<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/NCT03261557</url>
  </required_header>
  <id_info>
    <org_study_id>DN040595</org_study_id>
    <nct_id>NCT03261557</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Social Skills Training in Early Onset Psychosis</brief_title>
  <official_title>Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended&#xD;
      psychological interventions to improve symptomatology and functional recovery in psychosis.&#xD;
      In addition, CBT may reduce hyperactivation of the brain structures responsible for the&#xD;
      stress response. In patients with early onset psychotic disorder (EOP) there are not any&#xD;
      previous controlled study that has analyzed the efficacy of this type of intervention.&#xD;
&#xD;
      The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional&#xD;
      improvement after the treatment in patients with EOP. The study will also examine the&#xD;
      potential effect of the intervention on neurobiological stress markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a&#xD;
      worse clinical and psychosocial evolution than in the adult form of the illness. In the case&#xD;
      of patients with EOP, international and national clinical guidelines recommend the&#xD;
      combination of pharmacological treatment with CBT. However there are not any previous&#xD;
      controlled study that has analyzed the efficacy of this type of psychological intervention.&#xD;
&#xD;
      A controlled randomized study will be carry out of CBT + SST intervention compared to a&#xD;
      control intervention of the same duration, format and contact with a therapist. The sample&#xD;
      will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or&#xD;
      psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to&#xD;
      be in the early phase of the disease (first 5 years after the onset) and in non-acute&#xD;
      treatment. All participants will be evaluated before and after the intervention with clinical&#xD;
      scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age,&#xD;
      puberal stage and sex will be also recruited and evaluated only at baseline point. The&#xD;
      evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be&#xD;
      carry out using the statistical package SPSS v 20.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psychosocial functioning</measure>
    <time_frame>15 weeks</time_frame>
    <description>Change from baseline in social functioning questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical symptoms</measure>
    <time_frame>15 weeks</time_frame>
    <description>Change from baseline in Clinical scales</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biological stress markers</measure>
    <time_frame>15 weeks</time_frame>
    <description>Change pre-post interventionbiological stress markers registered by blood analyses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective stress</measure>
    <time_frame>15 weeks</time_frame>
    <description>Change pre-post intervention in questionnaires of perceived stress</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <condition>Psychosis NOS</condition>
  <arm_group>
    <arm_group_label>CBT + SST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation, habits and healthy lifestyle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT + SST</intervention_name>
    <description>It will consist of 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: cognitive skills module, which includes the basic principles of CBT for psychosis; Social skills module, which includes the usual strategies in HHSS training; and problem solving module.&#xD;
All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.</description>
    <arm_group_label>CBT + SST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation, habits and healthy lifestyle</intervention_name>
    <description>Patients randomized to the control treatment will receive the same number of Individual and group sessions, with the same periodicity and format: 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: psychoeducation, habits and healthy lifestyle.&#xD;
All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.</description>
    <arm_group_label>Psychoeducation, habits and healthy lifestyle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of&#xD;
             9 and 18 (Schizophrenia, schizoaffective disorder or psychotic disorder not otherwise&#xD;
             specified according to DSM-V criteria).&#xD;
&#xD;
          -  Critical period after the first psychotic episode (which covers the first 5 years) and&#xD;
             in non-acute treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ &lt;70&#xD;
&#xD;
          -  Toxic dependence comorbid disorder&#xD;
&#xD;
          -  Presence of Neurological disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Puig, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olga Puig, PhD</last_name>
    <phone>93 227 99 74</phone>
    <email>opuig@clinic.ub.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Child and Adolescent Pyshicatry and Psychology</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olga Puig, PhD</last_name>
      <phone>34 227</phone>
      <phone_ext>99 74</phone_ext>
      <email>opuig@clinic.ub.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Olga Puig</investigator_full_name>
    <investigator_title>Clinical psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</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/NCT03261557
org study id: DN040595
nct id: NCT03261557
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended
      psychological interventions to improve symptomatology and functional recovery in psychosis.
      In addition, CBT may reduce hyperactivation of the brain structures responsible for the
      stress response. In patients with early onset psychotic disorder (EOP) there are not any
      previous controlled study that has analyzed the efficacy of this type of intervention.

      The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional
      improvement after the treatment in patients with EOP. The study will also examine the
      potential effect of the intervention on neurobiological stress markers.
Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a
      worse clinical and psychosocial evolution than in the adult form of the illness. In the case
      of patients with EOP, international and national clinical guidelines recommend the
      combination of pharmacological treatment with CBT. However there are not any previous
      controlled study that has analyzed the efficacy of this type of psychological intervention.

      A controlled randomized study will be carry out of CBT + SST intervention compared to a
      control intervention of the same duration, format and contact with a therapist. The sample
      will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or
      psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to
      be in the early phase of the disease (first 5 years after the onset) and in non-acute
      treatment. All participants will be evaluated before and after the intervention with clinical
      scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age,
      puberal stage and sex will be also recruited and evaluated only at baseline point. The
      evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be
      carry out using the statistical package SPSS v 20.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Psychosocial functioning
time frame: 15 weeks
description: Change from baseline in social functioning questionnaires
measure: Clinical symptoms
time frame: 15 weeks
description: Change from baseline in Clinical scales
measure: Biological stress markers
time frame: 15 weeks
description: Change pre-post interventionbiological stress markers registered by blood analyses
measure: Subjective stress
time frame: 15 weeks
description: Change pre-post intervention in questionnaires of perceived stress
arm group label: CBT + SST
arm group type: Experimental
description: The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.
arm group label: Psychoeducation, habits and healthy lifestyle
arm group type: Active Comparator
description: The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.
intervention type: Behavioral
intervention name: CBT + SST
description: It will consist of 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: cognitive skills module, which includes the basic principles of CBT for psychosis; Social skills module, which includes the usual strategies in HHSS training; and problem solving module.
All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.
arm group label: CBT + SST
intervention type: Behavioral
intervention name: Psychoeducation, habits and healthy lifestyle
description: Patients randomized to the control treatment will receive the same number of Individual and group sessions, with the same periodicity and format: 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: psychoeducation, habits and healthy lifestyle.
All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.
arm group label: Psychoeducation, habits and healthy lifestyle
criteria: 
gender: All
minimum age: 12 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olga Puig, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Olga Puig, PhD
phone: 93 227 99 74
email: opuig@clinic.ub.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Olga Puig
investigator title: Clinical psychologist
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Mental Disorders