<?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>IRCT20220501054716N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-28</date_registration>
      <primary_sponsor>Ferdowsi University Mashhad</primary_sponsor>
      <public_title>Effect of Compassion-Focused Cognitive-Behavioral Therapy on Self-Criticism, Intolerance of Uncertainty, and Obsessive-Compulsive Housewives</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Compassion-Focused Cognitive-Behavioral Therapy on Self-Criticism, Uncertainty, and Obsessive-Compulsive Housewives</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63306</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: After making the necessary arrangements, among the people who will complete the questionnaires, 30 people will be selected by purposive sampling and then by simple random way so that each of the people numbers 1 and 2, each code number A group is assigned. Then 15 participants will be randomly assigned to the group receiving compassion-based cognitive-behavioral therapy intervention (experimental group) and 15 participants will be assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention group: Participants in the experimental group will receive compassion-focused cognitive-behavioral therapy in 15 sessions of 60 minutes per week. The protocol uses techniques such as soothing breathing rhythm and explaining its goals along with compassionate imagery, the practice of playing a compassionate person, mental imagery, the A-B-C model of obsessive-compulsive disorder, challenging dysfunctional thoughts, and cognitive distortions associated with obsessive-compulsive disorder. Gathering evidence to confirm and refute dysfunctional thoughts and cognitive distortions, cognitive reconstruction strategies of obsessive thoughts, exposure and response prevention, activity program to prevent a recurrence, and compassionate self-correction are used. Various psychological therapies have been developed for individuals with obsessive-compulsive disorder. The results of a study showed that cognitive-behavioral therapy is effective in the psychological symptoms of patients with emotional disorders such as depression and obsessive-compulsive disorder (Huntley, Araya, and Salisbury, 2012). But patients with obsessive-compulsive disorder who have personality problems and self-criticism have had a poor response to this treatment.  In this regard, compassion-based therapy has been recently used to treat these patients (Gilbert, 2010).  Roostaei Alisha and Badiee (2019) showed in a study that self-compassion training is effective on the self-critical self-esteem of middle-aged women (Roostaei Alisha and Badiee, 2019). Alternative rational thoughts in cognitive behavioral-cognitive therapy are analytical and solid. These thoughts were far from inner kindness to some therapists who could not feel the thoughts and images (Gilbert, 2010).  In this regard, Asano, Koike, Shinohara, Kamimori, Nakagawa, Iwo, and Shimizu (2017) studied the effectiveness of compassion-based cognitive-behavioral therapy on depressed individuals.  In their research, first cognitive techniques and then self-compassion techniques were applied (Asano et al., 2017).  However, in the present study, according to previous research (Didrich, Hoffman, Kippers, and Breaking, 2016) and Gilbert's perspective (Gilbert, 2010), due to dealing with cognitive confrontations from a compassionate position, first self-compassion techniques and then cognitive techniques were performed.  In addition, the present study used the cognitive-behavioral therapy protocol (Clark, 2006);  The effectiveness of this protocol has been confirmed in previous studies for patients with obsessive-compulsive disorder (Rakoshik and McManus, 2010)..</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 According to ethical principles, I have no decision to publish at the moment.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sayed Saber Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi Province, Mashhad, Mohammadieh Boulevard, Mohammadieh 8, Rahmanieh 17</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188986445</zip>
        <telephone>+98 51 3524 2373</telephone>
        <email>saber.mousavi09240@gmail.com</email>
        <affiliation>Education of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sayed Saber Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi Province, Mashhad, Mohammadieh Boulevard, Mohammadieh 8, Rahmanieh 17</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188986445</zip>
        <telephone>+98 51 3524 2373</telephone>
        <email>saber.mousavi09240@gmail.com</email>
        <affiliation>Education of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having conscious satisfaction
Housewives
Age range 40-20 years
Suffering from the signs and symptoms of obsessive-compulsive disorder
Failure to receive other therapies at the same time
Getting a score higher than the cut-off point in the questionnaires</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to continue cooperation in research
Do not attend two or more sessions (for the experimental group)
Biased and incomplete answers to the desired questionnaires
Exacerbation of symptoms and referral to a psychiatrist</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the experimental group will receive compassion-focused cognitive-behavioral therapy in 15 sessions of 60 minutes per week. The protocol uses techniques such as soothing breathing rhythm and explaining its goals along with compassionate imagery, the practice of playing a compassionate person, mental imagery, the A-B-C model of obsessive-compulsive disorder, challenging dysfunctional thoughts, and cognitive distortions associated with obsessive-compulsive disorder. Gathering evidence to confirm and refute dysfunctional thoughts and cognitive distortions, cognitive reconstruction strategies of obsessive thoughts, exposure and response prevention, activity program to prevent a recurrence, and compassionate self-correction are used. Various psychological therapies have been developed for individuals with obsessive-compulsive disorder. The results of a study showed that cognitive-behavioral therapy is effective in the psychological symptoms of patients with emotional disorders such as depression and obsessive-compulsive disorder (Huntley, Araya, and Salisbury, 2012). But patients with obsessive-compulsive disorder who have personality problems and self-criticism have had a poor response to this treatment.  In this regard, compassion-based therapy has been recently used to treat these patients (Gilbert, 2010).  Roostaei Alisha and Badiee (2019) showed in a study that self-compassion training is effective on the self-critical self-esteem of middle-aged women (Roostaei Alisha and Badiee, 2019). Alternative rational thoughts in cognitive behavioral-cognitive therapy are analytical and solid. These thoughts were far from inner kindness to some therapists who could not feel the thoughts and images (Gilbert, 2010).  In this regard, Asano, Koike, Shinohara, Kamimori, Nakagawa, Iwo, and Shimizu (2017) studied the effectiveness of compassion-based cognitive-behavioral therapy on depressed individuals.  In their research, first cognitive techniques and then self-compassion techniques were applied (Asano et al., 2017).  However, in the present study, according to previous research (Didrich, Hoffman, Kippers, and Breaking, 2016) and Gilbert's perspective (Gilbert, 2010), due to dealing with cognitive confrontations from a compassionate position, first self-compassion techniques and then cognitive techniques were performed.  In addition, the present study used the cognitive-behavioral therapy protocol (Clark, 2006);  The effectiveness of this protocol has been confirmed in previous studies for patients with obsessive-compulsive disorder (Rakoshik and McManus, 2010).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-critical. Timepoint: Pre-test and post-test. Method of measurement: self-critical scale.</prim_outcome>
      <prim_outcome>Intolerance of indecision. Timepoint: Pre-test and post-test. Method of measurement: intolerance of indecision scale.</prim_outcome>
      <prim_outcome>Symptoms and signs of obsessive-compulsive disorder. Timepoint: Pre-test and post-test. Method of measurement: Moudsley Obsessive Compulsive disorder scale.</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>Ferdowsi University Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-30</approval_date>
        <contact_name>Research Ethics Committees of Ferdowsi University of Mashhad</contact_name>
        <contact_address>Iran, Mashhad, Azadi Square, Ferdowsi University of Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
