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

NCT04414826 | Completed

• 1 other identifier: 2020-04-0088
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Keywords

Loneliness; Mindfulness; Telehealth; COVID-19

Outcome Measures

Primary Outcomes (1)

• Revised University of California Los Angeles Loneliness Scale - 8 (ULS-8)

  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 Outcomes (1)

• Perceived Stress Scale (PSS)

  Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

Other Outcomes (3)

• Generalized Anxiety Disorder - 7 (GAD-7)

  Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

• Personal Health Questionnaire Depression Scale - 8 (PHQ-8)

  Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

• Brunnsviken Brief Quality of Life Scale (BBQ)

  Baseline (Day 0), one-week follow-up (Day 14), two-week follow-up (Day 21)

Study Arms (3)

Mindfulness + Compassion (MC) Intervention

ACTIVE COMPARATOR

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)

Mindfulness Alone (MO) Intervention

ACTIVE COMPARATOR

Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching mindfulness skills alone.

Behavioral: Mindfulness Alone (MO) Intervention

Waitlist Control (WL)

PLACEBO COMPARATOR

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; Behavioral: Mindfulness + Compassion Intervention (MC)

Interventions

Mindfulness Alone (MO) Intervention BEHAVIORAL

Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.

Mindfulness Alone (MO) Intervention; Waitlist Control (WL)

Mindfulness + Compassion Intervention (MC) BEHAVIORAL

Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.

Mindfulness + Compassion (MC) Intervention; Waitlist Control (WL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Trauma as a primary concern
• Significant depression with depression as a primary concern
• Severe mental illness (e.g. bipolar, schizophrenia, borderline personality disorder)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Website for the Laboratory for the Study of Anxiety Disorders

MeSH Terms

Conditions

COVID-19

Interventions

Mindfulness; Methods

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Investigative Techniques

Study Officials

• Michael J Telch, PhD

  The University of Texas at Austin

  STUDY DIRECTOR

• Mikael Rubin, MA

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Participants will be randomized to one of three groups: (a) Mindfulness alone; (b) Mindfulness + Compassion; and (c) Wait-list control.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: May 25, 2020
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Access Criteria: Data will be made available on osf

Locations

US (1)