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

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

Study Description

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

• 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

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

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

• 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

Contacts

Contact: Michael J Telch, PhD; 512-560-4100; telch@austin.utexas.edu

Contact: Mikael Rubin, MA; 646-685-4681; mikaelrubin@utexas.edu

Locations

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

• 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

Additional Information:

Website for the Laboratory for the Study of Anxiety Disorders 

Publications:

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.

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.

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.

Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. Epub 2006 Jun 19. Review.

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.

• 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
• 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/

• 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