<?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>IRCT20210912052449N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-11</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of cognitive-behavioral group therapy on patients with schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive-behavioral group therapy on improving metacognitive beliefs, insight and adherence of treatment and reducing pressure in caregivers of patients with schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58705</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the intervention group, the treatment program will be performed by an experienced group therapist  in seven sessions with 15 minutes of rest (three times a week) based on a treatment protocol adapted from Robert Paul Lieberman's 16-session community return program. This program is an "Independent and Social Life Skills" program developed by the Center for Psychiatric Rehabilitation Clinical Research at UCLA. Each session begins with an initial discussion and question and then continues for an hour and a half on the topic of the same discussion session. Topics discussed in each session include the following: Session 1: The nature of mental disorders, stigmatization and normalization, Session 2: Communication and expression skills, Session 3: Symptoms of the disorder and symptoms of recurrence, Session 4: Medication, Benefits and side effects, Session 5: Stress management skills, Session 6: Rehabilitation and self-care skills, Session 7: Preparation for discharge. Intervention 2: Intervention group 2: In order to evaluate the effect of the therapist's attention, the therapist's placebo group will watch documentaries without a psychological background for seven sessions in the presence of the therapist and will discuss the subject of the film. Intervention 3: Control group: The control group will also receive only their usual treatments, which include a visit to a psychiatrist.</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:
By identifying individuals, information will only be published in groups

When:
6 months after the end of the research

To whom:
The data will be available only for the Vice Chancellor for Research of Shiraz University of Medical Sciences

Conditions:
Only treatment planning for study participants

Where to obtain:
Principal Investigator

How to obtain:
After the individual application was approved by the Vice Chancellor for Research of Shiraz University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samad Fereidooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Psychiatric Hospital, Bajgah</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7144193355</zip>
        <telephone>+98 71 3260 5678</telephone>
        <email>psysamadf@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samad Fereidooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Psychiatric Hospital, Bajgah</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7144193355</zip>
        <telephone>+98 71 3260 5678</telephone>
        <email>psysamadf@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diagnostic criteria for schizophrenia disorder, according to DSM 5
Age range between 18 and 50 years
Having at least a middle school degree
Not receiving electroconvulsive therapy (at least two months before and during hospitalization)
Not receiving psychological treatments at the same time as entering the study or 3 months before entering the study
Patient and family consent to participate in the study
Living with a family member (at least three months before hospitalization)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are in the acute phase of the disease
Patients who are active substance abusers
Having serious suicidal thoughts
Having any serious medical condition (to prevents further treatment)
Mental retardation
Brain damage
More than one group absence session
Comorbidity of substance dependence disorder
Comorbidity of other psychiatric disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In the intervention group, the treatment program will be performed by an experienced group therapist  in seven sessions with 15 minutes of rest (three times a week) based on a treatment protocol adapted from Robert Paul Lieberman's 16-session community return program. This program is an "Independent and Social Life Skills" program developed by the Center for Psychiatric Rehabilitation Clinical Research at UCLA. Each session begins with an initial discussion and question and then continues for an hour and a half on the topic of the same discussion session. Topics discussed in each session include the following: Session 1: The nature of mental disorders, stigmatization and normalization, Session 2: Communication and expression skills, Session 3: Symptoms of the disorder and symptoms of recurrence, Session 4: Medication, Benefits and side effects, Session 5: Stress management skills, Session 6: Rehabilitation and self-care skills, Session 7: Preparation for discharge.</i_keyword>
      <i_keyword>Intervention group 2: In order to evaluate the effect of the therapist's attention, the therapist's placebo group will watch documentaries without a psychological background for seven sessions in the presence of the therapist and will discuss the subject of the film.</i_keyword>
      <i_keyword>Control group: The control group will also receive only their usual treatments, which include a visit to a psychiatrist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Metacognitive Beliefs Score in Adrienne Wells Metacognitive Beliefs Questionnaire. Timepoint: Assessment of metacognitive beliefs at the beginning of the study (before the intervention) and after the intervention and three months after the intervention. Method of measurement: Adrienne Wells Metacognitive Beliefs Questionnaire.</prim_outcome>
      <prim_outcome>Insight level score based on Insight and Treatment Attitudes Questionnaire. Timepoint: Assessment of the patient's level of insight at the beginning of the study (before the intervention) and after the intervention and three months after the intervention. Method of measurement: Insight and Treatment Attitudes Questionnaire.</prim_outcome>
      <prim_outcome>Score of adherence to treatment on the Medication Adherence Rating Scale. Timepoint: Assessment of patient adherence to treatment at the beginning of the study (before the intervention) and after the intervention and three months after the intervention. Method of measurement: Medication Adherence Rating Scale.</prim_outcome>
      <prim_outcome>Care pressure level score based on Novak care pressure questionnaire. Timepoint: Assessment of the level of care pressure at the beginning of the study (before the intervention) and after the intervention and three months after the intervention. Method of measurement: Novak Care Pressure 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-05</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
