<?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>IRCT20210111050000N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of ACT and DBT with and without exercise on the core and psychological indicators of chronic pain and improving adherence to substance abuse</public_title>
      <acronym></acronym>
      <scientific_title>Core and Psychological Indicators of Chronic Pain, Coping Strategies and Treatment Adherence in the Effectiveness of Acceptance and Commitment Therapy(ACT) and Dialectical Behavior Therapy(DBT) Interventions with and without exercise activities in Substance Dependent Patients with chronic pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53621</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: From the list of addiction treatment centers for men in Zahedan, select two centers in a cluster method and after a diagnostic interview and test and determine patients suffering from chronic pain,Using a random number table, they were placed in four groups of 15 interventions (ACT with exercise and ACT without exercise) and (DBT with exercise and DBT without exercise) and a group of 15 controls and after performing the pre-test, they were exposed to the effects of variables. We are independent.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: People who receive acceptance and commitment therapy (ACT) with exercise. Intervention 2: Intervention group 2: People who receive acceptance and commitment therapy (ACT) without exercise. Intervention 3: Intervention group 3: People who receive dialectical behavior therapy (DBT) with exercise. Intervention 4: Intervention group 4: People who receive dialectical behavior therapy (DBT) without exercise. Intervention 5: Control group:People who do 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:
After studying, it will be possible to access information related to the main outcome of the research.

When:
One year after the results are published

To whom:
Students, professors, researchers and clinicians

Conditions:
Data should be requested with the aim of improving the level of research or clinical interventions.

Where to obtain:
postal code 9816647446,No.,6, Qalanbar Blv, Zahedan city
abbasali.ovisi@gmail.com

How to obtain:
The request will be sent by e-mail and will be answered within one month after receiving the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbasali Oveisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Between 6 and 8.; Qalanbar Blvd.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816647446</zip>
        <telephone>+98 54 3344 0323</telephone>
        <email>abbasali.ovisi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbasali Oveisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Between 6 and 8.; Qalanbar Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816647446</zip>
        <telephone>+98 54 3344 0323</telephone>
        <email>abbasali.ovisi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>They complete the detoxification treatment and stay at the beginning of the maintenance treatment period.
Lack of chronic pain due to an obvious problem such as infection or bone fracture and ...
No serious psychiatric illness (diagnosis by DSM-5 diagnostic interview)
Obtaining a score in the Chronic Pain Diagnosis Questionnaire and confirming the chronic pain by the treating physician
They complete the detoxification treatment and stay at the beginning of the maintenance treatment period
Do not take psychotropic drugs during interventions
Failure to attend other sessions of psychotherapy and the Association of Anonymous Addicts</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Dissatisfaction with continuing to participate in treatment sessions
Absence from more than two sessions and discontinuation of addiction treatment
Creating physical problems during the period that require hospitalization</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pain syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: People who receive acceptance and commitment therapy (ACT) with exercise</i_keyword>
      <i_keyword>Intervention group 2: People who receive acceptance and commitment therapy (ACT) without exercise</i_keyword>
      <i_keyword>Intervention group 3: People who receive dialectical behavior therapy (DBT) with exercise.</i_keyword>
      <i_keyword>Intervention group 4: People who receive dialectical behavior therapy (DBT) without exercise.</i_keyword>
      <i_keyword>Control group:People who do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduce chronic pain. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Chronic Pain Case Test.; Asghari Moghadam (1995).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Catastrophic reduction of chronic pain. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Pain Catastrophe Questionnaire (Sullivan, Bishop and Pewick, 1995).</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Center for Epidemiological Studies Short Depression Scale(CES-D).</sec_outcome>
      <sec_outcome>Pain coping strategies. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Coping Strategies Questionnaire.</sec_outcome>
      <sec_outcome>Chronic Pain Acceptance. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Chronic Pain Acceptance Questionnaire.</sec_outcome>
      <sec_outcome>Reduce cravings. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Craving test (Franken, Hendrix and Vandenbrink, 2002).</sec_outcome>
      <sec_outcome>Readiness to change and adhere to treatment. Timepoint: Before the intervention and immediately after the intervention and 2 months after the intervention. Method of measurement: Scale Stage of Readiness for Change and the Desire to Treat Addiction.</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>2021-02-08</approval_date>
        <contact_name>Etics committee of Birjand Univercity</contact_name>
        <contact_address>between 6 and 8, Qalanbor Blvd, Zahedan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
