<?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>IRCT20160808029255N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Integrated Therapy on Couples' Sexual Interactions and Desire</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Integrative Therapy of Emotional-Focused Couple Therapy and Sex Therapy Masters and Johnson on Couples' Interactions and Sexual Desire</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53174</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be conducted by Simple random allocation. After identification of couples who have eligible to enter thee study, each person will select one card among cards which including A or B character. In person select a cord with A character it means she/he will be included to the intervention group and if the card with B character be selected the person will be included to the control group. this process will be continue to all of sample classified in two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Marital Satisfaction. Condition 2: Sexual Knowledge and Attitude. Condition 3: Marital Adjustment. Condition 4: Intimacy. Condition 5: Sexual Disclosure. Condition 6: Female Sexual Function. Condition 7: Male Sexual function. Condition 8: Female Sexual Desire. Condition 9: Male Sexual Desire.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the experimental group, integration of Masters and Johnson Sex Therapy and Emotional Focused Therapy for Couples treatments were held for 10 sessions. Treatment was performed separately for each couple once a week. Standard questionnaires were completed before and after 10 sessions of intervention and also to evaluate the long-term effects of treatment, 8 weeks after the intervention. Intervention 2: Control group: For the control group, Masters and Johnson Sex Therapy treatment was held for 10 sessions. Treatment was performed separately for each couple once a week. Standard questionnaires were completed before and after 10 sessions of intervention and also to evaluate the long-term effects of treatment, 8 weeks after the intervention.</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:
Data of the study would be available after the unrecognizable process of participants.

When:
6 months after publications of findings

To whom:
Data of this research would be available for academic researchers.

Conditions:
Data of this study would be available for same research.

Where to obtain:
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir

How to obtain:
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Raziyeh Maasoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Mirkhani Ave, Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4214</telephone>
        <email>r_masoumi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Raziyeh Maasoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Mirkhani Ave, Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4214</telephone>
        <email>r_masoumi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-55 years old for men
18 years old until premenopausal for women
Having criteria (SIAD) for women and (HSDD) for men according to DSM-V criteria
Moderate and lower sexual desire by the Halbert Questionnaire for men (score 50 and below)
Moderate or less sexual desire or arousal by the Female Sexual Function Index  (score less than 3.4 for sexual arousal or score less than 3.3 for libido, or both)
Interested in attending therapy sessions
At least one year of living together as a permanent marriage
Ability to write and read
Couple age difference less than or equal to 10 years
Duration of marriage between one to 30 years
6 months since the last pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of acute and chronic physical illness
Major psychiatric or psychological illnesses that interfere with treatment
Using drugs that affect sexual function
History of substance abuse or physical aggression
Attending Emotional Focused Therapy for couples or Masters and Johnson sex therapy before studying
History of infertility
Using oral contraception pills
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></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: For the experimental group, integration of Masters and Johnson Sex Therapy and Emotional Focused Therapy for Couples treatments were held for 10 sessions. Treatment was performed separately for each couple once a week. Standard questionnaires were completed before and after 10 sessions of intervention and also to evaluate the long-term effects of treatment, 8 weeks after the intervention.</i_keyword>
      <i_keyword>Control group: For the control group, Masters and Johnson Sex Therapy treatment was held for 10 sessions. Treatment was performed separately for each couple once a week. Standard questionnaires were completed before and after 10 sessions of intervention and also to evaluate the long-term effects of treatment, 8 weeks after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital Satisfaction of Couples. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: ENRICH Marital Satisfaction Scale.</prim_outcome>
      <prim_outcome>Sexual Knowledge and Attitude of Couples. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Sexual Knowledge and Attitude Scale (SKAS).</prim_outcome>
      <prim_outcome>Marital Adjustment of Couples. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Dyadic Adjustment Scale (DAS).</prim_outcome>
      <prim_outcome>Marital Intimacy of Couples. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Marital Intimacy Needs Questionnaire.</prim_outcome>
      <prim_outcome>Spouses Sexual Disclosure. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Spouses Sexual Disclosure Scale.</prim_outcome>
      <prim_outcome>Female Sexual Function. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Male Sexual Function. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: International Index of  Erectile Function (IIEF).</prim_outcome>
      <prim_outcome>Female Sexual Desire. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Male Sexual Desire. Timepoint: Before the intervention, immediately and 8 weeks after the intervention. Method of measurement: Hurlbert Index of Sexual Desire (HISD).</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>2015-05-25</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jerib Street, Azadi Squre Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
