Clinical trial NCT04414826: Preliminary Efficacy of a One-Session Mindfulness Telehealth Intervention for Loneliness
Official title: Preliminary Efficacy of a One-Session Mindfulness Telehealth Intervention for Loneliness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Keywords: Loneliness
Mindfulness
Telehealth
COVID-19
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility 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)

Primary outcomes:
measure: Revised University of California Los Angeles Loneliness Scale - 8 (ULS-8)
timeFrame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
Other outcomes:
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
measure: Personal Health Questionnaire Depression Scale - 8 (PHQ-8)
timeFrame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)
Locations:
city: Austin
country: United States
facility: Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Michael J Telch, PhD
role: STUDY_DIRECTOR
affiliation: The University of Texas at Austin
name: Mikael Rubin, MA
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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.