<?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>IRCT20250129064559N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-02</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Modeling the vulnerability to extramarital relationships and the effectiveness of couple therapy based on the acceptance and commitment therapy with schema awareness on couples with extramarital relationships experience and relational obsessive-compulsive symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Modeling the vulnerability to extramarital relationships and the effectiveness of couple therapy based on the acceptance and commitment therapy with schema awareness on couples with extramarital relationships experience and relational obsessive-compulsive symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81918</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization will be used for randomization purposes. Eligible participants will be assigned to either the experimental group (n=16) or the control group (n=16) using block randomization. The block size will be set to 4, and the selection of each block will also be done randomly. (It is explained that, considering the sample size of the study (32 couples), the number of blocks is estimated to be 8 blocks. Each block is numbered and used for 4 couples, the order of which will be different in the blocks. Each block will include an equal number of couples from each treatment group. In total, the possible arrangement is as follows: BBAA, ABAB, BABA, ABBA, BAAB, AABB. Each of these combinations is assigned a number from 1 to 6. Then, 8 blocks of four are randomly selected. For this purpose, a random number between 1 and 6 is selected 8 times. Neither the research participants nor the researchers will be aware of which treatment group each couple will be assigned to until the randomization process is complete. This will prevent selection bias.), Blinding description: This study will implement a double-blind design to minimize bias and ensure the validity of results. In a double-blind study, both the participants and the outcome assessors will be blinded to the group allocation throughout the study. This means: The couples participating in the study will not be informed about whether they have been assigned to the experimental group or the control group. The randomization process, as detailed, will ensure that group assignment is kept confidential until the study is completed. The individual responsible for assessing the outcomes will also remain blinded to the group assignment. They will conduct the assessments without knowledge of whether the participant belongs to the experimental or control group. This ensures that the outcome measures are unbiased and unaffected by any preconceptions about the treatment condition. In addition, the data analysis and statistical evaluation of the results will be conducted without access to the group’s information, preventing any unconscious bias in the interpretation of the data. By maintaining this double-blind approach, the study will minimize potential biases in treatment administration, outcome assessment, and data interpretation, ensuring that the findings accurately reflect the effects of the treatment intervention rather than pre-existing expectations or assumptions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>extramarital relationships.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:   Contents of the intervention sessions for Acceptance and Commitment Couple Therapy with schema awareness (Experimental Group):1. Establishing rapport, explaining the importance of participation and homework completion, agreeing on scheduling and rules, providing an overview of the treatment, and administering the pre-test. 2. Psychoeducation on and identification of communication schemas, discussion of their development and manifestation in marital life. 3. Identifying coping behaviors, educating about the impact of schemas, addressing coping behaviors and the negative role of avoidance. 4. Exploring coping behaviors, addressing out-of-session results of coping behaviors, introducing metaphors. 5. Clarifying values, identifying values related to the communication domain. 6. Identifying cognitive barriers to value-based responses and identifying moments of choice, psychoeducation on barriers. 7. Addressing cognitive barriers to value-based responses, teaching cognitive defusion and practicing cognitive defusion strategies. 8. Mindfulness training, teaching loving-kindness breathing and mindful affect, emotional confrontation of the schema to cultivate mindfulness of schema-related pain. 9. Communication skills training, teaching about expressing needs, effective communication, pausing with a time interval, and appreciation. 10. Teaching values-based and flexible problem-solving skills for couples. 11. Teaching the best choice for achieving values, using reverse role-playing to create empathy. 12. Reviewing and summarizing treatment sessions, addressing participants' questions, and administering the post-test. Intervention 2: Control group:   Contents of the intervention sessions for Acceptance and Commitment Couple Therapy (Control Group):1.Assessment, strengthening the therapeutic relationship, and determining treatment direction. Gathering details, introducing treatment goals, and explaining the focus on practice. 2. Individual assessments, couple formulation, integrating individual and couple assessments. 3. Examining the costs of couples' conflict and avoidance, creating creative hopelessness, using metaphors and practice. 4. Mindfulness and acceptance. 5. Cognitive fusion, explaining the negative relationship of thoughts for couples, practice. 6. Creating an observer perspective and comparing one's own and self's reactions in relation to the spouse. Practice. 7. Helping to clarify and identify values and doing exercises. 8. Reviewing values worksheets, discussing barriers to life values. 9. Creating flexible behavioral patterns in relationships. 10. The nature of choice and the ability to respond, using metaphors. 11. Reviewing emotional willingness in the context of committed action. 12. Reviewing relationship values and committed action, preparing for future committed action, and terminating treatment.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No additional information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyede Ayda Mousavi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th Floor, Unit 7, No. 49, Heshmat Alley, Beginning of Tabatabaei Nasab Boulevard, Farjam Street, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1685965418</zip>
        <telephone>+98 21 6692 6608</telephone>
        <email>mousavi.ay@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Ayda Mousavi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th Floor, Unit 7, No. 49, Heshmat Alley, Beginning of Tabatabaei Nasab Boulevard, Farjam Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1685965418</zip>
        <telephone>+98 21 6692 6608</telephone>
        <email>mousavi.ay@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Couples must be legally married and have been in a committed relationship for at least one year.
Both partners must have a minimum of a high school diploma (or equivalent).
Both partners must be between the ages of 20 and 60 years old.
Couples must not have a history of alcohol, drug, or psychotropic substance abuse or dependence.
Both partners must be willing to participate in couple therapy sessions and be able to attend sessions consistently and regularly.
Couples must be living together at the time of enrollment and throughout the study, and must not be in the process of legal divorce.
Couples should not be experiencing significant stressors such as unemployment or remarriage (for either partner).
Couples must have experienced at least one instance of sexual or emotional infidelity in their current marital relationship and express a desire to increase marital satisfaction and address the negative consequences of the infidelity experience (e.g., anxiety, depression, marital dissatisfaction).
At least 6 months and no more than 5 years must have passed since the disclosure of the extramarital affair within their relationship.
Based on the results of the SCID-5/RV interview (and the Relationship-Focused and Partner-Focused Obsessive-Compulsive Questionnaires), couples must report relationship-related or partner-focused obsessive-compulsive beliefs, but not meet the full diagnostic criteria for Obsessive-Compulsive Disorder.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- Presence of a psychological disorder in either partner
- Use of any type of psychiatric medication
- Use of any psychological or psychotherapeutic services for Axis I and II disorders and marital problems within the 6 months prior to the start of treatment
- Presence of serious suicidal ideation
- Absence from more than 3 treatment sessions
- Initiation of drug or substance use during the intervention
- Diagnosis of an acute psychiatric or physical illness during the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z63.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems in relationship with spouse or partner</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:   Contents of the intervention sessions for Acceptance and Commitment Couple Therapy with schema awareness (Experimental Group):1. Establishing rapport, explaining the importance of participation and homework completion, agreeing on scheduling and rules, providing an overview of the treatment, and administering the pre-test. 2. Psychoeducation on and identification of communication schemas, discussion of their development and manifestation in marital life. 3. Identifying coping behaviors, educating about the impact of schemas, addressing coping behaviors and the negative role of avoidance. 4. Exploring coping behaviors, addressing out-of-session results of coping behaviors, introducing metaphors. 5. Clarifying values, identifying values related to the communication domain. 6. Identifying cognitive barriers to value-based responses and identifying moments of choice, psychoeducation on barriers. 7. Addressing cognitive barriers to value-based responses, teaching cognitive defusion and practicing cognitive defusion strategies. 8. Mindfulness training, teaching loving-kindness breathing and mindful affect, emotional confrontation of the schema to cultivate mindfulness of schema-related pain. 9. Communication skills training, teaching about expressing needs, effective communication, pausing with a time interval, and appreciation. 10. Teaching values-based and flexible problem-solving skills for couples. 11. Teaching the best choice for achieving values, using reverse role-playing to create empathy. 12. Reviewing and summarizing treatment sessions, addressing participants' questions, and administering the post-test.</i_keyword>
      <i_keyword>Control group:   Contents of the intervention sessions for Acceptance and Commitment Couple Therapy (Control Group):1.Assessment, strengthening the therapeutic relationship, and determining treatment direction. Gathering details, introducing treatment goals, and explaining the focus on practice. 2. Individual assessments, couple formulation, integrating individual and couple assessments. 3. Examining the costs of couples' conflict and avoidance, creating creative hopelessness, using metaphors and practice. 4. Mindfulness and acceptance. 5. Cognitive fusion, explaining the negative relationship of thoughts for couples, practice. 6. Creating an observer perspective and comparing one's own and self's reactions in relation to the spouse. Practice. 7. Helping to clarify and identify values and doing exercises. 8. Reviewing values worksheets, discussing barriers to life values. 9. Creating flexible behavioral patterns in relationships. 10. The nature of choice and the ability to respond, using metaphors. 11. Reviewing emotional willingness in the context of committed action. 12. Reviewing relationship values and committed action, preparing for future committed action, and terminating treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score on the Beck Anxiety Inventory. Timepoint: Before the intervention, after the intervention, and 3 months after the intervention is completed. Method of measurement: Beck anxiety inventory.</prim_outcome>
      <prim_outcome>Depression score on the Beck Depression Inventory. Timepoint: Before the intervention, after the intervention, and 3 months after the intervention is completed. Method of measurement: Beck depression inventory.</prim_outcome>
      <prim_outcome>Marital adjustment score on the Dyadic Adjustment Scale (DAS). Timepoint: Before the intervention, after the intervention, and 3 months after the intervention is completed. Method of measurement: Dyadic Adjustment Scale (DAS).</prim_outcome>
      <prim_outcome>Psychological Inflexibility. Timepoint: Before the intervention, after the intervention, and 3 months after the intervention is completed. Method of measurement: The Multidimensional Psychological Flexibility Inventory (MPFI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Conflict resolution styles score on Rahim Organizational Conflict Inventory–II (ROCI-II). Timepoint: Before the intervention, after the intervention, and 3 months after the intervention is completed. Method of measurement: Rahim Organizational Conflict Inventory–II(ROCI-II).</sec_outcome>
      <sec_outcome>Relational Obsessive-Compulsive Disorder score on the The Relationship Obsessive–Compulsive Inventory and the The Partner-Related Obsessive–Compulsive Symptoms Inventory. Timepoint: Before the intervention, after the intervention, and 3 months after the intervention is completed. Method of measurement: The Relationship Obsessive–Compulsive Inventory (ROCI) and The Partner-Related Obsessive–Compulsive Symptoms Inventory (PROCSI).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-29</approval_date>
        <contact_name>Ethics committee of Iran Medical Sciences University</contact_name>
        <contact_address>Iran Medical Sciences University, shahid Hemat highway,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
