<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/NCT03275909</url>
  </required_header>
  <id_info>
    <org_study_id>PSI2011-27590</org_study_id>
    <nct_id>NCT03275909</nct_id>
  </id_info>
  <brief_title>Integrated Psychological Therapy for Chronic Schizophrenia</brief_title>
  <official_title>Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Basque Country (UPV/EHU)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Economía y Competitividad, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of the Basque Country (UPV/EHU)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: The chronic phase of schizophrenia (CS) that extremely affects the way people&#xD;
      think, feel and act, underlines the need for effective interventions in patients affected by&#xD;
      this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines&#xD;
      as the reference therapy in the treatment of this type of patients. In this paper authors&#xD;
      propose to include in this program a new module focused on Emotional Management Therapy in&#xD;
      order to reinforce its effectiveness. The aim of this study is to describe the design of a&#xD;
      study protocol for a randomized controlled trial in which the objective is to assess the&#xD;
      efficacy of this modified IPT program in patients with CS compared to treatment as usual&#xD;
      (pharmacological treatment and social and leisure activities in a Day Care Center).&#xD;
&#xD;
      Methods/design: This is a randomized study with pre and post-treatment assessment and with a&#xD;
      6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1)&#xD;
      a experimental group: integrated psychological therapy in conjunction with emotional&#xD;
      management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in&#xD;
      addition to the treatment as usual (TAU), or (2) a control group (treatment as usual).&#xD;
      Participants in both groups will be evaluated at baseline (pre-treatment) and at&#xD;
      post-treatment after 8 months. The primary outcome will be that patients in the experimental&#xD;
      group will show a greater improvement over participants in the control group in reducing&#xD;
      symptoms and increasing emotional abilities, as well as in improving their quality of life.&#xD;
      The secondary outcome will be that these results will maintain at the 6- and 12-month&#xD;
      follow-up in the experimental group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The chronic phase of schizophrenia (CS) that extremely affects the way people&#xD;
      think, feel and act, underlines the need for effective interventions in patients affected by&#xD;
      this disorder. The Integrated Psychological Therapy (IPT) appears in clinical practice&#xD;
      guidelines as the reference therapy in the treatment of this type of patients. In this paper&#xD;
      authors propose to include in this program a new module focused on Emotional Management&#xD;
      Therapy (EMT) in order to reinforce its effectiveness. The aim of this study is to describe&#xD;
      the design of a study protocol for a randomized controlled trial in which the objective is to&#xD;
      assess the efficacy of this modified IPT program in patients with CS compared to treatment as&#xD;
      usual (pharmacological treatment and social and leisure activities in a Day Care Center).&#xD;
&#xD;
      Methods/design: This is a randomized study with pre and post-treatment assessment and with a&#xD;
      6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1)&#xD;
      a experimental group: integrated psychological therapy in conjunction with emotional&#xD;
      management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in&#xD;
      addition to the treatment as usual (TAU), or (2) a control group (treatment as usual).&#xD;
      Participants in both groups will be evaluated at baseline (pre-treatment) and at&#xD;
      post-treatment after 8 months. The primary outcome will be that patients in the experimental&#xD;
      group will show a greater improvement over participants in the control group in reducing&#xD;
      symptoms and increasing emotional abilities, as well as in improving their quality of life.&#xD;
      The secondary outcome will be that these results will maintain at the 6- and 12-month&#xD;
      follow-up in the experimental group.&#xD;
&#xD;
      Discussion: This study provides the description of a clinical trial based on specific&#xD;
      psychological intervention (IPT+EMT) for patients with chronic schizophrenia, aiming to&#xD;
      improve lasting clinical and functional outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2011</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">July 30, 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frankfurt Complaint Questionnaire (FBF-3)</measure>
    <time_frame>Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up</time_frame>
    <description>(Assessing change)This is a self-report test composed of 98 items measuring the presence of the &quot;basic&quot; symptoms of schizophrenia. These are subjectively experienced disturbances at different domains including perception, thought, processing, language and attention that it could be the neurobiological features of schizophrenia. It contains 10 subscales and 4 factors. We will use a validated version for the Spanish population, in which Cronbach's alpha was above .95 and the test-retest reliability was above .60</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screen for Cognitive Impairment in Psychiatry (SCIP)</measure>
    <time_frame>Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up</time_frame>
    <description>(Assessing change)This test assesses cognitive impairment through five areas: immediate and delayed verbal learning, working memory, verbal fluency and information processing speed. It is used for identifying cognitive impairment. The test-retest reliability ranged from 74 to 90 and Cronbach's alpha was 73.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)</measure>
    <time_frame>Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up</time_frame>
    <description>(Assessing change)Short forms of this scale have been designed for patients with schizophrenia . It assess cognitive functioning. Scores on these short forms are correlated (0.91) with the overall intelligence quotient (IQ) of the full scale in clinical patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wisconsin Card Sorting Test (WCST)</measure>
    <time_frame>Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up</time_frame>
    <description>(Assessing change)This test assesses attention span, planning and execution, and hence is considered a valid measure of executive function. We used the version of the test standardised and benchmarked for the Spanish population by TEA Editions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Functioning Scale (SFS)</measure>
    <time_frame>Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up</time_frame>
    <description>(Assessing change)We will use the short version of the scale, validated in a Spanish clinical sample, with a Cronbach's alpha of 0.76.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lancashire Quality of Life Profile (LQoLP)</measure>
    <time_frame>Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up</time_frame>
    <description>(Assessing change)This instrument assesses patient satisfaction with various aspects of their life, work, leisure time, religion, finances, living situation, safety, family relations, social relations, and health, as well as global wellbeing and self-esteem.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Chronic Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Study procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An experimental group the psychological treatment includes 50 sessions of integrated psychological therapy (IPT) (focused on attentional skills training, social perception skills training, verbal communication skills, social skills training, interpersonal problems solving skills) and 10 sessions of specific emotional management therapy (EMT), designed for this research and based on the contents developed by Hodel, Kern and Brenner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The treatment as usual is pharmacological treatment and activities in a Day Care Center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated Psychological Therapy</intervention_name>
    <description>The psychological treatment includes 50 sessions of integrated psychological therapy focused on attentional skills, social perception skills, verbal communication skills, social skills and interpersonal problems solving skills and 10 sessions of specific emotional management therapy , designed for this research. and based on the contents developed by Hodel, Kern and Brenner</description>
    <arm_group_label>Study procedure</arm_group_label>
    <other_name>Emotional Management Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having ≥ 5 years since disease onset and aged between 25 and 65 years.&#xD;
&#xD;
          2. Being in a stable phase of the illness and under psychopharmacological treatment.&#xD;
&#xD;
          3. Having negative or attenuated positive symptoms.&#xD;
&#xD;
          4. Failing to achieve premorbid functioning in terms of education, work and/or social&#xD;
             life.&#xD;
&#xD;
          5. Agreeing to participate in the study and giving written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Presenting organic brain pathology. 2. Presenting intellectual developmental&#xD;
             disorder according to DSM-5 criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karmele Salaberria, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer of School of Psychology</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of the Basque Country (UPV/EHU)</investigator_affiliation>
    <investigator_full_name>Karmele Salaberria Irizar</investigator_full_name>
    <investigator_title>Phd.-Lecturer</investigator_title>
  </responsible_party>
  <keyword>Chronic schizophrenia</keyword>
  <keyword>Emotional Management Therapy</keyword>
  <keyword>Integrated Psychological Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>to share the study protocol and the clinical study report</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>2011/2017</ipd_time_frame>
    <ipd_access_criteria>Researchers</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 30, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03275909/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 30, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03275909/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 30, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03275909/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03275909
org study id: PSI2011-27590
nct id: NCT03275909
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people
      think, feel and act, underlines the need for effective interventions in patients affected by
      this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines
      as the reference therapy in the treatment of this type of patients. In this paper authors
      propose to include in this program a new module focused on Emotional Management Therapy in
      order to reinforce its effectiveness. The aim of this study is to describe the design of a
      study protocol for a randomized controlled trial in which the objective is to assess the
      efficacy of this modified IPT program in patients with CS compared to treatment as usual
      (pharmacological treatment and social and leisure activities in a Day Care Center).

      Methods/design: This is a randomized study with pre and post-treatment assessment and with a
      6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1)
      a experimental group: integrated psychological therapy in conjunction with emotional
      management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in
      addition to the treatment as usual (TAU), or (2) a control group (treatment as usual).
      Participants in both groups will be evaluated at baseline (pre-treatment) and at
      post-treatment after 8 months. The primary outcome will be that patients in the experimental
      group will show a greater improvement over participants in the control group in reducing
      symptoms and increasing emotional abilities, as well as in improving their quality of life.
      The secondary outcome will be that these results will maintain at the 6- and 12-month
      follow-up in the experimental group.
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people
      think, feel and act, underlines the need for effective interventions in patients affected by
      this disorder. The Integrated Psychological Therapy (IPT) appears in clinical practice
      guidelines as the reference therapy in the treatment of this type of patients. In this paper
      authors propose to include in this program a new module focused on Emotional Management
      Therapy (EMT) in order to reinforce its effectiveness. The aim of this study is to describe
      the design of a study protocol for a randomized controlled trial in which the objective is to
      assess the efficacy of this modified IPT program in patients with CS compared to treatment as
      usual (pharmacological treatment and social and leisure activities in a Day Care Center).

      Methods/design: This is a randomized study with pre and post-treatment assessment and with a
      6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1)
      a experimental group: integrated psychological therapy in conjunction with emotional
      management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in
      addition to the treatment as usual (TAU), or (2) a control group (treatment as usual).
      Participants in both groups will be evaluated at baseline (pre-treatment) and at
      post-treatment after 8 months. The primary outcome will be that patients in the experimental
      group will show a greater improvement over participants in the control group in reducing
      symptoms and increasing emotional abilities, as well as in improving their quality of life.
      The secondary outcome will be that these results will maintain at the 6- and 12-month
      follow-up in the experimental group.

      Discussion: This study provides the description of a clinical trial based on specific
      psychological intervention (IPT+EMT) for patients with chronic schizophrenia, aiming to
      improve lasting clinical and functional outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frankfurt Complaint Questionnaire (FBF-3)
time frame: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up
description: (Assessing change)This is a self-report test composed of 98 items measuring the presence of the "basic" symptoms of schizophrenia. These are subjectively experienced disturbances at different domains including perception, thought, processing, language and attention that it could be the neurobiological features of schizophrenia. It contains 10 subscales and 4 factors. We will use a validated version for the Spanish population, in which Cronbach's alpha was above .95 and the test-retest reliability was above .60
measure: Screen for Cognitive Impairment in Psychiatry (SCIP)
time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
description: (Assessing change)This test assesses cognitive impairment through five areas: immediate and delayed verbal learning, working memory, verbal fluency and information processing speed. It is used for identifying cognitive impairment. The test-retest reliability ranged from 74 to 90 and Cronbach's alpha was 73.
measure: Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
description: (Assessing change)Short forms of this scale have been designed for patients with schizophrenia . It assess cognitive functioning. Scores on these short forms are correlated (0.91) with the overall intelligence quotient (IQ) of the full scale in clinical patients.
measure: Wisconsin Card Sorting Test (WCST)
time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
description: (Assessing change)This test assesses attention span, planning and execution, and hence is considered a valid measure of executive function. We used the version of the test standardised and benchmarked for the Spanish population by TEA Editions.
measure: Social Functioning Scale (SFS)
time frame: Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up
description: (Assessing change)We will use the short version of the scale, validated in a Spanish clinical sample, with a Cronbach's alpha of 0.76.
measure: Lancashire Quality of Life Profile (LQoLP)
time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
description: (Assessing change)This instrument assesses patient satisfaction with various aspects of their life, work, leisure time, religion, finances, living situation, safety, family relations, social relations, and health, as well as global wellbeing and self-esteem.
arm group label: Study procedure
arm group type: Experimental
description: An experimental group the psychological treatment includes 50 sessions of integrated psychological therapy (IPT) (focused on attentional skills training, social perception skills training, verbal communication skills, social skills training, interpersonal problems solving skills) and 10 sessions of specific emotional management therapy (EMT), designed for this research and based on the contents developed by Hodel, Kern and Brenner.
arm group label: Treatment as usual
arm group type: No Intervention
description: The treatment as usual is pharmacological treatment and activities in a Day Care Center.
intervention type: Behavioral
intervention name: Integrated Psychological Therapy
description: The psychological treatment includes 50 sessions of integrated psychological therapy focused on attentional skills, social perception skills, verbal communication skills, social skills and interpersonal problems solving skills and 10 sessions of specific emotional management therapy , designed for this research. and based on the contents developed by Hodel, Kern and Brenner
arm group label: Study procedure
other name: Emotional Management Therapy
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karmele Salaberria, Ph.D
role: Principal Investigator
affiliation: Lecturer of School of Psychology
responsible party type: Principal Investigator
investigator affiliation: University of the Basque Country (UPV/EHU)
investigator full name: Karmele Salaberria Irizar
investigator title: Phd.-Lecturer
mesh term: Schizophrenia
sharing ipd: Yes
ipd description: to share the study protocol and the clinical study report
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: 2011/2017
ipd access criteria: Researchers
provided document: 
provided document: 
provided document: 