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Completed

NCT Number: NCT03070587

A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder

The purpose of this study is to develop and test a mindfulness and loving-kindness based intervention, Positive Affect Training (PAT), to enhance positive affect such as compassion, love, and gratitude and reduce symptoms of social anxiety disorder (SAD). PAT involves a combination of practicing mindfulness meditation and loving kindness meditation in groups. Although PAT has been shown to be effective for dysthymic disorder, one area that remains unclear is whether the PAT protocol for SAD can address the social anxiety symptoms in Japanese adults with SAD. The goal of the research is to test the initial feasibility and efficacy in increasing positive affect and decreasing negative affect in individuals recruited from the general community who are social anxious. If PAT is also effective for Japanese SAD patients, it could be more cost-effective and noninvasive option to address social anxiety disorder.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwansei Gakuin University

Nishinomiya, Hyōgo, 662-8501, Japan

About this study

Mindfulness based stress reduction (MBSR) and mindfulness based cognitive therapy (MBCT), which are based on Buddhist tradition, has been shown to be effective for many psychological disorders including anxiety disorders. Buddhist tradition, however, has many kinds of meditation which would be able to address psychological distress but MBSR and MBCT has not focused. Loving kindness meditation (LKM) is one of promising meditation to be effective for psychological disorders because it is designed to increase feelings of social connection and compassion for one's self and others, whose focus is different from mindfulness meditation. Since mindfulness meditation is designed to observe and accept current internal experiences as they are while maintaining a primary focus on the breath sensations, it would cultivate less compassion than LKM would. Because patients with SAD tend to be self-critical, cultivating compassion for self and others with LKM would be more effective to reduce symptoms of SAD than MBSR and MBCT. In support of the view that KM increases positive mood and a sense of connection and positivity towards others, previous studies with non-clinical samples, schizophrenia, dysthymia, and PTSD had decreased the mental illness. The intervention protocol that the investigators plan to use was developed by Dr. Kearney and Dr. Hofmann. The PAT protocol has been shown to generate positive, and attenuating negative affect in patients with PTSD and mood disorder. The investigators aim to test the initial efficacy of PAT in individuals with SAD. The investigators hypothesize the intervention would show significant improvement in subjects' self-reported ratings of negative and positive affect and the brain asymmetry. Dr. Hofmann, a prominent researcher and clinical psychologist who is the foremost expert in LKM will serve as a collaborator. Dr. Kaiya, a Japanese CBT therapist for anxiety disorders will serve as an outside consultant for the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20 years or older.
  • Positive response to the recruitment question: "Have you been feeling anxious or distressed in social situations?"
  • Meets DSM-5 diagnostic criteria for Social Anxiety Disorder based on the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
  • Social Anxiety Disorder is the primary diagnosis.
  • Liebowitz Social Anxiety Scale (LSAS) total score of 30 or higher.

Exclusion criteria

  • Current risk of self-harm or suicide, assessed by clinical interview and the suicide item of the Beck Depression Inventory-II (BDI-II).
  • Current or past psychiatric disorders that may impose a safety risk, such as bipolar disorder, schizophrenia spectrum disorders, or other psychotic disorders, as assessed by the SCID-5.
  • Current psychiatric or psychological treatment for any psychological disorder at the time of assessment.
  • Initiation of psychiatric or psychological treatment during the study; such participants will be monitored and may be excluded from sensitivity analyses.

Treatment and study plan

Positive Affect Training for SAD

Behavioral

The PAT-S protocol will teach the participants the basics of mindfulness and how to be aware of their physical sensation, thoughts, and emotion at present moment by a nonjudgmental way in breathing, standing, or eating. After two mindfulness sessions, lovingkindness meditation (LKM) will be introduced. The participants will be taught to identify and focus the positive feelings such as gratitude, love, kindness, peacefulness, or friendliness when they wish their benefactor and beloved ones who they feel grateful or respectful, and transfer these feelings first to themselves, then to a neutral individual, to people whom they dislike, and finally to all living beings.

Primary outcomes

  1. Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)

    Time frame: Baseline, 12 weeks, and 6 months

    The LSAS assesses fear/anxiety and avoidance across social interaction and performance situations. Higher scores indicate greater social anxiety severity.

Secondary outcomes

  1. Change from Baseline in Self-Compassion Scale (SCS)

    Time frame: Baseline, 12 weeks, and 6 months

    The SCS assesses self-compassion, including self-kindness, common humanity, and mindfulness. Higher scores indicate greater self-compassion.

  2. Change from Baseline in Positive and Negative Affect Scale (PANAS)

    Time frame: Baseline, 12 weeks, and 6 months

    The PANAS assesses positive affect and negative affect using 20 items rated on a 5-point scale. Higher scores indicate higher levels of positive or negative affect.

  3. Change from Baseline in the Dispositional Positive Emotion Scales (DPES)

    Time frame: Baseline, 12 weeks, and 6 months

    The DPES assesses dispositional positive emotions. Higher scores indicate greater dispositional positive emotions.

Sponsors and collaborators

Lead sponsor

Komazawa University

Other

Registry information

Official study title

Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 3, 2017
Registry last updated
Aug 28, 2026

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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