<?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>IRCT20200122046228N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-27</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of counseling with a motivational interviewing approach on marital quality and satisfaction in couples with poor marital relationship quality referring to comprehensive health centers in Sari city</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of couple counseling with a motivational interviewing approach on marital quality and satisfaction in women referring to comprehensive health centers in Sari city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82164</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this parallel randomized controlled trial study, given that not all individuals enter the study at the same time and that the researchers cannot predict in advance which group each patient entering the study will belong to, the block randomization method will be used to assign each sample to one of the two groups. In order to conceal the random assignment, the codes generated by the software will be placed in opaque envelopes so that it is not clear which group the next person will be placed in. In this study, eligible participants will be allocated to one of the two control and intervention groups in a 1:1 ratio and in blocks of six, according to the block randomization protocol (generated by Random Allocation Software), in such a way that the researcher cannot predict which intervention group the next person will be placed in. The codes will be placed in the opaque envelopes, and with each new person entering the study, the envelope will be opened and the person's belonging to the relevant group will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Marital quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, participants will receive couple counseling using a motivational interviewing approach, in addition to the routine care provided for individuals of reproductive age. Educational sessions will be conducted over six consecutive weeks, each lasting 60 minutes. Specifically, the first, third, and fifth sessions will be held in person, while the remaining sessions will consist of 60 minutes of online counseling conducted weekly via video conferencing on platforms such as WhatsApp and Eitaa.To ensure that participants engage with the material, follow-up calls will be made two days after the content is shared. This will provide the researcher with the opportunity to offer individual counseling to each participant.In-person sessions will also occur individually for 60 minutes in designated rooms at the sampling centers, adhering to guidelines that ensure a conducive counseling environment, including appropriate physical conditions, minimal client traffic, and reduced noise levels.It is important to note that prior to the commencement of this work, the midwifery counseling student will be trained in the motivational interviewing approach under the supervision of a psychology counselor. Following proficiency in this approach and subsequent approval from relevant faculty members, the sampling process will initiate under their guidance. Additionally, weekly telephone supervision will be implemented throughout the duration of the trial.The content of the couple counseling sessions will include principles of couple counseling, stages of change in marital lifestyles and behaviors, ambivalences related to marital adjustment, effective verbal and nonverbal communication strategies to enhance marital quality of life, advantages and disadvantages of changes in marital lifestyles and behaviors, reconstruction techniques, values and goals for improving marital lifestyles and behaviors, temptations to revert to pre-change behaviors, and strategies for preventing relapse. Intervention 2: Control group: The control group will receive routine care for women of reproductive age. Routine care for women in this demographic at a health center typically includes a range of health services and screenings designed to support reproductive health and overall well-being. The main components of this care include:Health Assessments: Comprehensive evaluations that include medical history, physical examinations, and vital sign measurements.Screening Tests: This includes Pap smears for the detection of cervical cancer and precancerous conditions. Mammograms are performed for breast cancer screening, typically for women aged 40 and older.Family Planning Services: Provision of necessary counseling on family planning options.Support and Management for Chronic Conditions: Assistance for women with chronic illnesses that may impact reproductive health, such as diabetes and hypertension.Lifestyle Counseling: Guidance for clients on maintaining a healthy lifestyle, including physical activity, dietary habits, and stress management.Referral Services: Referral to specialists as needed for any identified issues or conditions.</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 Its release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Nasiri-Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical School, Ganjafrooze street</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-47176</zip>
        <telephone>+98 11 3219 0597</telephone>
        <email>nasiri_fa@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Nasiri- Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 0597</telephone>
        <email>nasiri_fa@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being married
Having lived together for at least one year and a maximum of 20 years
Having a stable sexual relationship
Not having a spouse with sexual disorders or chronic diseases according to the individual's own statements
Not having acute conflict to the extent of being on the verge of divorce
Not taking hormone replacement therapy in women and testosterone in men.
Not participating in any educational-counseling classes before or during the study
Obtaining a score of less than 2.84 on the marital quality of life questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The occurrence of unfortunate life events such as the death of relatives and incurable diseases in family members in the last month
Death of spouse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F68.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified disorders of adult personality and behavior</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, participants will receive couple counseling using a motivational interviewing approach, in addition to the routine care provided for individuals of reproductive age. Educational sessions will be conducted over six consecutive weeks, each lasting 60 minutes. Specifically, the first, third, and fifth sessions will be held in person, while the remaining sessions will consist of 60 minutes of online counseling conducted weekly via video conferencing on platforms such as WhatsApp and Eitaa.To ensure that participants engage with the material, follow-up calls will be made two days after the content is shared. This will provide the researcher with the opportunity to offer individual counseling to each participant.In-person sessions will also occur individually for 60 minutes in designated rooms at the sampling centers, adhering to guidelines that ensure a conducive counseling environment, including appropriate physical conditions, minimal client traffic, and reduced noise levels.It is important to note that prior to the commencement of this work, the midwifery counseling student will be trained in the motivational interviewing approach under the supervision of a psychology counselor. Following proficiency in this approach and subsequent approval from relevant faculty members, the sampling process will initiate under their guidance. Additionally, weekly telephone supervision will be implemented throughout the duration of the trial.The content of the couple counseling sessions will include principles of couple counseling, stages of change in marital lifestyles and behaviors, ambivalences related to marital adjustment, effective verbal and nonverbal communication strategies to enhance marital quality of life, advantages and disadvantages of changes in marital lifestyles and behaviors, reconstruction techniques, values and goals for improving marital lifestyles and behaviors, temptations to revert to pre-change behaviors, and strategies for preventing relapse.</i_keyword>
      <i_keyword>Control group: The control group will receive routine care for women of reproductive age. Routine care for women in this demographic at a health center typically includes a range of health services and screenings designed to support reproductive health and overall well-being. The main components of this care include:Health Assessments: Comprehensive evaluations that include medical history, physical examinations, and vital sign measurements.Screening Tests: This includes Pap smears for the detection of cervical cancer and precancerous conditions. Mammograms are performed for breast cancer screening, typically for women aged 40 and older.Family Planning Services: Provision of necessary counseling on family planning options.Support and Management for Chronic Conditions: Assistance for women with chronic illnesses that may impact reproductive health, such as diabetes and hypertension.Lifestyle Counseling: Guidance for clients on maintaining a healthy lifestyle, including physical activity, dietary habits, and stress management.Referral Services: Referral to specialists as needed for any identified issues or conditions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital quality. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Revised Dyadic Adjustment Scales (RDAS) of Sexual Quality of Couples.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Marital satisfaction. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Enrich Marital Satisfaction 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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-11</approval_date>
        <contact_name>Health Research Institute Babol University of Medcal Sciences</contact_name>
        <contact_address>Ganj Afrooz St., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
