<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/NCT04442776</url>
  </required_header>
  <id_info>
    <org_study_id>Study DAIP</org_study_id>
    <secondary_id>ESTUDIO PAI-D</secondary_id>
    <nct_id>NCT04442776</nct_id>
  </id_info>
  <brief_title>Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis</brief_title>
  <acronym>PAI-D</acronym>
  <official_title>Validation of a Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis Admitted to a Psychiatric Hospitalization Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardenal Herrera University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardenal Herrera University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: validate a Dual Integrated Attention Program (D-AIP) for mental health nursing in people&#xD;
      with Severe Dual Diagnosis admitted to a psychiatric hospitalization unit&#xD;
&#xD;
      Design: Randomized Controlled Trial. Population: Inpatients with dual diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of the project is to validate a Dual Integrated Attention Program (D-AIP)&#xD;
      for mental health nursing in people with Severe Dual Diagnosis admitted to a psychiatric&#xD;
      hospitalization unit, assessing change motivation, insight, medication adherence, drug&#xD;
      consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety, which&#xD;
      this context generates. For this purpose, a randomized, prospective, one-year-longitudinal&#xD;
      clinical trial will be conducted. This study will be applied on patients with diagnosis of&#xD;
      schizophrenia, schizoaffective disorder and bipolar disorder types I and II who, after&#xD;
      accepting to participate in the study and signing the informed consent, answer the PRISM&#xD;
      questionnaire of admission in the hospitalization unit and fulfill the dual pathology&#xD;
      criteria. After, they will be randomized in control group and intervention group (only the&#xD;
      later will complete the D-AIP).&#xD;
&#xD;
      The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and&#xD;
      during follow-up up to one year after discharge in which 4 individual sessions and 3&#xD;
      telephone contacts will be made. In both groups, a different person from the one who performs&#xD;
      the intervention and without knowledge of the group belonging will assess them with&#xD;
      questionnaires in 9 moments during the whole follow-up year (Socrates 8D, Scale of&#xD;
      Unawareness of Mental Disorder &quot;SUMD&quot;, Morisky Medication Adherence Scale &quot;MMAS-8&quot;, Working&#xD;
      Alliance Inventory &quot;WAI&quot;, Hamilton Anxiety Rating Scale &quot;HARS&quot; y Hopelessness Scale &quot;HS&quot;) and&#xD;
      will collect a urine sample in each evaluation. The sample size will be 86 subjects, for&#xD;
      α=0.05 and power=0.80.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2021</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>
    <intervention_model_description>Randomized Controlled Trial (Parallel Assignment)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stages of Change Readiness</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by Questionnaire SOCRATES 8D</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insight</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by Scale Unawareness of Mental Disorders (SUMD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by Medication Adherence Scale (MMAS-8)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Therapeutic Alliance</measure>
    <time_frame>2-3 months</time_frame>
    <description>Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by Hamilton Anxiety Rating Scale (HARS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hopelessness</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by Hopelessness Scale (HS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Containments methods</measure>
    <time_frame>2-3 months</time_frame>
    <description>Number of registered containments methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use change</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of drug abuse through a urine sample with &quot;10-panel drug test&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmissions</measure>
    <time_frame>12 months</time_frame>
    <description>Number of registered hospital readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual diagnosis knowledge</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by ad-hoc questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Diagnosis, Dual (Psychiatry)</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will complete the Dual Integrated Attention Program (D-AIP) The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and during follow-up up to one year after discharge in which 4 individual sessions and 3 telephone contacts will be made.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will complete the usual treatment. One session per day voluntary during admission and discharge, nursing consultations only to put injectable medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>D-AIP</intervention_name>
    <description>Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inpatients diagnosed with some serious mental illness of the following:&#xD;
&#xD;
               -  Inpatients with diagnosis of schizophrenia&#xD;
&#xD;
               -  Inpatients with diagnosis schizoaffective disorder&#xD;
&#xD;
               -  Inpatients with diagnosis bipolar disorder types I&#xD;
&#xD;
               -  Inpatients with diagnosis bipolar disorder types II&#xD;
&#xD;
          2. Consumption of addictive substances&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intellectually Disabled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Montse Cañabate, Dra.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardenal Herrera University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Montse Cañabate, Dra.</last_name>
    <phone>+34-601-209-435</phone>
    <email>montserrat.canabate@uchceu.es</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardenal Herrera University</investigator_affiliation>
    <investigator_full_name>Montse Cañabate</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Psychiatric Dual Diagnosis</keyword>
  <keyword>Integrated Attention</keyword>
  <keyword>Program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04442776
org study id: Study DAIP
secondary id: ESTUDIO PAI-D
nct id: NCT04442776
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim: validate a Dual Integrated Attention Program (D-AIP) for mental health nursing in people
      with Severe Dual Diagnosis admitted to a psychiatric hospitalization unit

      Design: Randomized Controlled Trial. Population: Inpatients with dual diagnosis.
The main objective of the project is to validate a Dual Integrated Attention Program (D-AIP)
      for mental health nursing in people with Severe Dual Diagnosis admitted to a psychiatric
      hospitalization unit, assessing change motivation, insight, medication adherence, drug
      consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety, which
      this context generates. For this purpose, a randomized, prospective, one-year-longitudinal
      clinical trial will be conducted. This study will be applied on patients with diagnosis of
      schizophrenia, schizoaffective disorder and bipolar disorder types I and II who, after
      accepting to participate in the study and signing the informed consent, answer the PRISM
      questionnaire of admission in the hospitalization unit and fulfill the dual pathology
      criteria. After, they will be randomized in control group and intervention group (only the
      later will complete the D-AIP).

      The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and
      during follow-up up to one year after discharge in which 4 individual sessions and 3
      telephone contacts will be made. In both groups, a different person from the one who performs
      the intervention and without knowledge of the group belonging will assess them with
      questionnaires in 9 moments during the whole follow-up year (Socrates 8D, Scale of
      Unawareness of Mental Disorder "SUMD", Morisky Medication Adherence Scale "MMAS-8", Working
      Alliance Inventory "WAI", Hamilton Anxiety Rating Scale "HARS" y Hopelessness Scale "HS") and
      will collect a urine sample in each evaluation. The sample size will be 86 subjects, for
      α=0.05 and power=0.80.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial (Parallel Assignment)
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Stages of Change Readiness
time frame: 12 months
description: Assessed by Questionnaire SOCRATES 8D
measure: Insight
time frame: 12 months
description: Assessed by Scale Unawareness of Mental Disorders (SUMD)
measure: Medication Adherence
time frame: 12 months
description: Assessed by Medication Adherence Scale (MMAS-8)
measure: Therapeutic Alliance
time frame: 2-3 months
description: Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)
measure: Anxiety
time frame: 12 months
description: Assessed by Hamilton Anxiety Rating Scale (HARS)
measure: Hopelessness
time frame: 12 months
description: Assessed by Hopelessness Scale (HS)
measure: Containments methods
time frame: 2-3 months
description: Number of registered containments methods
measure: Drug use change
time frame: 12 months
description: Presence of drug abuse through a urine sample with "10-panel drug test"
measure: Hospital readmissions
time frame: 12 months
description: Number of registered hospital readmissions
measure: Dual diagnosis knowledge
time frame: 12 months
description: Assessed by ad-hoc questionnaire
arm group label: Intervention group
arm group type: Experimental
description: The intervention group will complete the Dual Integrated Attention Program (D-AIP) The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and during follow-up up to one year after discharge in which 4 individual sessions and 3 telephone contacts will be made.
arm group label: Control group
arm group type: No Intervention
description: The control group will complete the usual treatment. One session per day voluntary during admission and discharge, nursing consultations only to put injectable medication
intervention type: Behavioral
intervention name: D-AIP
description: Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Montse Cañabate, Dra.
role: Principal Investigator
affiliation: Cardenal Herrera University
last name: Montse Cañabate, Dra.
phone: +34-601-209-435
email: montserrat.canabate@uchceu.es
responsible party type: Principal Investigator
investigator affiliation: Cardenal Herrera University
investigator full name: Montse Cañabate
investigator title: Principal Investigator
mesh term: Disease