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

May 30, 2022 updated by: Michael J. Telch, University of Texas at Austin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
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.
Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
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.
Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Study Director: Michael J Telch, PhD, The University of Texas at Austin
  • Principal Investigator: Mikael Rubin, MA, The University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

November 26, 2021

Study Completion (Actual)

November 26, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-04-0088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Access Criteria

Data will be made available on osf

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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