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

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414826
• Other study ID #: 2020-04-0088
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: May 2022
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Loneliness

Intervention

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

Locations

Country	Name	City	State
United States	Laboratory for the Study of Anxiety Disorders, University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Generalized Anxiety Disorder - 7 (GAD-7)	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)
Other	Personal Health Questionnaire Depression Scale - 8 (PHQ-8)	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)
Other	Brunnsviken Brief Quality of Life Scale (BBQ)	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)
Primary	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	Perceived Stress Scale (PSS)	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)

External Links

•   Website for the Laboratory for the Study of Anxiety Disorders