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

Not Applicable

Completed

• Conditions: Loneliness
• Interventions: Behavioral: Mindfulness Alone (MO) Intervention; Behavioral: Mindfulness + Compassion Intervention (MC)

• Registration Number: NCT04414826
• Lead Sponsor: University of Texas at Austin

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.

Study Timeline

• Study Start: 2020-05-25
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Primary Completion: 2021-11-26
• Study Completion: 2021-11-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Alone (MO) Intervention	Mindfulness Alone (MO) Intervention	Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching mindfulness skills alone.
Waitlist Control (WL)	Mindfulness + Compassion Intervention (MC)	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.
Mindfulness + Compassion (MC) Intervention	Mindfulness + Compassion Intervention (MC)	Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching both mindfulness and compassion skills.
Waitlist Control (WL)	Mindfulness Alone (MO) Intervention	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.

Primary Outcome Measures

Name	Time	Method
Revised University of California Los Angeles Loneliness Scale - 8 (ULS-8)	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

Name	Time	Method
Perceived Stress Scale (PSS)	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.

Trial Locations

Locations (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin; 🇺🇸 Austin, Texas, United States