<?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>IRCT20201119049440N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-04</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effectiveness of group training in hope therapy approach on quality of life and meaning of life</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of group training of hope therapy approach on quality of life and meaning of life of patients with MS and their family caregivers in Rafideh Rehabilitation Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52475</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, inclusion and exclusion criteria in patients with MS and their caregivers were evaluated. Then, meaning of life and quality of life questionnaires were distributed. Then 30 patients and 30 caregivers
Average or low scores were obtained in these two questionnaires. The names of these 30 patients were written on paper. The name paper was separated and placed in a basket. Then we took a piece of paper each time and put it in the test basket or control basket. This process continued for 30 patients until 15 patients were included in the experimental basket and 15 patients in the control group. The researcher used the lottery method when selecting the names, and therefore there was no bias or intentionality in assigning individuals to the two groups. Exactly the same procedure was performed for 30 patient caregivers. In fact, the randomization was simple and by lottery. Due to the low number of samples, this was done manually.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Meaning of life and quality of life.</hc_freetext>
      <i_freetext>Intervention 1: experimental group 1: or group of patients with MS: For this group, a group training protocol of hope therapy was provided. This treatment protocol is designed for eight two-hour sessions that are performed for the group of MS patients and their family members with the necessary adjustments and adaptations. For example, patient assignments and family member assignments are different. Also, each session consists of 4 sections. In the first section, which lasts approximately 83 minutes, group members discuss the topics of the per session, review the assignment of the previous session, and encourage members to help each other solve homework problems. In the second section, which lasts approximately 83 minutes, group members are taught a new hope-related skill that includes three dimensions: goals, directions, and agent thinking. Apply these skills in their lives, discuss and encourage them to articulate their problems and help each other learn how to use these skills to solve their problems. During this part of group therapy, the therapist leads the group to discuss the skill as the main topic of the group. Finally, in the final ten minutes of the group, members are given a homework assignment for the next session, with the goal of having the members of the group apply hope-related skills in their daily lives. At the beginning of the group, as a general task, members are asked to choose a specific goal to work in group meetings to apply the skills learned on that specific goal in each session Control group 1: A group of MS patients remained in a non-intervention state and after the intervention and post-test and to observe ethics. They received several training sessions. Intervention 2: Intervention group 2: or experimental group 2 (group of caregivers of patient with MS): For this group, a group training protocol of hope therapy was provided. This treatment protocol is designed for eight two-hour sessions that are performed for the group of MS patients and their family members with the necessary adjustments and adaptations. For example, patient assignments and family member assignments are different. Also, each session consists of 4 sections. In the first section, which lasts approximately 83 minutes, group members discuss the topics of the per-session, review the assignment of the previous session, and encourage members to help each other solve homework problems. In the second section, which lasts approximately 83 minutes, group members are taught a new hope-related skill that includes three dimensions: goals, directions, and agent thinking. Apply these skills in their lives, discuss and encourage them to articulate their problems and help each other learn how to use these skills to solve their problems. During this part of group therapy, the therapist leads the group to discuss the skill as the main topic of the group. Finally, in the final ten minutes of the group, members are given a homework assignment for the next session, with the goal of having the members of the group apply hope-related skills in their daily lives. At the beginning of the group, as a general task, members are asked to choose a specific goal to work in group meetings to apply the skills learned on that specific goal in each session.         Control group 2: The caregiver of patients with MS remained in a non-intervention state and after the intervention and post-test and to observe ethics. They received several training sessions.</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:
Documentation is provided in the article

When:
Documentation is provided in the article

To whom:
By publishing an article, everyone in this field can use the article

Conditions:
Documentation is provided in the article

Where to obtain:
Documentation is provided in the article

How to obtain:
Documentation is provided in the article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moslem Arian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Evin, Daneshjoo Blvd., Koodkiar dead end</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>mo.arian@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moslem Arian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Evin, Daneshjoo Blvd., Koodkiar dead end</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>mo.arian@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for admission of the patient: with MS
Informed consent
Get a low or average score in the meaning of life and quality of life questionnaire
Criteria for patient exit: dissatisfaction and withdrawal
Achieve high scores in the questionnaires of meaning of life and quality of life
Criteria for caregiver entry: Family member of a patient with MS and being the primary caregiver
Informed consent
Get a medium or low score in the Meaning and Quality of Life Questionnaire
Criteria for leaving the caregiver: dissatisfaction or withdrawal from continuing the research
Get a high score in the Meaning and Quality of Life Questionnaire</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Get a high score on the Quality of Life Questionnaire
Get a high score on the meaning of life questionnaire
Receive parallel psychological treatment or interventions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>experimental group 1: or group of patients with MS: For this group, a group training protocol of hope therapy was provided. This treatment protocol is designed for eight two-hour sessions that are performed for the group of MS patients and their family members with the necessary adjustments and adaptations. For example, patient assignments and family member assignments are different. Also, each session consists of 4 sections. In the first section, which lasts approximately 83 minutes, group members discuss the topics of the per session, review the assignment of the previous session, and encourage members to help each other solve homework problems. In the second section, which lasts approximately 83 minutes, group members are taught a new hope-related skill that includes three dimensions: goals, directions, and agent thinking. Apply these skills in their lives, discuss and encourage them to articulate their problems and help each other learn how to use these skills to solve their problems. During this part of group therapy, the therapist leads the group to discuss the skill as the main topic of the group. Finally, in the final ten minutes of the group, members are given a homework assignment for the next session, with the goal of having the members of the group apply hope-related skills in their daily lives. At the beginning of the group, as a general task, members are asked to choose a specific goal to work in group meetings to apply the skills learned on that specific goal in each session Control group 1: A group of MS patients remained in a non-intervention state and after the intervention and post-test and to observe ethics. They received several training sessions.</i_keyword>
      <i_keyword>Intervention group 2: or experimental group 2 (group of caregivers of patient with MS): For this group, a group training protocol of hope therapy was provided. This treatment protocol is designed for eight two-hour sessions that are performed for the group of MS patients and their family members with the necessary adjustments and adaptations. For example, patient assignments and family member assignments are different. Also, each session consists of 4 sections. In the first section, which lasts approximately 83 minutes, group members discuss the topics of the per-session, review the assignment of the previous session, and encourage members to help each other solve homework problems. In the second section, which lasts approximately 83 minutes, group members are taught a new hope-related skill that includes three dimensions: goals, directions, and agent thinking. Apply these skills in their lives, discuss and encourage them to articulate their problems and help each other learn how to use these skills to solve their problems. During this part of group therapy, the therapist leads the group to discuss the skill as the main topic of the group. Finally, in the final ten minutes of the group, members are given a homework assignment for the next session, with the goal of having the members of the group apply hope-related skills in their daily lives. At the beginning of the group, as a general task, members are asked to choose a specific goal to work in group meetings to apply the skills learned on that specific goal in each session.         Control group 2: The caregiver of patients with MS remained in a non-intervention state and after the intervention and post-test and to observe ethics. They received several training sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Meaning of life: This variable, which is designed by the meaning of life questionnaire of Steger et al., Has two subscales: meaning presence and meaning search. This variable was evaluated before and after the implementation of the protocol to measure the changes resulting from the implementation of the protocol in the two intervention groups. Timepoint: A pre-test is taken before the protocol is implemented and after the protocol is implemented (which takes one month). So the test is taken. That is, this variable is measured twice. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Quality of life: This variable has been evaluated with the MSIS-29 Quality of Life Questionnaire, which includes two subscales of physical and mental quality of life. This variable was evaluated before and after the implementation of the protocol to measure the changes resulting from the implementation of the protocol in the two intervention groups. Timepoint: A pre-test is taken before the protocol is implemented and after the protocol is implemented (which takes one month). So the test is taken. That is, this variable is measured twice. Method of measurement: 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-28</approval_date>
        <contact_name>University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Tehran, Evin, Daneshjoo Blvd., Koodkiar dead end Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
