xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05988333</url>
    </required_header>
    <id_info>
      <org_study_id>0012764/2023</org_study_id>
      <nct_id>NCT05988333</nct_id>
    </id_info>
    <brief_title>Psychoeducational Intervention for Families With a Member Affected by Major Depression</brief_title>
    <official_title>The Efficacy of Psychoeducational Family Intervention for Major Depression: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Università degli Studi di Brescia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Bologna</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Catanzaro</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Cagliari</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Florence</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli Studi di Ferrara</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Foggia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universita degli Studi di Genova</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Milan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Modena and Reggio Emilia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli Studi del Piemonte Orientale &quot;Amedeo Avogadro&quot;</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Parma</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli Studi di Perugia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Pisa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università Politecnica delle Marche</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Roma La Sapienza</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Rome Tor Vergata</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Catholic University of the Sacred Heart</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli Studi di Sassari</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Siena</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli studi di Trieste</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universita di Verona</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Major depressive disorder (MDD) is the most common mental disorder. It can be a huge burden&#xD;
        not only for the person affected by it, but also for his/her whole family. The goal of this&#xD;
        clinical trial is to test the efficacy of a family supportive intervention called&#xD;
        psychoeducational family intervention (PFI) compared to a brief informative intervention in&#xD;
        families with a member affected by MDD. Families will participate in one of the two&#xD;
        interventions for a period of 6 months more or less, and they will be asked to answer some&#xD;
        questionnaires about how much MDD impacts on their everyday life and the patient's symptoms,&#xD;
        in order to understand whether a more structured intervention such as PFI can be useful for&#xD;
        families in order to better deal with this complicated illness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present paper is a no-profit, not-funded, national, multicentric, randomized-controlled&#xD;
        trial with blinded outcome assessments, carried out in 24 Italian University outpatient units&#xD;
        and coordinated by the Department of Mental and Physical Health and Preventive Medicine of&#xD;
        the University of Campania Luigi Vanvitelli. In each center, 8 patients (and their families)&#xD;
        and 8 controls will be recruited, for a total of 192 families assigned to the experimental&#xD;
        group and 192 to the control group (total sample size = 384 families). Families are assessed&#xD;
        at the baseline and 6-, 12- and 24-months post-randomization.&#xD;
  &#xD;
        The primary aim of this study is to assess the efficacy of PFI in a group of patients with a&#xD;
        diagnosis of MDD in terms of: 1) reduction of depressive symptoms; 2) improvement of&#xD;
        psychosocial functioning; 3) improvement of social network. Furthermore, the efficacy of PFI&#xD;
        will be also evaluated in terms of: 1) reduction of relapses and hospitalization in the 18&#xD;
        months following the end of the intervention; 2) improvement of adherence to pharmacological&#xD;
        treatments and of patients' quality of life; 3) reduction of self-stigma; 4) improvement of&#xD;
        coping strategies, family burden, and expressed emotion of family members of patients with&#xD;
        major depression; 5) improvement of quality of life of family members. Finally, our study&#xD;
        will investigate whether the presence of specific temperamental profiles and childhood&#xD;
        traumas may mediate the effectiveness of the psychoeducational intervention.&#xD;
  &#xD;
        The experimental intervention consists of the psychoeducational family intervention developed&#xD;
        by Ian Falloon for the treatment of schizophrenia, which has been adapted to major depression&#xD;
        and to the Italian context. The experimental intervention will be administered individually&#xD;
        to each recruited family and consists of six phases: 1) engagement of the family unit; 2)&#xD;
        individual assessment; 3) family assessment; 4) informative sessions; 5) communication skills&#xD;
        sessions; 6) problem-solving skills sessions.&#xD;
  &#xD;
        Patients and their relatives will be provided with information on: 1) the clinical&#xD;
        characteristics of MDD, including onset and course, symptoms, prognosis, risk and protective&#xD;
        factors; 2) available pharmacological and non-pharmacological treatments of MDD, its&#xD;
        indications, side effects and strategies to cope with them, treatment duration, risk factors&#xD;
        for relapse, and effects related to abrupt cessation of the therapy; 3) early signs of&#xD;
        crisis, with the identification of the user's specific signs, completion and use of an ad-hoc&#xD;
        form, the usefulness of their recognition for the prevention of episodes. A specific&#xD;
        informative session on suicide has been developed, which will be administered only if the&#xD;
        patients had a previous suicide attempt or report suicidal ideation during the intervention.&#xD;
  &#xD;
        Each meeting is ideally divided into three phases: a first phase dedicated to clarifications&#xD;
        and questions regarding the topics previously discussed; a second phase focused on the main&#xD;
        topic of the meeting (the so-called &quot;teaching phase&quot;); and a final phase, in which the&#xD;
        salient aspects discussed during the meeting are summarized, and &quot;homework&quot; is assigned.&#xD;
  &#xD;
        The control group will receive an informative intervention consisting of five sessions,&#xD;
        administered every 7-10 days, with the following content: healthy lifestyle habits (diet and&#xD;
        nutrition), stress management, regulation of circadian rhythms, and management of&#xD;
        medications' side effects.&#xD;
  &#xD;
        The interventions will be discontinued if: 1) patients or their relatives will be unable to&#xD;
        attend more than five consecutive psychoeducational sessions; 2) patients will be&#xD;
        hospitalized or had any affective relapse during the intervention; or 3) patients or&#xD;
        relatives withdraw their consent.&#xD;
  &#xD;
        In both groups, patients will continue to receive the treatment usually provided in their&#xD;
        center.&#xD;
  &#xD;
        Trainings for the conduction of the intervention and for the use of assessment tools will be&#xD;
        provided by the coordinating center. Two researchers (at least one being a psychiatrist) for&#xD;
        each center will participate in a four-day training. During the training, a manual to conduct&#xD;
        the experimental intervention is provided to participants, and several role-plays are&#xD;
        organized. At least one researcher per center, not involved in the administration of the&#xD;
        interventions, will be trained in the use of assessment tools and inter-rater reliability&#xD;
        measurement. The training will include the following phases: a) presentation of the&#xD;
        assessment instruments; b) group reading; c) simulations of administration; d) video-recorded&#xD;
        interviews.&#xD;
  &#xD;
        Work hypotheses is that the PFI will be effective in reducing severity of depressive&#xD;
        symptoms, relapses and hospitalizations, and an improvement in adherence to pharmacological&#xD;
        treatments, quality of life a reduction in internalized stigma, and an improvement in coping&#xD;
        strategies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of depressive symptoms</measure>
      <time_frame>At baseline, after 6-, 12- and 24 months</time_frame>
      <description>Hamilton Depression Rating Scale (HAM-D). The HAM-D includes 17 items. Of these, 8 items are scored from 0 (absent) to 4 (severe), while nine are scored from 0 to 2. The total score is performed by the sum of the items' scores, and ranges from 0 to 52 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Psychosocial functioning</measure>
      <time_frame>At baseline, after 6-, 12- and 24 months</time_frame>
      <description>Personal and Social Performance Scale (PSP). A total score can be attributed to score the overall patient's functioning, ranging from 0 to 100, with higher scores indicating higher functioning. Ratings are based mainly on the assessment of patient's functioning in four main areas: (1) socially useful activities; (2) personal and social relationships; (3) self-care; and (4) disturbing and aggressive behaviors.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity of anxiety symptoms</measure>
      <time_frame>At baseline, after 6-, 12- and 24 months</time_frame>
      <description>Hamilton Anxiety Rating Scale (HAM-A). It is a 14-items questionnaire developed to measure the severity of anxiety symptoms, both psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety). The score for each item ranges from 0 (not present) to 4 (extreme severity).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Social contacts</measure>
      <time_frame>At baseline, after 6-, 12- and 24 months</time_frame>
      <description>Columbia Suicide Severity Rating Scale (C-SSRS). The clinician-administered version of the C-SSRS (screening version) will be administered. Individual's suicidal ideation is rated on a scale from 1 (wish to be dead) to 5 (active suicidal ideation with a specific plan and intent).&#xD;
  Social Network Questionnaire (SNQ).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">384</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Psychoeducational Family Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental intervention will be administered individually to each recruited family. Sessions will take place three times a month for a period ranging from 4 to 6 months (about 18 sessions in total). The number of sessions, as well as the frequency, may vary depending on the patient's clinical situation. Sessions will have an average duration of 60-90 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Informative intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The informative intervention consists of five sessions, administered every 7-10 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Psychoeducational Family Intervention</intervention_name>
      <description>Supportive intervention administered to families with a member affected by MDD</description>
      <arm_group_label>Psychoeducational Family Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Informative intervention</intervention_name>
      <description>Informative intervention administered to families with a member affected by MDD</description>
      <arm_group_label>Informative intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of major depression, according to Diagnostic and Statistical Manual of&#xD;
               Mental Disorders, Fifth Edition;&#xD;
  &#xD;
            -  ability to provide informed consent;&#xD;
  &#xD;
            -  presence of at least one contact per month with the psychiatric clinic for at least&#xD;
               six months prior to recruitment;&#xD;
  &#xD;
            -  cohabitation with at least one family member.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  moderate or severe cognitive deficits, physical illnesses preventing the participation&#xD;
               to the sessions or if they were hospitalization in the two months prior the enrollment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mario Luciano, Doctor</last_name>
      <phone>+393490730150</phone>
      <email>mario.luciano@unicampania.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Campania L. Vanvitelli</name>
        <address>
          <city>Napoli</city>
          <zip>80138</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Luciano, Doctor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
      <investigator_full_name>Mario Luciano</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>family psychoeducation, major depression, caregiver</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05988333
  org study id: 0012764/2023
  nct id: NCT05988333
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  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Major depressive disorder (MDD) is the most common mental disorder. It can be a huge burden
        not only for the person affected by it, but also for his/her whole family. The goal of this
        clinical trial is to test the efficacy of a family supportive intervention called
        psychoeducational family intervention (PFI) compared to a brief informative intervention in
        families with a member affected by MDD. Families will participate in one of the two
        interventions for a period of 6 months more or less, and they will be asked to answer some
        questionnaires about how much MDD impacts on their everyday life and the patient's symptoms,
        in order to understand whether a more structured intervention such as PFI can be useful for
        families in order to better deal with this complicated illness.
  The present paper is a no-profit, not-funded, national, multicentric, randomized-controlled
        trial with blinded outcome assessments, carried out in 24 Italian University outpatient units
        and coordinated by the Department of Mental and Physical Health and Preventive Medicine of
        the University of Campania Luigi Vanvitelli. In each center, 8 patients (and their families)
        and 8 controls will be recruited, for a total of 192 families assigned to the experimental
        group and 192 to the control group (total sample size = 384 families). Families are assessed
        at the baseline and 6-, 12- and 24-months post-randomization.
  
        The primary aim of this study is to assess the efficacy of PFI in a group of patients with a
        diagnosis of MDD in terms of: 1) reduction of depressive symptoms; 2) improvement of
        psychosocial functioning; 3) improvement of social network. Furthermore, the efficacy of PFI
        will be also evaluated in terms of: 1) reduction of relapses and hospitalization in the 18
        months following the end of the intervention; 2) improvement of adherence to pharmacological
        treatments and of patients' quality of life; 3) reduction of self-stigma; 4) improvement of
        coping strategies, family burden, and expressed emotion of family members of patients with
        major depression; 5) improvement of quality of life of family members. Finally, our study
        will investigate whether the presence of specific temperamental profiles and childhood
        traumas may mediate the effectiveness of the psychoeducational intervention.
  
        The experimental intervention consists of the psychoeducational family intervention developed
        by Ian Falloon for the treatment of schizophrenia, which has been adapted to major depression
        and to the Italian context. The experimental intervention will be administered individually
        to each recruited family and consists of six phases: 1) engagement of the family unit; 2)
        individual assessment; 3) family assessment; 4) informative sessions; 5) communication skills
        sessions; 6) problem-solving skills sessions.
  
        Patients and their relatives will be provided with information on: 1) the clinical
        characteristics of MDD, including onset and course, symptoms, prognosis, risk and protective
        factors; 2) available pharmacological and non-pharmacological treatments of MDD, its
        indications, side effects and strategies to cope with them, treatment duration, risk factors
        for relapse, and effects related to abrupt cessation of the therapy; 3) early signs of
        crisis, with the identification of the user's specific signs, completion and use of an ad-hoc
        form, the usefulness of their recognition for the prevention of episodes. A specific
        informative session on suicide has been developed, which will be administered only if the
        patients had a previous suicide attempt or report suicidal ideation during the intervention.
  
        Each meeting is ideally divided into three phases: a first phase dedicated to clarifications
        and questions regarding the topics previously discussed; a second phase focused on the main
        topic of the meeting (the so-called "teaching phase"); and a final phase, in which the
        salient aspects discussed during the meeting are summarized, and "homework" is assigned.
  
        The control group will receive an informative intervention consisting of five sessions,
        administered every 7-10 days, with the following content: healthy lifestyle habits (diet and
        nutrition), stress management, regulation of circadian rhythms, and management of
        medications' side effects.
  
        The interventions will be discontinued if: 1) patients or their relatives will be unable to
        attend more than five consecutive psychoeducational sessions; 2) patients will be
        hospitalized or had any affective relapse during the intervention; or 3) patients or
        relatives withdraw their consent.
  
        In both groups, patients will continue to receive the treatment usually provided in their
        center.
  
        Trainings for the conduction of the intervention and for the use of assessment tools will be
        provided by the coordinating center. Two researchers (at least one being a psychiatrist) for
        each center will participate in a four-day training. During the training, a manual to conduct
        the experimental intervention is provided to participants, and several role-plays are
        organized. At least one researcher per center, not involved in the administration of the
        interventions, will be trained in the use of assessment tools and inter-rater reliability
        measurement. The training will include the following phases: a) presentation of the
        assessment instruments; b) group reading; c) simulations of administration; d) video-recorded
        interviews.
  
        Work hypotheses is that the PFI will be effective in reducing severity of depressive
        symptoms, relapses and hospitalizations, and an improvement in adherence to pharmacological
        treatments, quality of life a reduction in internalized stigma, and an improvement in coping
        strategies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Severity of depressive symptoms
  time frame: At baseline, after 6-, 12- and 24 months
  description: Hamilton Depression Rating Scale (HAM-D). The HAM-D includes 17 items. Of these, 8 items are scored from 0 (absent) to 4 (severe), while nine are scored from 0 to 2. The total score is performed by the sum of the items' scores, and ranges from 0 to 52 points.
  measure: Psychosocial functioning
  time frame: At baseline, after 6-, 12- and 24 months
  description: Personal and Social Performance Scale (PSP). A total score can be attributed to score the overall patient's functioning, ranging from 0 to 100, with higher scores indicating higher functioning. Ratings are based mainly on the assessment of patient's functioning in four main areas: (1) socially useful activities; (2) personal and social relationships; (3) self-care; and (4) disturbing and aggressive behaviors.
  measure: Severity of anxiety symptoms
  time frame: At baseline, after 6-, 12- and 24 months
  description: Hamilton Anxiety Rating Scale (HAM-A). It is a 14-items questionnaire developed to measure the severity of anxiety symptoms, both psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety). The score for each item ranges from 0 (not present) to 4 (extreme severity).
  measure: Social contacts
  time frame: At baseline, after 6-, 12- and 24 months
  description: Columbia Suicide Severity Rating Scale (C-SSRS). The clinician-administered version of the C-SSRS (screening version) will be administered. Individual's suicidal ideation is rated on a scale from 1 (wish to be dead) to 5 (active suicidal ideation with a specific plan and intent).
  Social Network Questionnaire (SNQ).
  arm group label: Psychoeducational Family Intervention
  arm group type: Experimental
  description: The experimental intervention will be administered individually to each recruited family. Sessions will take place three times a month for a period ranging from 4 to 6 months (about 18 sessions in total). The number of sessions, as well as the frequency, may vary depending on the patient's clinical situation. Sessions will have an average duration of 60-90 minutes.
  arm group label: Informative intervention
  arm group type: Active Comparator
  description: The informative intervention consists of five sessions, administered every 7-10 days.
  intervention type: Other
  intervention name: Psychoeducational Family Intervention
  description: Supportive intervention administered to families with a member affected by MDD
  arm group label: Psychoeducational Family Intervention
  intervention type: Other
  intervention name: Informative intervention
  description: Informative intervention administered to families with a member affected by MDD
  arm group label: Informative intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Mario Luciano, Doctor
  phone: +393490730150
  email: mario.luciano@unicampania.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Campania "Luigi Vanvitelli"
  investigator full name: Mario Luciano
  investigator title: Doctor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: No