<?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>IRCT20260902070889N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of acceptance and commitment therapy on reducing cravings and increasing psychological flexibility</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of acceptance and commitment therapy on reducing cravings and increasing psychological resilience in people with substance abuse.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of eligible subjects to the intervention and control groups will be simple random, using a random sequence generated by a random number table on the Randomization.com website. (To prepare a randomization list on the Randomization.com website, first enter the number of samples, the number of groups, and the type of randomization (such as block); then the website automatically generates a random list for assigning subjects to the research groups, which can be used in the sampling or subject assignment process.) This sequence is written in lowercase letters and kept in a sealed envelope. When each individual is selected, the envelope is opened and the individual is assigned to the counseling or control group according to the code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Opioid abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Session 1: Introduction and Creative HopelessnessIntroducing the group members, therapist, and objectives of the treatment sessionsExplaining the rules and framework of the sessionsAssessing the participants’ history of attempts to control craving, using questions such as: “What have you tried? What was the outcome?”Conducting the “Control Is the Problem” exerciseDiscussing the costs of experiential avoidance and attempts to control unpleasant internal experiencesSession 2: Acceptance and Contact with the Present MomentExplaining the concept of acceptance of internal experiencesTeaching and practicing mindful breathingConducting the “Sitting with Craving” exercise, with the aim of observing craving without acting upon itUsing the “Passengers on the Bus” metaphor to address thoughts related to substance useSession 3: Cognitive DefusionExplaining the concepts of cognitive fusion and cognitive defusionTeaching and practicing defusion exercises, including repeating thoughts in a cartoon voiceWriting thoughts on leaves and allowing them to drift awayPracticing “Labeling Thoughts” using the statement: “This is just a thought”Helping participants develop psychological distance from thoughts and beliefs associated with substance useSession 4: Self-as-ContextIntroducing the concept of self-as-contextUsing the “Sky and Weather” metaphor to illustrate the distinction between the observing self and thoughts and emotionsConducting the observer-self exercise and observing thoughts as clouds passing through the skyExplaining the distinction between the “conceptualized self” and the “observing self”Using the “Chessboard and Chess Pieces” metaphor to facilitate a better understanding of this conceptSession 5: ValuesClarifying participants’ fundamental life valuesIdentifying values that participants wish to pursue in a life free from substance use, such as family, work, and healthConducting the “Funeral/Eulogy” or “80th Birthday” exercise to identify and prioritize important life valuesExploring the distinction between values and goalsExamining the role of values in developing motivation for behavioral changeSession 6: Committed ActionEstablishing small, value-based goals using the SMART frameworkDeveloping plans for engaging in value-consistent actions despite the presence of craving and substance-related thoughtsConducting the “Small Steps” exerciseIdentifying potential barriers to behavioral changeStrengthening participants’ commitment to engaging in behaviors consistent with their personal valuesSession 7: Integrating ACT Processes and Craving ManagementReviewing the six core ACT processesConducting the comprehensive exercise of “Accepting Craving, Cognitive Defusion, and Value-Based Action”Role-playing and practicing responses to high-risk situations associated with substance useTeaching strategies for responding to lapsesReviewing participants’ experiences and strengthening their recommitment to the process of changePracticing the simultaneous use of acceptance, mindfulness, cognitive defusion, and values in real-life situationsSession 8: Review, Consolidation, and Follow-UpReviewing participants’ progress throughout the treatment sessionsReviewing and reinforcing the skills learned during treatmentReviewing and completing the final homework assignmentsDeveloping a relapse-prevention planAdministering the post-test assessmentSummarizing the overall treatment processConcluding the treatment and planning follow-up. Intervention 2: Control group: They do 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:
Study data, treatment protocol

When:
After publishing the articles

To whom:
All those interested in research in this field

Conditions:
Any type of analysis on the submitted data is permitted and acceptable with attribution of the source.

Where to obtain:
Via email to Ali Delfi at: ali_delfi@gmail.com

How to obtain:
Send an email to Ali Delfi and after approval by the research team members, the data will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Delfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Shahid Salman Pour Street, Bandaghir</address>
        <city>Shoshtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6147528963</zip>
        <telephone>+98 61 5919 8022</telephone>
        <email>ali_delfi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Delfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Shahid Salman Pour Street, Bandaghir</address>
        <city>Shoshtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6147528963</zip>
        <telephone>+98 61 5919 8022</telephone>
        <email>ali_delfi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of substance abuse or substance use disorder based on DSM-5-TR or diagnosis by a psychiatrist/psychologist
Being between 20 and 50 years old
At least 6 months of regular substance use history</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having an acute psychiatric disorder or requiring hospitalization prior to the study
Having a severe or debilitating physical illness
Taking psychiatric medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F11.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Opioid abuse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Session 1: Introduction and Creative HopelessnessIntroducing the group members, therapist, and objectives of the treatment sessionsExplaining the rules and framework of the sessionsAssessing the participants’ history of attempts to control craving, using questions such as: “What have you tried? What was the outcome?”Conducting the “Control Is the Problem” exerciseDiscussing the costs of experiential avoidance and attempts to control unpleasant internal experiencesSession 2: Acceptance and Contact with the Present MomentExplaining the concept of acceptance of internal experiencesTeaching and practicing mindful breathingConducting the “Sitting with Craving” exercise, with the aim of observing craving without acting upon itUsing the “Passengers on the Bus” metaphor to address thoughts related to substance useSession 3: Cognitive DefusionExplaining the concepts of cognitive fusion and cognitive defusionTeaching and practicing defusion exercises, including repeating thoughts in a cartoon voiceWriting thoughts on leaves and allowing them to drift awayPracticing “Labeling Thoughts” using the statement: “This is just a thought”Helping participants develop psychological distance from thoughts and beliefs associated with substance useSession 4: Self-as-ContextIntroducing the concept of self-as-contextUsing the “Sky and Weather” metaphor to illustrate the distinction between the observing self and thoughts and emotionsConducting the observer-self exercise and observing thoughts as clouds passing through the skyExplaining the distinction between the “conceptualized self” and the “observing self”Using the “Chessboard and Chess Pieces” metaphor to facilitate a better understanding of this conceptSession 5: ValuesClarifying participants’ fundamental life valuesIdentifying values that participants wish to pursue in a life free from substance use, such as family, work, and healthConducting the “Funeral/Eulogy” or “80th Birthday” exercise to identify and prioritize important life valuesExploring the distinction between values and goalsExamining the role of values in developing motivation for behavioral changeSession 6: Committed ActionEstablishing small, value-based goals using the SMART frameworkDeveloping plans for engaging in value-consistent actions despite the presence of craving and substance-related thoughtsConducting the “Small Steps” exerciseIdentifying potential barriers to behavioral changeStrengthening participants’ commitment to engaging in behaviors consistent with their personal valuesSession 7: Integrating ACT Processes and Craving ManagementReviewing the six core ACT processesConducting the comprehensive exercise of “Accepting Craving, Cognitive Defusion, and Value-Based Action”Role-playing and practicing responses to high-risk situations associated with substance useTeaching strategies for responding to lapsesReviewing participants’ experiences and strengthening their recommitment to the process of changePracticing the simultaneous use of acceptance, mindfulness, cognitive defusion, and values in real-life situationsSession 8: Review, Consolidation, and Follow-UpReviewing participants’ progress throughout the treatment sessionsReviewing and reinforcing the skills learned during treatmentReviewing and completing the final homework assignmentsDeveloping a relapse-prevention planAdministering the post-test assessmentSummarizing the overall treatment processConcluding the treatment and planning follow-up</i_keyword>
      <i_keyword>Control group: They do not receive any training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Substance abuse. Timepoint: At the start of the intervention, 2 weeks after the intervention, 8 weeks after the intervention, 2 months after the end of the intervention. Method of measurement: Drug Use Propensity Questionnaire by Franken et al. (2002).</prim_outcome>
      <prim_outcome>Psychological flexibility. Timepoint: At the start of the intervention, 2 weeks after the intervention, 8 weeks after the intervention, 2 months after the end of the intervention. Method of measurement: Personalized Psychological Flexibility Questionnaire by Kashden et al. (2020).</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>2026-05-26</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Southern Kargar Boulevard, Culture City, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
