing the subject of judgment and encouraging members not to judge their feelings; Presenting this technique to be aware of the existence of their feelings by being mindful at every moment, just witnessing them but not judging them;  Presenting mindfulness homework along with non-judgmental acceptance. Sixth session: self-representation and short survey of the education process;  Asking the group members to express their feelings and emotions regarding the tasks of the previous meeting;  Teaching and presenting the principle of commitment and its necessity in the process of education and treatment;  (Education of commitment to action means that after choosing a valuable and right path in terms of reaching peace or accepting any event in life, let's act on it and commit ourselves to doing it);  Providing the technique of selective attention for more relaxation regarding the influx of negative spontaneous thoughts;  Rehearsing the seventh brainstorming session: providing feedback and searching for unresolved issues among group members;  Identifying behavioral plans regarding accepted matters and making a commitment to act on them;  Creating the ability to choose an action among different options, in a way that is more appropriate and not more practical. Awareness along with scanning in the eighth session: review of tasks;  Summary of contents;  Obtaining commitment from members to perform tasks after the end of the course;  Introducing yourself to the group members, appreciating and thanking them for their presence in the meetings. Finally, the post-test will be done..</i_keyword>
      <i_keyword>Control group: The number of 40 patients will be randomly selected and will be allocated in two intervention groups (20 people) and control group (20 people). At the beginning, the control group completes Adams and Jones marital commitment questionnaires, Professor Bell's social adjustment, Connor and Davidson's resilience as a pre-test, and the control group will not receive treatment and the post-test will be administered at the end.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital commitment in Adams and Jones marital commitment questionnaire. Timepoint: At the beginning of the study and after the treatment. Method of measurement: Adams and Jones Marital Commitment Questionnaire.</prim_outcome>
      <prim_outcome>Social adjustment in Professor Bell's social adjustment questionnaire. Timepoint: At the beginning of the study and after the treatment. Method of measurement: Professor Bell's Social Adaptation 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>2022-06-19</approval_date>
        <contact_name>Ethics Committee of Tunkabon Islamic Azad University</contact_name>
        <contact_address>Mazandaran Province, Tonkabon, Kilometer 3 of Chalus Road Tunkabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
