<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/NCT04420000</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-MIN-2020-16</org_study_id>
    <nct_id>NCT04420000</nct_id>
  </id_info>
  <brief_title>Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing</brief_title>
  <official_title>Effects of Mindfulness Therapy in Patients With Acromegaly and in Patients With Cushing's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>A.O. Ospedale Papa Giovanni XXIII</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Consorcio Centro de Investigación Biomédica en Red (CIBER)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</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>
      Randomized, multicenter, international clinical trial (one center in Barcelona and one center&#xD;
      in Bergamo, Italy), with exploratory intention.&#xD;
&#xD;
      The main objective of the study will be to assess changes in quality of life, mood, chronic&#xD;
      pain and sleep after the delivery of a Mindfulness program.&#xD;
&#xD;
      The secondary objectives will be: to evaluate if this program also affects blood pressure, if&#xD;
      the changes are maintained six months after treatment and if it determines the decrease in&#xD;
      health resources used.&#xD;
&#xD;
      The intervention group will do Mindfulness sessions according to an established protocol of 8&#xD;
      weeks, while the control group will follow the normal clinical routine. The Mindfulness&#xD;
      protocol will be carried out in group sessions led by a therapist with experience in&#xD;
      mindfulness and compassion, lasting 120 minutes, weekly, which will take place over 8 weeks.&#xD;
&#xD;
      Two separate studies will be done, one for patients with acromegaly which will be the first&#xD;
      to take place and then another for patients with Cushing's syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty patients with acromegaly, (30 in Spain and 30 in Italy) and 60 patients with Cushing&#xD;
      syndrome (30 in Spain and 30 in Italy), who are visited in the Endocrinology services of the&#xD;
      Hospital de la Santa Creu i Sant Pau, Barcelona and Papa Giovanni XXIII in Bergamo will&#xD;
      participate in the study.&#xD;
&#xD;
      In each center there will be 30 patients for each pathology (15 will participate in the&#xD;
      Mindfulness intervention group and 15 will receive the usual treatment).&#xD;
&#xD;
      Inclusion criteria: 1) age between 18 and 70 years, 2) diagnosis of acromegaly, 3) diagnosis&#xD;
      of Cushing's syndrome, 4) patients with controlled disease, 5) not currently participating in&#xD;
      any other clinical study.&#xD;
&#xD;
      Exclusion criteria: 1) physical illnesses or comorbidity of serious mental illness that&#xD;
      impede the practice of Mindfulness, 2) Patients who for cognitive, neurological or&#xD;
      psychiatric reasons could not follow the sessions 3) Patients who do not accept signing the&#xD;
      informed consent 4) Patients with Cushing's syndrome or active acromegaly, 5) Simultaneous&#xD;
      participation in another clinical study.&#xD;
&#xD;
      Patients who meet the inclusion / exclusion criteria will be invited to participate in the&#xD;
      study. The Patient Information Sheet (HIP) and Informed Consent (CI) will be provided. There&#xD;
      will be three evaluation visits (pre and post intervention, and 6 months after the&#xD;
      intervention) in which the participants must complete different questionnaires and scales.&#xD;
      Participants will be invited to keep a daily practice log, and will be required to complete&#xD;
      the assigned daily meditation practices for the 8-week program.&#xD;
&#xD;
      Demographic and clinical variables (collected from the medical history) will be included.&#xD;
      Patients will also have their blood pressure taken before and after each session.&#xD;
&#xD;
      Questionnaires:&#xD;
&#xD;
        -  Quality of Life: AcroQoL (patients with acromegaly), CushingQoL (patients with Cushing&#xD;
           syndrome)&#xD;
&#xD;
        -  Mood: Hospital Anxiety and Depression Scale (HADS)&#xD;
&#xD;
        -  Sleep: Pittsburgh Sleep Quality Index&#xD;
&#xD;
        -  Pain: McGill Pain Questionnaire&#xD;
&#xD;
        -  Self Compassion Scale (SCS)&#xD;
&#xD;
        -  Life satisfaction scale (SWLS)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in quality of life in patients with acromegaly</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>using the Acromegaly Quality of Life Questionnaire (AcroQoL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life in patients with Cushing's syndrome</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>using the Cushing's Quality-of-Life (CushingQOL) questionnaire</description>
  </primary_outcome>
  <other_outcome>
    <measure>Change in Pain in patients with acromegaly and Cushing's syndrome</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>as evaluated using the McGill Pain Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Mood in patients with acromegaly and Cushing's syndrome</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>as evaluate using Hospital Anxiety and Depression Scale (HADS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Sleep in patients with acromegaly and Cushing's syndrome</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>as evaluate using Pittsburgh sleep scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Self compassion in patients with acromegaly and Cushing's syndrome</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>as evaluate using Self Compassion Scale (SCS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfation with life in patients with acromegaly and Cushing's syndrome</measure>
    <time_frame>Baseline, post-intervention (8 weeks)</time_frame>
    <description>as evaluate using SWLS questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients having a Mindfulness program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients having a routinary managment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>Mindfulness based programme</description>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Treatment as usual</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of controlled acromegaly,&#xD;
&#xD;
          -  Clinical diagnosis of controlled Cushing syndrome&#xD;
&#xD;
          -  Must be able to perform Mindfulness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Previous experience with Mindfulness&#xD;
&#xD;
          -  Participation in other clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugenia Resmini, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ciberer and IIB Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Resmini Eugenia</name>
      <address>
        <city>Barcelona</city>
        <zip>08014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Acromgaly</keyword>
  <keyword>Cushing</keyword>
  <keyword>Quality Of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acromegaly</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We'll publish the data after completing the study</ipd_description>
  </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/NCT04420000
org study id: IIBSP-MIN-2020-16
nct id: NCT04420000
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized, multicenter, international clinical trial (one center in Barcelona and one center
      in Bergamo, Italy), with exploratory intention.

      The main objective of the study will be to assess changes in quality of life, mood, chronic
      pain and sleep after the delivery of a Mindfulness program.

      The secondary objectives will be: to evaluate if this program also affects blood pressure, if
      the changes are maintained six months after treatment and if it determines the decrease in
      health resources used.

      The intervention group will do Mindfulness sessions according to an established protocol of 8
      weeks, while the control group will follow the normal clinical routine. The Mindfulness
      protocol will be carried out in group sessions led by a therapist with experience in
      mindfulness and compassion, lasting 120 minutes, weekly, which will take place over 8 weeks.

      Two separate studies will be done, one for patients with acromegaly which will be the first
      to take place and then another for patients with Cushing's syndrome.
Sixty patients with acromegaly, (30 in Spain and 30 in Italy) and 60 patients with Cushing
      syndrome (30 in Spain and 30 in Italy), who are visited in the Endocrinology services of the
      Hospital de la Santa Creu i Sant Pau, Barcelona and Papa Giovanni XXIII in Bergamo will
      participate in the study.

      In each center there will be 30 patients for each pathology (15 will participate in the
      Mindfulness intervention group and 15 will receive the usual treatment).

      Inclusion criteria: 1) age between 18 and 70 years, 2) diagnosis of acromegaly, 3) diagnosis
      of Cushing's syndrome, 4) patients with controlled disease, 5) not currently participating in
      any other clinical study.

      Exclusion criteria: 1) physical illnesses or comorbidity of serious mental illness that
      impede the practice of Mindfulness, 2) Patients who for cognitive, neurological or
      psychiatric reasons could not follow the sessions 3) Patients who do not accept signing the
      informed consent 4) Patients with Cushing's syndrome or active acromegaly, 5) Simultaneous
      participation in another clinical study.

      Patients who meet the inclusion / exclusion criteria will be invited to participate in the
      study. The Patient Information Sheet (HIP) and Informed Consent (CI) will be provided. There
      will be three evaluation visits (pre and post intervention, and 6 months after the
      intervention) in which the participants must complete different questionnaires and scales.
      Participants will be invited to keep a daily practice log, and will be required to complete
      the assigned daily meditation practices for the 8-week program.

      Demographic and clinical variables (collected from the medical history) will be included.
      Patients will also have their blood pressure taken before and after each session.

      Questionnaires:

        -  Quality of Life: AcroQoL (patients with acromegaly), CushingQoL (patients with Cushing
           syndrome)

        -  Mood: Hospital Anxiety and Depression Scale (HADS)

        -  Sleep: Pittsburgh Sleep Quality Index

        -  Pain: McGill Pain Questionnaire

        -  Self Compassion Scale (SCS)

        -  Life satisfaction scale (SWLS)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in quality of life in patients with acromegaly
time frame: Baseline, post-intervention (8 weeks)
description: using the Acromegaly Quality of Life Questionnaire (AcroQoL)
measure: Change in quality of life in patients with Cushing's syndrome
time frame: Baseline, post-intervention (8 weeks)
description: using the Cushing's Quality-of-Life (CushingQOL) questionnaire
measure: Change in Pain in patients with acromegaly and Cushing's syndrome
time frame: Baseline, post-intervention (8 weeks)
description: as evaluated using the McGill Pain Questionnaire
measure: Change in Mood in patients with acromegaly and Cushing's syndrome
time frame: Baseline, post-intervention (8 weeks)
description: as evaluate using Hospital Anxiety and Depression Scale (HADS)
measure: Change in Sleep in patients with acromegaly and Cushing's syndrome
time frame: Baseline, post-intervention (8 weeks)
description: as evaluate using Pittsburgh sleep scale
measure: Self compassion in patients with acromegaly and Cushing's syndrome
time frame: Baseline, post-intervention (8 weeks)
description: as evaluate using Self Compassion Scale (SCS)
measure: Satisfation with life in patients with acromegaly and Cushing's syndrome
time frame: Baseline, post-intervention (8 weeks)
description: as evaluate using SWLS questionnaire
arm group label: Interventional group
arm group type: Experimental
description: Patients having a Mindfulness program
arm group label: Control group
arm group type: Placebo Comparator
description: Patients having a routinary managment
intervention type: Behavioral
intervention name: Mindfulness
description: Mindfulness based programme
arm group label: Interventional group
intervention type: Other
intervention name: Control
description: Treatment as usual
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Eugenia Resmini, MD, PhD
role: Principal Investigator
affiliation: Ciberer and IIB Sant Pau
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Acromegaly
sharing ipd: No
ipd description: We'll publish the data after completing the study