<?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>IRCT20260920071126N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-24</date_registration>
      <primary_sponsor>Islamic Azad University, Semnan Branch</primary_sponsor>
      <public_title>The Effect of Unified Transdiagnostic Interventions on Experiential Avoidance, Emotion Regulation, and Treatment Sustainability in Individuals Undergoing Substance Abuse Treatment</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Unified Transdiagnostic Interventions on Experiential Avoidance, Emotion Regulation, and Treatment Sustainability in Individuals Undergoing Substance Abuse Treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93523</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, eligible individuals will be randomly assigned to either the intervention or control group following initial assessments. A simple randomization method will be employed for this purpose. First, each participant will be assigned a unique identification number. These numbers will then be entered into the Random Allocation Software (RAS) to randomly assign participants to the intervention or control group. To maintain the independence of the allocation process and minimize the risk of bias, randomization will be performed by an individual independent of the intervention implementation team. This approach ensures that every participant has an equal chance of being assigned to either group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Opioid abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group undergoes an integrated transdiagnostic intervention consisting of eight weekly, 90-minute sessions. This intervention is designed to reduce experiential avoidance, improve emotion regulation, and enhance treatment durability. The sessions focus on increasing individuals' awareness of their emotional experiences, thoughts, and behavioral patterns, as well as identifying maladaptive emotion regulation strategies. Subsequently, using transdiagnostic techniques, participants are taught skills related to acceptance and emotional exposure, the reduction of experiential avoidance, emotion regulation, and the modification of maladaptive patterns. In the final sessions, the acquired skills are reviewed, with an emphasis on consolidating and applying them in daily life and situations relevant to the treatment process. Intervention 2: Control group: Participants in this group will not receive any intervention from the researcher during the study and will simply benefit from the center's standard treatment services. No additional therapeutic or educational sessions will be conducted for this group, and their routine treatment process will continue unchanged.</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:
All data will be available for sharing after the removal of participants’ identifying information and confirmation that the data are fully anonymized.

When:
The data can be made available one week after the results are published.

To whom:
The data and documentation from this study will be accessible exclusively to researchers and specialists in fields related to substance abuse, psychology, behavioral sciences, and the treatment of substance use disorders who are affiliated with academic institutions, research centers, and reputable scientific organizations.

Conditions:
The data and documentation may be used for study or research purposes, provided the source is cited.

Where to obtain:
If the data is required, please contact fateme.shahjuiee@iau.ir via email.

How to obtain:
Upon receipt and review of the request by the principal investigator, the data—accompanied by an undertaking not to publish the data without the principal investigator's name—will be sent to the requester within a maximum of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shahjouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 911, 20th East St., Damavand Square, Raziyeh Town</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519955563</zip>
        <telephone>+98 23 3342 1655</telephone>
        <email>fateme.shahjuiee@iau.ir</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahab Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Faculty of Humanities, Islamic Azad University, University Campus, Semnan, Iran.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>Shahab.moradi@iau.ac.ir</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Visiting and receiving treatment services at substance abuse treatment centers in the city of Semnan.
Ages 18 to 60
Diagnosis of substance use disorder based on medical records
At least one month of history receiving maintenance therapy
Stability of physical and mental condition at the time of enrollment in the study
Informed consent and willingness to participate in research
Ability to comprehend material and complete research instruments
Possessing the readiness and ability to attend intervention sessions regularly</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from severe psychiatric disorders such as psychosis or severe bipolar disorder
Presence of cognitive impairment or intellectual disability affecting the understanding and implementation of the intervention
Urgent need for hospitalization or specialized psychiatric services
Concomitant use of substances or medications that significantly affect an individual's cognitive and emotional state.</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group undergoes an integrated transdiagnostic intervention consisting of eight weekly, 90-minute sessions. This intervention is designed to reduce experiential avoidance, improve emotion regulation, and enhance treatment durability. The sessions focus on increasing individuals' awareness of their emotional experiences, thoughts, and behavioral patterns, as well as identifying maladaptive emotion regulation strategies. Subsequently, using transdiagnostic techniques, participants are taught skills related to acceptance and emotional exposure, the reduction of experiential avoidance, emotion regulation, and the modification of maladaptive patterns. In the final sessions, the acquired skills are reviewed, with an emphasis on consolidating and applying them in daily life and situations relevant to the treatment process.</i_keyword>
      <i_keyword>Control group: Participants in this group will not receive any intervention from the researcher during the study and will simply benefit from the center's standard treatment services. No additional therapeutic or educational sessions will be conducted for this group, and their routine treatment process will continue unchanged.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Experiential avoidance. Timepoint: Before the start of the intervention and after the completion of the 8 intervention sessions. Method of measurement: Gámez et al.'s (2014) Brief Experiential Avoidance Questionnaire.</prim_outcome>
      <prim_outcome>Emotion regulation. Timepoint: Before the start of the intervention and after the completion of the 8 intervention sessions. Method of measurement: Gross and John (2003) Emotion Regulation Questionnaire.</prim_outcome>
      <prim_outcome>Treatment retention. Timepoint: From the start of maintenance treatment until treatment discontinuation by the participant. Method of measurement: The number of days of treatment retention, from initiation to discontinuation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Substance craving. Timepoint: Before the start of the intervention and after the completion of the 8 intervention sessions. Method of measurement: Somoza et al.'s (1995) Substance Craving Questionnaire.</sec_outcome>
      <sec_outcome>Substance cessation self-efficacy. Timepoint: Before the start of the intervention and after the completion of the 8 intervention sessions. Method of measurement: Bramson's Addiction Cessation Self-Efficacy Questionnaire (1999).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before the start of the intervention and after the completion of the 8 intervention sessions. Method of measurement: World Health Organization Quality of Life Questionnaire.</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, Semnan Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-31</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Semnan Branch</contact_name>
        <contact_address>Islamic Azad University, University Town, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
