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Preliminary Efficacy of a One-Session Mindfulness Telehealth Intervention for Loneliness

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ClinicalTrials.gov Identifier: NCT04414826
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Loneliness Behavioral: Mindfulness Alone (MO) Intervention Behavioral: Mindfulness + Compassion Intervention (MC) Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Efficacy of a One-Session Mindfulness Telehealth Intervention for Loneliness
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mindfulness + Compassion (MC) Intervention
Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching both mindfulness and compassion skills.
 Behavioral: Mindfulness + Compassion Intervention (MC)
Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.
Active Comparator: Mindfulness Alone (MO) Intervention
Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching mindfulness skills alone.
 Behavioral: Mindfulness Alone (MO) Intervention
Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.
Placebo Comparator: Waitlist Control (WL)
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.
 Behavioral: Mindfulness Alone (MO) Intervention
Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.

Behavioral: Mindfulness + Compassion Intervention (MC)
Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. Perceived Stress Scale (PSS) [ Time Frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21) ]
    Change from baseline in self-reported feelings of stress. Scores range from 0 to 40, with higher scores indicating more perceived stress.


Other Outcome Measures:
  1. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21) ]
    Change from baseline in self-reported anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety.

  2. 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) ]
    Change from baseline in self-reported depressive symptoms. Scores range from 0 to 24, with higher scores indicating higher depressive symptom severity.

  3. Brunnsviken Brief Quality of Life Scale (BBQ) [ Time Frame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21) ]
    Change from baseline in self-reported quality of life. Scores range from 0 to 48, with higher scores indicating better quality of life.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Access to the Internet with teleconferencing for the HIPAA-compliant video platform
  2. Fluent in English
  3. Aged 18 - 70 years old
  4. Currently isolating due to COVID-19
  5. Endorses loneliness as being among the top three issues impacting their life
  6. Demonstrates understanding of the constraints of the intervention (e.g. that it is a single session mindfulness training intervention focused on loneliness).
  7. Has access to a private setting for completing the intervention
  8. Denies suicidality

Exclusion Criteria:

  1. Trauma as a primary concern
  2. Significant depression with depression as a primary concern
  3. Severe mental illness (e.g. bipolar, schizophrenia, borderline personality disorder)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414826


Contacts
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Contact: Michael J Telch, PhD 512-560-4100 telch@austin.utexas.edu
Contact: Mikael Rubin, MA 646-685-4681 mikaelrubin@utexas.edu

Locations
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United States, Texas
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Mikael Rubin, MA         
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Study Director: Michael J Telch, PhD The University of Texas at Austin
Principal Investigator: Mikael Rubin, MA The University of Texas at Austin
More Information
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Additional Information:

Publications:

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Responsible Party: Michael J. Telch, Professor of Psychology, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04414826    
Other Study ID Numbers: 2020-04-0088
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Access Criteria: Data will be made available on osf
URL: https://osf.io/hxj2z/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael J. Telch, University of Texas at Austin:
Loneliness
Mindfulness
Telehealth
COVID-19