<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/NCT04476771</url>
  </required_header>
  <id_info>
    <org_study_id>ComplutenseMadrid</org_study_id>
    <nct_id>NCT04476771</nct_id>
  </id_info>
  <brief_title>Cultivating Well-being in Subclinical Paranoia</brief_title>
  <official_title>Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</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>
      The intervention is called Feliz-Mente, with third generation therapy components that aims to&#xD;
      improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is&#xD;
      expected to increase positive experiences, the use of personal strengths and positive&#xD;
      relationships, and aims to build a more meaningful self-narrative in persons with subclinical&#xD;
      paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are&#xD;
      expected to perform exercises during and between sessions by the use of a mobile application&#xD;
      to improve treatment adherence and daily practice. The design for the present study is a&#xD;
      randomized controlled trial, which compares the post-intervention measures of the&#xD;
      experimental group (group receiving the intervention and the daily use of a mobile&#xD;
      application of the program) with the post-intervention measures of the control group&#xD;
      (treatment as usual + waiting list).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">September 25, 2019</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>Change from Well-being at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Psychological Well-Being Scales (Ryff, 1995)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Well-being at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Satisfaction with life Scale ( Diener et al. 1985)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Well-beingDistress at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Hospital Anxiety and Depression Scale (Bjelland et al. 2002)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from self-esteem at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Implicit self-esteem version: Go/No-Go Association Task (Nosek &amp; Banaji, 2001)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from self-esteem at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Rosenberg self-esteem scale (Rosenberg, 1965)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Attachment at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Relationship Questionnaire (Bartholomew and Horowitz, 1991)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Paranoid ideation at 12 weeks, 3 months and 12 months</measure>
    <time_frame>Change baseline, 12 weeks, 3 months and 12 months</time_frame>
    <description>Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>additional Outcome Measures Experience of trauma events</measure>
    <time_frame>baseline</time_frame>
    <description>Life Events Checklist for DSM-5 (Gray, 2004)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Wellbeing</condition>
  <arm_group>
    <arm_group_label>TAU + waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU + Feliz-Mente Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feliz-Mente (third generation psychotherapy)</intervention_name>
    <description>The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.</description>
    <arm_group_label>TAU + Feliz-Mente Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants between 18 and 35 years old&#xD;
&#xD;
          -  At least two standard deviations above mean on the scales of distress, suspicion and&#xD;
             /or interpersonal sensitivity in the SCL-90 questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with borderline personality disorder&#xD;
&#xD;
          -  Participants with substance use disorders and /or&#xD;
&#xD;
          -  Participants with severe cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Carmen Valiente</name>
      <address>
        <city>Pozuelo de Alarcón</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Complutense de Madrid</investigator_affiliation>
    <investigator_full_name>Carmen Valiente Ots</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paranoid Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </patient_data>
  <!-- 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/NCT04476771
org study id: ComplutenseMadrid
nct id: NCT04476771
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The intervention is called Feliz-Mente, with third generation therapy components that aims to
      improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is
      expected to increase positive experiences, the use of personal strengths and positive
      relationships, and aims to build a more meaningful self-narrative in persons with subclinical
      paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are
      expected to perform exercises during and between sessions by the use of a mobile application
      to improve treatment adherence and daily practice. The design for the present study is a
      randomized controlled trial, which compares the post-intervention measures of the
      experimental group (group receiving the intervention and the daily use of a mobile
      application of the program) with the post-intervention measures of the control group
      (treatment as usual + waiting list).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Well-being at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Psychological Well-Being Scales (Ryff, 1995)
measure: Change from Well-being at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Satisfaction with life Scale ( Diener et al. 1985)
measure: Change from Well-beingDistress at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Hospital Anxiety and Depression Scale (Bjelland et al. 2002)
measure: Change from self-esteem at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Implicit self-esteem version: Go/No-Go Association Task (Nosek & Banaji, 2001)
measure: Change from self-esteem at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Rosenberg self-esteem scale (Rosenberg, 1965)
measure: Change from Attachment at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Relationship Questionnaire (Bartholomew and Horowitz, 1991)
measure: Change from Paranoid ideation at 12 weeks, 3 months and 12 months
time frame: Change baseline, 12 weeks, 3 months and 12 months
description: Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)
measure: additional Outcome Measures Experience of trauma events
time frame: baseline
description: Life Events Checklist for DSM-5 (Gray, 2004)
arm group label: TAU + waiting list
arm group type: No Intervention
description: Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.
arm group label: TAU + Feliz-Mente Intervention
arm group type: Experimental
description: Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.
intervention type: Behavioral
intervention name: Feliz-Mente (third generation psychotherapy)
description: The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.
arm group label: TAU + Feliz-Mente Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Complutense de Madrid
investigator full name: Carmen Valiente Ots
investigator title: Principal Investigator
mesh term: Paranoid Disorders
sharing ipd: Yes
ipd description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code