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Completed

NCT Number: NCT04414826

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

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.

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Key information

Conditions

Loneliness COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness Alone (MO) Intervention

Behavioral

Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.

Mindfulness + Compassion Intervention (MC)

Behavioral

Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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