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

Study Overview
=================
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.

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

Conditions
-----------------
Loneliness

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Alone (MO) Intervention
* Behavioral: Mindfulness + Compassion Intervention (MC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Trauma as a primary concern Significant depression with depression as a primary concern Severe mental illness (e.g. bipolar, schizophrenia, borderline personality disorder)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness + Compassion (MC) Intervention<br>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)<br>* Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.<br>|
| Active Comparator: Mindfulness Alone (MO) Intervention<br>Subjects assigned to this condition will participate in an hour-long, one-session telehealth intervention teaching mindfulness skills alone. | Behavioral: Mindfulness Alone (MO) Intervention<br>* Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.<br>|
| Placebo Comparator: Waitlist Control (WL)<br>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<br>* Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.<br>Behavioral: Mindfulness + Compassion Intervention (MC)<br>* Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Loneliness, Mindfulness, Telehealth, COVID-19