<?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>IRCT20260915071060N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-03</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Acceptance and Commitment Therapy and Compassion-Focused Therapy on Relapse Risk and Craving in Amphetamine/Methamphetamine Users</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Acceptance and Commitment Therapy and Compassion-Focused Therapy on Relapse Risk and Craving in Amphetamine/Methamphetamine Users</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/93365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the article text (sud.docx), the randomization process was conducted using the specialized "Random Allocation Software."

The details are as follows:

Implementation method: Following the initial selection of participants and the verification of inclusion criteria, the researchers used the aforementioned software to assign participants to different groups.
Grouping: Participants were randomly divided into three main groups:
Intervention Group 1: Acceptance and Commitment Therapy (ACT)
Intervention Group 2: Compassion-Focused Therapy (CFT)
Control Group
The use of this software in clinical trials is a standard and valid method employed to minimize bias in participant selection and group allocation, thereby enhancing the study's internal validity, Blinding description: Package coding: Medications are dispensed by an independent pharmacist or a random coding system with coded labels so that the doctor and patient can code A or B without knowing the nature of the medication.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Amphetamine use disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Act psychotherapy treatment. Intervention 2: Intervention group: Intervention name (title): Acceptance and Commitment Therapy (ACT) with the Matrix Basic Model. Intervention description: In addition to receiving 8 weekly sessions of the Matrix Model (relapse prevention education, healthy lifestyle, and self-help programs), patients in this group underwent 8 weekly sessions of individual Acceptance and Commitment Therapy (ACT) for 45 minutes per session.  The sessions were conducted by a psychiatrist who was proficient in the intervention, and the patients were followed up twice, two weeks apart. Intervention group: First session: Clinical interview, case conceptualization, and training on how the mind works. Second session: Examining ineffective strategies of mental restraint and control using the "tug-of-war" exercise and metaphor. Third session: Creating creative hopelessness through the "farm of life" metaphor. Fourth session: Psychoeducation of the inner and outer world, distinguishing between pure and impure suffering, using the "sensitive device" metaphor, and the "1-2-3" experimental exercise. Fifth session: Promoting psychological acceptance and willingness with the "uninvited guest" metaphor and identifying cognitive errors with the "bus" metaphor. Sixth session: Self-as-Context exercise and mindfulness of the conceptualized self using the "chessboard" and "billboard" metaphors. Intervention 3: Intervention group: Intervention group 2 (Compassion-Focused Therapy - CFT) (Create a new box by clicking the Add button and entering the following text) Intervention name (title): Compassion-Focused Therapy (CFT) with the basic matrix model Intervention description: In addition to 8 weekly sessions of the matrix model, patients in this group underwent 8 weekly sessions of individual compassion-focused psychotherapy (CFT) for 45 minutes per session by the same psychiatrist, and follow-up was conducted twice with two-week intervals. Title and content of CFT sessions: Intervention group: First session: Conclusion of a therapeutic contract, diagnostic compassion interview, providing feedback, and the first step of formulation and conceptualization. Second session: Second step of conceptualization based on the cultural context and history of the client, creating empathy and feedback based on compassion. Third session: Third step of conceptualization, functional analysis of different areas of life and identification of the pathological vicious cycle and unkindness to oneself. Fourth session: Training in the ancient/modern/conscious brain model and the triple model of motivation  And the emotion of compassion to enhance the client's motivation to move towards compassion. Session Five: Explaining the effect of kindness and compassion in stopping the cycle of blaming and unkindness to oneself and the mind. Session Six: Conceptualizing and activating the "Compassionate Self", teaching its characteristics and comparing it with other vulnerable parts of the self. Session Seven: Assessing the alignment of the compassionate self with life values, reviewing caring for individual well-being with the "One Great Day" exercise, identifying internal/external barriers, and teaching compassion-based behaviors. Session Eight: Revisiting the conceptualization matrix, reviewing the disease cycle and ways to prevent the return of symptoms, teaching life practice, and assessing readiness and periodic follow-up. Intervention 4: Control group: Control group: Participants in this group received only the standard and basic substance withdrawal program (including 8 weekly sessions of the Matrix model aimed at teaching temptation and relapse prevention, healthy lifestyle, and participation in self-help programs) and no specific additional individual psychotherapy intervention (either ACT or CFT) was implemented for them. The initial assessment and follow-up of this group were conducted simultaneously with the two intervention groups (immediately after the course and follow-ups at two-week intervals) using the Relapse Prediction Questionnaire (RPS).</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:
There is a plan for the publication of approved items.

When:
One year

To whom:
Medical students and professors

Conditions:
The best way to increase knowledge and awareness is through registration in a reputable scientific journal.

Where to obtain:
Registration in a reputable journal

How to obtain:
By searching other similar articles

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Elham mohebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3633 0642</telephone>
        <email>dr.eli.mohebati.1983@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Elham mohebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3633 0642</telephone>
        <email>dr.eli.mohebati.1983@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range: 18 to 50 years.
 Place of residence: Resident of Isfahan
Education: Minimum of a high school diploma.
 Diagnosis: Confirmed diagnosis of amphetamine abuse or dependence (without abuse of other substances or alcohol).
Treatment history: No pharmacological or psychological intervention for substance abuse in the past six months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence from sessions: Missing three or more treatment sessions (intervention protocol).
 Relapse: Experiencing any relapse or return to amphetamine use during the intervention period.
 Non-cooperation: Expression of unwillingness to participate or discontinuation of cooperation by the participant during the course of treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F15.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other stimulant dependence</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Act psychotherapy treatment</i_keyword>
      <i_keyword>Intervention group: Intervention name (title): Acceptance and Commitment Therapy (ACT) with the Matrix Basic Model. Intervention description: In addition to receiving 8 weekly sessions of the Matrix Model (relapse prevention education, healthy lifestyle, and self-help programs), patients in this group underwent 8 weekly sessions of individual Acceptance and Commitment Therapy (ACT) for 45 minutes per session.  The sessions were conducted by a psychiatrist who was proficient in the intervention, and the patients were followed up twice, two weeks apart. Intervention group: First session: Clinical interview, case conceptualization, and training on how the mind works. Second session: Examining ineffective strategies of mental restraint and control using the "tug-of-war" exercise and metaphor. Third session: Creating creative hopelessness through the "farm of life" metaphor. Fourth session: Psychoeducation of the inner and outer world, distinguishing between pure and impure suffering, using the "sensitive device" metaphor, and the "1-2-3" experimental exercise. Fifth session: Promoting psychological acceptance and willingness with the "uninvited guest" metaphor and identifying cognitive errors with the "bus" metaphor. Sixth session: Self-as-Context exercise and mindfulness of the conceptualized self using the "chessboard" and "billboard" metaphors.</i_keyword>
      <i_keyword>Intervention group: Intervention group 2 (Compassion-Focused Therapy - CFT) (Create a new box by clicking the Add button and entering the following text) Intervention name (title): Compassion-Focused Therapy (CFT) with the basic matrix model Intervention description: In addition to 8 weekly sessions of the matrix model, patients in this group underwent 8 weekly sessions of individual compassion-focused psychotherapy (CFT) for 45 minutes per session by the same psychiatrist, and follow-up was conducted twice with two-week intervals. Title and content of CFT sessions: Intervention group: First session: Conclusion of a therapeutic contract, diagnostic compassion interview, providing feedback, and the first step of formulation and conceptualization. Second session: Second step of conceptualization based on the cultural context and history of the client, creating empathy and feedback based on compassion. Third session: Third step of conceptualization, functional analysis of different areas of life and identification of the pathological vicious cycle and unkindness to oneself. Fourth session: Training in the ancient/modern/conscious brain model and the triple model of motivation  And the emotion of compassion to enhance the client's motivation to move towards compassion. Session Five: Explaining the effect of kindness and compassion in stopping the cycle of blaming and unkindness to oneself and the mind. Session Six: Conceptualizing and activating the "Compassionate Self", teaching its characteristics and comparing it with other vulnerable parts of the self. Session Seven: Assessing the alignment of the compassionate self with life values, reviewing caring for individual well-being with the "One Great Day" exercise, identifying internal/external barriers, and teaching compassion-based behaviors. Session Eight: Revisiting the conceptualization matrix, reviewing the disease cycle and ways to prevent the return of symptoms, teaching life practice, and assessing readiness and periodic follow-up.</i_keyword>
      <i_keyword>Control group: Control group: Participants in this group received only the standard and basic substance withdrawal program (including 8 weekly sessions of the Matrix model aimed at teaching temptation and relapse prevention, healthy lifestyle, and participation in self-help programs) and no specific additional individual psychotherapy intervention (either ACT or CFT) was implemented for them. The initial assessment and follow-up of this group were conducted simultaneously with the two intervention groups (immediately after the course and follow-ups at two-week intervals) using the Relapse Prediction Questionnaire (RPS).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparing the effectiveness of CFT with ACT. Timepoint: Two months. Method of measurement: 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-08</approval_date>
        <contact_name>This study was designed in accordance with the principles of the Declaration of Helsin</contact_name>
        <contact_address>Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
