<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/NCT04469049</url>
  </required_header>
  <id_info>
    <org_study_id>MZHF_20200962</org_study_id>
    <nct_id>NCT04469049</nct_id>
  </id_info>
  <brief_title>MBCT for People With Parkinson's Disease and Caregivers</brief_title>
  <acronym>MBCT-PD-2</acronym>
  <official_title>Mindfulness-based Cognitive Therapy for People With Parkinson's Disease and Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Zion Health Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
      This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive&#xD;
      therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's&#xD;
      disease (PD) and caregivers of people with PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An adapted MBCT intervention will be offered to people with Parkinson's disease (PD) and&#xD;
      mild-to-moderate depression and/or anxiety, as well as caregivers of people with PD. Several&#xD;
      8-week long MBCT groups will be held between September 2020 and May 2021, based on the&#xD;
      adapted protocol. The MBCT intervention will consist of 90-minute weekly groups focused on&#xD;
      teaching mindfulness techniques and ways to recognize cognitive patterns that can increase&#xD;
      anxiety and/or depression. Participants will be recruited from the community, according to&#xD;
      the eligibility criteria detailed below. For all participants, the pre- and post-MBCT anxiety&#xD;
      and/or depressive symptom severity and mindfulness levels (as measured with standardized,&#xD;
      validated scales) will be compared, using a paired t-test. For caregivers, pre- and post-MBCT&#xD;
      caregiver burden scores will be compared as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants will receive the MBCT intervention, however they will be separated in several distinct groups over time, due to MBCT protocol limitations.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anxiety symptom severity</measure>
    <time_frame>From pre- to post-MBCT 8 weeks later</time_frame>
    <description>Change in Generalized Anxiety Disorder-7 item score (for participants with anxiety). The scale score range is 0-21, with higher scores indicating more severe anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depressive symptom severity</measure>
    <time_frame>From pre- to post-MBCT 8 weeks later</time_frame>
    <description>Change in Patient Health Questionnaire-9 score (for participants with depression). The scale score range is 0-27, with higher scores indicating more severe depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mindfulness levels</measure>
    <time_frame>From pre- to post-MBCT 8 weeks later</time_frame>
    <description>Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver burden score (caregivers only)</measure>
    <time_frame>From pre- to post-MBCT 8 weeks later</time_frame>
    <description>Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based cognitive therapy (MBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based cognitive therapy (MBCT)</intervention_name>
    <description>MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.</description>
    <arm_group_label>Mindfulness-based cognitive therapy (MBCT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a diagnosis of Parkinson's disease (PD) or parkinsonism, established by a&#xD;
             neurologist, or being a caregiver of a person with PD or parkinsonism&#xD;
&#xD;
          -  Being able and willing to attend 8 weekly 90-minute online group sessions (5-6:30 pm&#xD;
             PST)&#xD;
&#xD;
          -  Mild-to-moderate anxiety: GAD-7 score ≤ 16&#xD;
&#xD;
          -  Mild-to-moderate depression: PHQ-9 score ≤ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe anxiety: GAD-7 score &gt; 16&#xD;
&#xD;
          -  Moderately severe-to-severe depression: PHQ-9 score &gt; 18&#xD;
&#xD;
          -  Cognitive impairment: Montreal Cognitive Assessment (MoCA) score &lt; 24&#xD;
&#xD;
          -  Heavy alcohol or drug use&#xD;
&#xD;
          -  Severe psychosis&#xD;
&#xD;
          -  Active suicidal or homicidal ideation&#xD;
&#xD;
          -  For people with PD: severe motor fluctuations (less than 2 hours &quot;on&quot; time per day)&#xD;
&#xD;
          -  Pattern of engagement with health care that indicates low likelihood of completing an&#xD;
             8-week intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreea L. Seritan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chaudhuri KR, Healy DG, Schapira AH; National Institute for Clinical Excellence. Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurol. 2006 Mar;5(3):235-45. doi: 10.1016/S1474-4422(06)70373-8.</citation>
    <PMID>16488379</PMID>
  </reference>
  <reference>
    <citation>Broen MP, Narayen NE, Kuijf ML, Dissanayaka NN, Leentjens AF. Prevalence of anxiety in Parkinson's disease: A systematic review and meta-analysis. Mov Disord. 2016 Aug;31(8):1125-33. doi: 10.1002/mds.26643. Epub 2016 Apr 29.</citation>
    <PMID>27125963</PMID>
  </reference>
  <reference>
    <citation>Reijnders JS, Ehrt U, Weber WE, Aarsland D, Leentjens AF. A systematic review of prevalence studies of depression in Parkinson's disease. Mov Disord. 2008 Jan 30;23(2):183-9; quiz 313. doi: 10.1002/mds.21803.</citation>
    <PMID>17987654</PMID>
  </reference>
  <reference>
    <citation>Martinez-Fernandez R, Schmitt E, Martinez-Martin P, Krack P. The hidden sister of motor fluctuations in Parkinson's disease: A review on nonmotor fluctuations. Mov Disord. 2016 Aug;31(8):1080-94. doi: 10.1002/mds.26731. Epub 2016 Jul 19.</citation>
    <PMID>27431515</PMID>
  </reference>
  <reference>
    <citation>Seritan AL, Ureste PJ, Duong T, Ostrem JL. Psychopharmacology for patients with Parkinson's disease and deep brain stimulation: Lessons learned in an academic center. Current Psychopharmacology 8(1):41-54, 2019 DOI: 10.2174/2211556007666180328142953</citation>
  </reference>
  <reference>
    <citation>Gotink RA, Chu P, Busschbach JJ, Benson H, Fricchione GL, Hunink MG. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015 Apr 16;10(4):e0124344. doi: 10.1371/journal.pone.0124344. eCollection 2015.</citation>
    <PMID>25881019</PMID>
  </reference>
  <reference>
    <citation>Cash TV, Ekouevi VS, Kilbourn C, Lageman SK. Pilot study of a mindfulness-based group intervention for individuals with Parkinson's disease and their caregivers. Mindfulness 7: 361-371, 2016</citation>
  </reference>
  <reference>
    <citation>Pickut B, Vanneste S, Hirsch MA, Van Hecke W, Kerckhofs E, Marien P, Parizel PM, Crosiers D, Cras P. Mindfulness Training among Individuals with Parkinson's Disease: Neurobehavioral Effects. Parkinsons Dis. 2015;2015:816404. doi: 10.1155/2015/816404. Epub 2015 May 26.</citation>
    <PMID>26101690</PMID>
  </reference>
  <reference>
    <citation>Dissanayaka NN, Idu Jion F, Pachana NA, O'Sullivan JD, Marsh R, Byrne GJ, Harnett P. Mindfulness for Motor and Nonmotor Dysfunctions in Parkinson's Disease. Parkinsons Dis. 2016;2016:7109052. doi: 10.1155/2016/7109052. Epub 2016 Apr 10.</citation>
    <PMID>27144052</PMID>
  </reference>
  <reference>
    <citation>Fitzpatrick L, Simpson J, Smith A. A qualitative analysis of mindfulness-based cognitive therapy (MBCT) in Parkinson's disease. Psychol Psychother. 2010 Jun;83(Pt 2):179-92. doi: 10.1348/147608309X471514. Epub 2009 Oct 19.</citation>
    <PMID>19843353</PMID>
  </reference>
  <reference>
    <citation>Rodgers SH, Schutze R, Gasson N, Anderson RA, Kane RT, Starkstein S, Morgan-Lowes K, Egan SJ. Modified Mindfulness-Based Cognitive Therapy for Depressive Symptoms in Parkinson's Disease: a Pilot Trial. Behav Cogn Psychother. 2019 Jul;47(4):446-461. doi: 10.1017/S135246581800070X. Epub 2019 Jan 18.</citation>
    <PMID>30654854</PMID>
  </reference>
  <reference>
    <citation>Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.</citation>
    <PMID>10965637</PMID>
  </reference>
  <reference>
    <citation>Evans S, Ferrando S, Findler M, Stowell C, Smart C, Haglin D. Mindfulness-based cognitive therapy for generalized anxiety disorder. J Anxiety Disord. 2008 May;22(4):716-21. doi: 10.1016/j.janxdis.2007.07.005. Epub 2007 Jul 22.</citation>
    <PMID>17765453</PMID>
  </reference>
  <reference>
    <citation>Eisendrath SJ, Gillung E, Delucchi KL, Segal ZV, Nelson JC, McInnes LA, Mathalon DH, Feldman MD. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression. Psychother Psychosom. 2016;85(2):99-110. doi: 10.1159/000442260. Epub 2016 Jan 26.</citation>
    <PMID>26808973</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Mindfulness-based intervention</keyword>
  <keyword>Mindfulness-based cognitive therapy (MBCT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04469049
org study id: MZHF_20200962
nct id: NCT04469049
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive
      therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's
      disease (PD) and caregivers of people with PD.
An adapted MBCT intervention will be offered to people with Parkinson's disease (PD) and
      mild-to-moderate depression and/or anxiety, as well as caregivers of people with PD. Several
      8-week long MBCT groups will be held between September 2020 and May 2021, based on the
      adapted protocol. The MBCT intervention will consist of 90-minute weekly groups focused on
      teaching mindfulness techniques and ways to recognize cognitive patterns that can increase
      anxiety and/or depression. Participants will be recruited from the community, according to
      the eligibility criteria detailed below. For all participants, the pre- and post-MBCT anxiety
      and/or depressive symptom severity and mindfulness levels (as measured with standardized,
      validated scales) will be compared, using a paired t-test. For caregivers, pre- and post-MBCT
      caregiver burden scores will be compared as well.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will receive the MBCT intervention, however they will be separated in several distinct groups over time, due to MBCT protocol limitations.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in anxiety symptom severity
time frame: From pre- to post-MBCT 8 weeks later
description: Change in Generalized Anxiety Disorder-7 item score (for participants with anxiety). The scale score range is 0-21, with higher scores indicating more severe anxiety.
measure: Change in depressive symptom severity
time frame: From pre- to post-MBCT 8 weeks later
description: Change in Patient Health Questionnaire-9 score (for participants with depression). The scale score range is 0-27, with higher scores indicating more severe depression.
measure: Change in mindfulness levels
time frame: From pre- to post-MBCT 8 weeks later
description: Change in 15 item-Five Facet Mindfulness Questionnaire score. The scale score range is 0-75, with higher scores indicating higher mindfulness levels.
measure: Change in caregiver burden score (caregivers only)
time frame: From pre- to post-MBCT 8 weeks later
description: Change in AMA Caregiver Self-Assessment Questionnaire score. The scale score range is 0-16, with higher scores indicating higher caregiver burden.
arm group label: Mindfulness-based cognitive therapy (MBCT)
arm group type: Experimental
description: All participants will receive the MBCT intervention, consisting of 8 90-minute weekly group sessions.
intervention type: Behavioral
intervention name: Mindfulness-based cognitive therapy (MBCT)
description: MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
arm group label: Mindfulness-based cognitive therapy (MBCT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andreea L. Seritan, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Chaudhuri KR, Healy DG, Schapira AH; National Institute for Clinical Excellence. Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurol. 2006 Mar;5(3):235-45. doi: 10.1016/S1474-4422(06)70373-8.
PMID: 16488379
citation: Broen MP, Narayen NE, Kuijf ML, Dissanayaka NN, Leentjens AF. Prevalence of anxiety in Parkinson's disease: A systematic review and meta-analysis. Mov Disord. 2016 Aug;31(8):1125-33. doi: 10.1002/mds.26643. Epub 2016 Apr 29.
PMID: 27125963
citation: Reijnders JS, Ehrt U, Weber WE, Aarsland D, Leentjens AF. A systematic review of prevalence studies of depression in Parkinson's disease. Mov Disord. 2008 Jan 30;23(2):183-9; quiz 313. doi: 10.1002/mds.21803.
PMID: 17987654
citation: Martinez-Fernandez R, Schmitt E, Martinez-Martin P, Krack P. The hidden sister of motor fluctuations in Parkinson's disease: A review on nonmotor fluctuations. Mov Disord. 2016 Aug;31(8):1080-94. doi: 10.1002/mds.26731. Epub 2016 Jul 19.
PMID: 27431515
citation: Seritan AL, Ureste PJ, Duong T, Ostrem JL. Psychopharmacology for patients with Parkinson's disease and deep brain stimulation: Lessons learned in an academic center. Current Psychopharmacology 8(1):41-54, 2019 DOI: 10.2174/2211556007666180328142953
citation: Gotink RA, Chu P, Busschbach JJ, Benson H, Fricchione GL, Hunink MG. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015 Apr 16;10(4):e0124344. doi: 10.1371/journal.pone.0124344. eCollection 2015.
PMID: 25881019
citation: Cash TV, Ekouevi VS, Kilbourn C, Lageman SK. Pilot study of a mindfulness-based group intervention for individuals with Parkinson's disease and their caregivers. Mindfulness 7: 361-371, 2016
citation: Pickut B, Vanneste S, Hirsch MA, Van Hecke W, Kerckhofs E, Marien P, Parizel PM, Crosiers D, Cras P. Mindfulness Training among Individuals with Parkinson's Disease: Neurobehavioral Effects. Parkinsons Dis. 2015;2015:816404. doi: 10.1155/2015/816404. Epub 2015 May 26.
PMID: 26101690
citation: Dissanayaka NN, Idu Jion F, Pachana NA, O'Sullivan JD, Marsh R, Byrne GJ, Harnett P. Mindfulness for Motor and Nonmotor Dysfunctions in Parkinson's Disease. Parkinsons Dis. 2016;2016:7109052. doi: 10.1155/2016/7109052. Epub 2016 Apr 10.
PMID: 27144052
citation: Fitzpatrick L, Simpson J, Smith A. A qualitative analysis of mindfulness-based cognitive therapy (MBCT) in Parkinson's disease. Psychol Psychother. 2010 Jun;83(Pt 2):179-92. doi: 10.1348/147608309X471514. Epub 2009 Oct 19.
PMID: 19843353
citation: Rodgers SH, Schutze R, Gasson N, Anderson RA, Kane RT, Starkstein S, Morgan-Lowes K, Egan SJ. Modified Mindfulness-Based Cognitive Therapy for Depressive Symptoms in Parkinson's Disease: a Pilot Trial. Behav Cogn Psychother. 2019 Jul;47(4):446-461. doi: 10.1017/S135246581800070X. Epub 2019 Jan 18.
PMID: 30654854
citation: Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PMID: 10965637
citation: Evans S, Ferrando S, Findler M, Stowell C, Smart C, Haglin D. Mindfulness-based cognitive therapy for generalized anxiety disorder. J Anxiety Disord. 2008 May;22(4):716-21. doi: 10.1016/j.janxdis.2007.07.005. Epub 2007 Jul 22.
PMID: 17765453
citation: Eisendrath SJ, Gillung E, Delucchi KL, Segal ZV, Nelson JC, McInnes LA, Mathalon DH, Feldman MD. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression. Psychother Psychosom. 2016;85(2):99-110. doi: 10.1159/000442260. Epub 2016 Jan 26.
PMID: 26808973
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No