<?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>IRCT20230910059391N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-01</date_registration>
      <primary_sponsor>Neyshabour University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on grief, psychological distress, symptoms related to sleep disturbances, coping strategies and quality of life in caregivers of cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on grief, psychological distress, symptoms related to sleep disturbances, coping strategies and quality of life in caregivers of cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72993</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of implementation in this research will be as follows: First, permission will be obtained through the Maxa Cancer Control Charitable Foundation located in Mashhad, and then in order to help refer and introduce the participants (families of cancer patients), from This foundation will make the necessary arrangements. In the following, 45 people will be selected from the mentioned statistical population using the available sampling method and will be assigned to three groups of 15 people in the test and the control group using random replacement. Next, necessary information will be given on how to implement the protocol and efforts will be made to establish a good relationship with mutual cooperation. After the pre-test, separate test groups will participate in cognitive-behavioral therapy and emotion-oriented therapy sessions, and then the post-test and 2-month follow-up will be performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: grief. Condition 2: psychological distress. Condition 3: symptoms related to sleep disturbances. Condition 4: coping strategies. Condition 5: quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1 on which cognitive behavioral therapy is implemented. Intervention 2: Intervention group: Intervention group 2, on which emotion-oriented therapy is implemented. Intervention 3: Control group: The number of people in the control group is 15 who do not receive any 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on
grief, psychological distress, symptoms related to sleep disturbances, coping strategies and 
quality of life in caregivers of cancer patients

When:
Starting from February 1402 and with a period of 6 months

To whom:
Academic sciences

Conditions:
The general public

Where to obtain:
09151079787

How to obtain:
Message or email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezoo Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 16، South Kausar 12، South Kausar Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177915594</zip>
        <telephone>+98 51 3882 9543</telephone>
        <email>arezoo.habibi051@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 16، South Kausar 12، South Kausar Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177915594</zip>
        <telephone>+98 51 3882 9543</telephone>
        <email>arezoo.habibi051@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Having at least a diploma
Having a caregiver role for a person with cancer (usually as a family member or close friend)
Caring for patients who have been diagnosed with cancer for at least one year
The cancer must be of an advanced type as diagnosed by the doctor
Informed consent to receive medical services
Regular participation in therapy sessions (cognitive behavioral therapy and emotion-oriented therapy) according to protocol therapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe cognitive and personality disorders and taking psychiatric drugs
Drug abuse
Simultaneous participation in other psychological interventions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.8</hc_code>
      <hc_code>F68.0</hc_code>
      <hc_code>G47.2</hc_code>
      <hc_code>F43.9</hc_code>
      <hc_code>Z62.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other reactions to severe stress</hc_keyword>
      <hc_keyword>Elaboration of physical symptoms for psychological reasons</hc_keyword>
      <hc_keyword>Disorders of the sleep-wake schedule  / Delayed sleep phase syndrome  / Irregular sleep-wake pattern</hc_keyword>
      <hc_keyword>Reaction to severe stress, unspecified</hc_keyword>
      <hc_keyword>Other specified problems related to upbringing</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1 on which cognitive behavioral therapy is implemented</i_keyword>
      <i_keyword>Intervention group: Intervention group 2, on which emotion-oriented therapy is implemented</i_keyword>
      <i_keyword>Control group: The number of people in the control group is 15 who do not receive any treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bereavement score in the Caregiver Anticipatory Assessment Scale. Timepoint: Bereavement measurement is done at the beginning of the study and before the start of therapeutic interventions and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and the measurement is done in the follow-up sessions with an interval of two months after the end of the treatment. will be. Method of measurement: Caregiver Anticipatory Grief Assessment Scale.</prim_outcome>
      <prim_outcome>The score of coping strategies in the Jalovis coping scale questionnaire. Timepoint: Coping strategies are carried out at the beginning of the study and before the start of therapeutic interventions and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and the measurement is done in the follow-up sessions with an interval of two months after the end of the treatment. will be. Method of measurement: Jallowis coping questionnaire.</prim_outcome>
      <prim_outcome>Quality of life score in the quality of life questionnaire. Timepoint: The quality of life is measured at the beginning of the study and before the start of treatment interventions and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and the measurement is done in the follow-up sessions with an interval of two months after the end of the treatment. to be. Method of measurement: Quality of life questionnaire.</prim_outcome>
      <prim_outcome>The score of psychological disturbances in Wechsler's standard psychological distress questionnaire form 10 questions. Timepoint: Psychological disturbances. Method of measurement: Wechsler psychological distress scale.</prim_outcome>
      <prim_outcome>The score of symptoms related to sleep disturbances in the Pittsburgh Sleep Questionnaire. Timepoint: Symptoms related to sleep disturbances are measured at the beginning of the study and before the start of therapeutic interventions, and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and measurements are taken in follow-up sessions with an interval of two months after The treatment is completed. Method of measurement: Petersburg Sleep 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>Neyshabour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-14</approval_date>
        <contact_name>National system of ethics in biomedical research</contact_name>
        <contact_address>Khorasan Razavi Province, Neishabur, Research Blvd., Islamic Azad University Complex, Neishabur branch neyshabour Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
