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

The University of Texas System (UT)

Status: Completed

Conditions: Loneliness

Treatments: Behavioral: Mindfulness + Compassion Intervention (MC); Behavioral: Mindfulness Alone (MO) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04414826

2020-04-0088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups, including a placebo group

Mindfulness + Compassion (MC) Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness + Compassion Intervention (MC)

Mindfulness Alone (MO) Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness Alone (MO) Intervention

Waitlist Control (WL)

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness Alone (MO) Intervention

Behavioral: Mindfulness + Compassion Intervention (MC)