<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/NCT04414826</url>
  </required_header>
  <id_info>
    <org_study_id>2020-04-0088</org_study_id>
    <nct_id>NCT04414826</nct_id>
  </id_info>
  <brief_title>Preliminary Efficacy of a One-Session Mindfulness Telehealth Intervention for Loneliness</brief_title>
  <official_title>Preliminary Efficacy of a One-Session Mindfulness Telehealth Intervention for Loneliness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</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 primary aim of this study is to examine the efficacy of a one-session, hour-long&#xD;
      HIPAA-compliant video platform-based mindfulness + compassion telehealth intervention on&#xD;
      reducing feelings of loneliness during COVID-19 quarantine. Participants (n=120) currently&#xD;
      isolating due to COVID-19 will be randomized to one of three interventions: (a) mindfulness +&#xD;
      compassion (MC); (b) mindfulness alone (MO); and (c) waitlist control (WL).&#xD;
&#xD;
      The investigators predict that participants in the active intervention groups (mindfulness or&#xD;
      mindfulness + compassion) will show a significantly greater reduction in subjective feelings&#xD;
      of loneliness at one week follow-up compared to those in the waitlist control group.&#xD;
      Additionally, investigators predict that participants in the active intervention groups will&#xD;
      show a significantly greater reduction in stress at one week follow-up compared to those in&#xD;
      the waitlist control group. Last, investigators predict that participants in the mindfulness&#xD;
      + compassion group will show a significantly greater reduction in subjective feelings of&#xD;
      loneliness at the 2-week follow-up follow-up relative to those in the mindfulness only group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals are currently living in an unprecedented time where they are isolated in their&#xD;
      homes for an extended period due to the ongoing coronavirus disease 2019 (COVID-19) pandemic.&#xD;
      Feelings of loneliness, or perceived social isolation, have often been cited as accompanying&#xD;
      objective social isolation. Prior research has established a link between loneliness and a&#xD;
      variety of mental health outcomes including increased depressive symptoms, increased stress&#xD;
      reactivity, and increased risk of suicidal thoughts and attempts.&#xD;
&#xD;
      The urgency of the COVID-19 pandemic thus necessitates the investigation of potential&#xD;
      short-term interventions for loneliness. Research has suggested that longer-term mindfulness&#xD;
      interventions may be effective in mitigating feelings of loneliness and its concomitant&#xD;
      mental health outcomes. The proposed study seeks to determine the preliminary efficacy of a&#xD;
      one-session mindfulness-based telehealth intervention for loneliness during COVID-19. To&#xD;
      increase the potency of this mindfulness-based intervention, the investigators aim to&#xD;
      incorporate compassion motivated social engagement.&#xD;
&#xD;
      There is ample evidence that mindfulness alone is an effective intervention method for&#xD;
      addressing loneliness. However, inclusion of a compassion component may amplify the effects&#xD;
      of an intervention on loneliness because prior research has found that less compassion is&#xD;
      associated with greater loneliness. To date, no research has explicitly tested the effect of&#xD;
      incorporating compassion into a mindfulness intervention for reducing feelings of loneliness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">November 26, 2021</completion_date>
  <primary_completion_date type="Actual">November 26, 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>
    <intervention_model_description>Participants will be randomized to one of three groups: (a) Mindfulness alone; (b) Mindfulness + Compassion; and (c) Wait-list control.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Revised University of California Los Angeles Loneliness Scale - 8 (ULS-8)</measure>
    <time_frame>Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)</time_frame>
    <description>Change from baseline in self-reported feelings of loneliness and social isolation. Scores range from 8 to 32, with higher scores indicating higher levels of loneliness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)</time_frame>
    <description>Change from baseline in self-reported feelings of stress. Scores range from 0 to 40, with higher scores indicating more perceived stress.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Generalized Anxiety Disorder - 7 (GAD-7)</measure>
    <time_frame>Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)</time_frame>
    <description>Change from baseline in self-reported anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Personal Health Questionnaire Depression Scale - 8 (PHQ-8)</measure>
    <time_frame>Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)</time_frame>
    <description>Change from baseline in self-reported depressive symptoms. Scores range from 0 to 24, with higher scores indicating higher depressive symptom severity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brunnsviken Brief Quality of Life Scale (BBQ)</measure>
    <time_frame>Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)</time_frame>
    <description>Change from baseline in self-reported quality of life. Scores range from 0 to 48, with higher scores indicating better quality of life.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Loneliness</condition>
  <arm_group>
    <arm_group_label>Mindfulness + Compassion (MC) Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching both mindfulness and compassion skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness Alone (MO) Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching mindfulness skills alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control (WL)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Those in the wait-list control condition will wait one week and complete a one-week follow-up assessment before being randomized to one of the two intervention conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Alone (MO) Intervention</intervention_name>
    <description>Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.</description>
    <arm_group_label>Mindfulness Alone (MO) Intervention</arm_group_label>
    <arm_group_label>Waitlist Control (WL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness + Compassion Intervention (MC)</intervention_name>
    <description>Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.</description>
    <arm_group_label>Mindfulness + Compassion (MC) Intervention</arm_group_label>
    <arm_group_label>Waitlist Control (WL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Access to the Internet with teleconferencing for the HIPAA-compliant video platform&#xD;
&#xD;
          2. Fluent in English&#xD;
&#xD;
          3. Aged 18 - 70 years old&#xD;
&#xD;
          4. Currently isolating due to COVID-19&#xD;
&#xD;
          5. Endorses loneliness as being among the top three issues impacting their life&#xD;
&#xD;
          6. Demonstrates understanding of the constraints of the intervention (e.g. that it is a&#xD;
             single session mindfulness training intervention focused on loneliness).&#xD;
&#xD;
          7. Has access to a private setting for completing the intervention&#xD;
&#xD;
          8. Denies suicidality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Trauma as a primary concern&#xD;
&#xD;
          2. Significant depression with depression as a primary concern&#xD;
&#xD;
          3. Severe mental illness (e.g. bipolar, schizophrenia, borderline personality disorder)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Telch, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The University of Texas at Austin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikael Rubin, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory for the Study of Anxiety Disorders, University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://UTanxiety.com</url>
    <description>Website for the Laboratory for the Study of Anxiety Disorders</description>
  </link>
  <reference>
    <citation>Shankar A, McMunn A, Banks J, Steptoe A. Loneliness, social isolation, and behavioral and biological health indicators in older adults. Health Psychol. 2011 Jul;30(4):377-85. doi: 10.1037/a0022826.</citation>
    <PMID>21534675</PMID>
  </reference>
  <reference>
    <citation>Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140.</citation>
    <PMID>16594799</PMID>
  </reference>
  <reference>
    <citation>VanderWeele TJ, Hawkley LC, Thisted RA, Cacioppo JT. A marginal structural model analysis for loneliness: implications for intervention trials and clinical practice. J Consult Clin Psychol. 2011 Apr;79(2):225-35. doi: 10.1037/a0022610.</citation>
    <PMID>21443322</PMID>
  </reference>
  <reference>
    <citation>Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.</citation>
    <PMID>16952717</PMID>
  </reference>
  <reference>
    <citation>Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.</citation>
    <PMID>22820409</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Michael J. Telch</investigator_full_name>
    <investigator_title>Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Loneliness</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Telehealth</keyword>
  <keyword>COVID-19</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_access_criteria>Data will be made available on osf</ipd_access_criteria>
    <ipd_url>https://osf.io/hxj2z/</ipd_url>
  </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/NCT04414826
org study id: 2020-04-0088
nct id: NCT04414826
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to examine the efficacy of a one-session, hour-long
      HIPAA-compliant video platform-based mindfulness + compassion telehealth intervention on
      reducing feelings of loneliness during COVID-19 quarantine. Participants (n=120) currently
      isolating due to COVID-19 will be randomized to one of three interventions: (a) mindfulness +
      compassion (MC); (b) mindfulness alone (MO); and (c) waitlist control (WL).

      The investigators predict that participants in the active intervention groups (mindfulness or
      mindfulness + compassion) will show a significantly greater reduction in subjective feelings
      of loneliness at one week follow-up compared to those in the waitlist control group.
      Additionally, investigators predict that participants in the active intervention groups will
      show a significantly greater reduction in stress at one week follow-up compared to those in
      the waitlist control group. Last, investigators predict that participants in the mindfulness
      + compassion group will show a significantly greater reduction in subjective feelings of
      loneliness at the 2-week follow-up follow-up relative to those in the mindfulness only group.
Individuals are currently living in an unprecedented time where they are isolated in their
      homes for an extended period due to the ongoing coronavirus disease 2019 (COVID-19) pandemic.
      Feelings of loneliness, or perceived social isolation, have often been cited as accompanying
      objective social isolation. Prior research has established a link between loneliness and a
      variety of mental health outcomes including increased depressive symptoms, increased stress
      reactivity, and increased risk of suicidal thoughts and attempts.

      The urgency of the COVID-19 pandemic thus necessitates the investigation of potential
      short-term interventions for loneliness. Research has suggested that longer-term mindfulness
      interventions may be effective in mitigating feelings of loneliness and its concomitant
      mental health outcomes. The proposed study seeks to determine the preliminary efficacy of a
      one-session mindfulness-based telehealth intervention for loneliness during COVID-19. To
      increase the potency of this mindfulness-based intervention, the investigators aim to
      incorporate compassion motivated social engagement.

      There is ample evidence that mindfulness alone is an effective intervention method for
      addressing loneliness. However, inclusion of a compassion component may amplify the effects
      of an intervention on loneliness because prior research has found that less compassion is
      associated with greater loneliness. To date, no research has explicitly tested the effect of
      incorporating compassion into a mindfulness intervention for reducing feelings of loneliness.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to one of three groups: (a) Mindfulness alone; (b) Mindfulness + Compassion; and (c) Wait-list control.
primary purpose: Treatment
masking: None (Open Label)
measure: Revised University of California Los Angeles Loneliness Scale - 8 (ULS-8)
time frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
description: Change from baseline in self-reported feelings of loneliness and social isolation. Scores range from 8 to 32, with higher scores indicating higher levels of loneliness.
measure: Perceived Stress Scale (PSS)
time frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
description: Change from baseline in self-reported feelings of stress. Scores range from 0 to 40, with higher scores indicating more perceived stress.
measure: Generalized Anxiety Disorder - 7 (GAD-7)
time frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
description: Change from baseline in self-reported anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety.
measure: Personal Health Questionnaire Depression Scale - 8 (PHQ-8)
time frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
description: Change from baseline in self-reported depressive symptoms. Scores range from 0 to 24, with higher scores indicating higher depressive symptom severity.
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
time frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
description: Change from baseline in self-reported quality of life. Scores range from 0 to 48, with higher scores indicating better quality of life.
arm group label: Mindfulness + Compassion (MC) Intervention
arm group type: Active Comparator
description: Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching both mindfulness and compassion skills.
arm group label: Mindfulness Alone (MO) Intervention
arm group type: Active Comparator
description: Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching mindfulness skills alone.
arm group label: Waitlist Control (WL)
arm group type: Placebo Comparator
description: Those in the wait-list control condition will wait one week and complete a one-week follow-up assessment before being randomized to one of the two intervention conditions.
intervention type: Behavioral
intervention name: Mindfulness Alone (MO) Intervention
description: Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.
arm group label: Mindfulness Alone (MO) Intervention
arm group label: Waitlist Control (WL)
intervention type: Behavioral
intervention name: Mindfulness + Compassion Intervention (MC)
description: Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.
arm group label: Mindfulness + Compassion (MC) Intervention
arm group label: Waitlist Control (WL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J Telch, PhD
role: Study Director
affiliation: The University of Texas at Austin
last name: Mikael Rubin, MA
role: Principal Investigator
affiliation: The University of Texas at Austin
facility: 
country: United States
url: http://UTanxiety.com
description: Website for the Laboratory for the Study of Anxiety Disorders
citation: Shankar A, McMunn A, Banks J, Steptoe A. Loneliness, social isolation, and behavioral and biological health indicators in older adults. Health Psychol. 2011 Jul;30(4):377-85. doi: 10.1037/a0022826.
PMID: 21534675
citation: Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140.
PMID: 16594799
citation: VanderWeele TJ, Hawkley LC, Thisted RA, Cacioppo JT. A marginal structural model analysis for loneliness: implications for intervention trials and clinical practice. J Consult Clin Psychol. 2011 Apr;79(2):225-35. doi: 10.1037/a0022610.
PMID: 21443322
citation: Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.
PMID: 16952717
citation: Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.
PMID: 22820409
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Michael J. Telch
investigator title: Professor of Psychology
sharing ipd: Yes
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd access criteria: Data will be made available on osf
ipd url: https://osf.io/hxj2z/