- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070587
A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder
August 26, 2026 updated by: Komazawa University
Effect of Mindfulness and Loving Kindness Meditation on Symptoms of 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hyōgo
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Nishinomiya, Hyōgo, Japan, 662-8501
- Kwansei Gakuin University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Positive Affect Training for SAD
Participants randomized to the intervention arm will receive Positive Affect Training, a 12-week face-to-face group loving-kindness meditation program.
The groups will meet once a week for 12 successive weeks, and each session will be approximately 60 minutes long.
Each group will include approximately 4-6 participants and will be led by two trained facilitators/therapists. Participants will also be asked to complete approximately 30 minutes of daily home practice using recorded guided meditations and informal practice assignments.
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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.
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No Intervention: Wait-list Control
Participants randomized to the waitlist control arm will receive no study intervention during the 12-week waiting period.
After completing the post-waitlist assessment, they will be offered the same 12-week face-to-face group loving-kindness meditation program as the intervention arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
Time Frame: Baseline, 12 weeks, and 6 months
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The LSAS assesses fear/anxiety and avoidance across social interaction and performance situations.
Higher scores indicate greater social anxiety severity.
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Baseline, 12 weeks, and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Self-Compassion Scale (SCS)
Time Frame: Baseline, 12 weeks, and 6 months
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The SCS assesses self-compassion, including self-kindness, common humanity, and mindfulness.
Higher scores indicate greater self-compassion.
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Baseline, 12 weeks, and 6 months
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Change from Baseline in Positive and Negative Affect Scale (PANAS)
Time Frame: Baseline, 12 weeks, and 6 months
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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.
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Baseline, 12 weeks, and 6 months
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Change from Baseline in the Dispositional Positive Emotion Scales (DPES)
Time Frame: Baseline, 12 weeks, and 6 months
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The DPES assesses dispositional positive emotions.
Higher scores indicate greater dispositional positive emotions.
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Baseline, 12 weeks, and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kohki Arimitsu, Ph.D., Kwansei Gakuin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hofmann SG, Grossman P, Hinton DE. Loving-kindness and compassion meditation: potential for psychological interventions. Clin Psychol Rev. 2011 Nov;31(7):1126-32. doi: 10.1016/j.cpr.2011.07.003. Epub 2011 Jul 26.
- Hofmann SG, Petrocchi N, Steinberg J, Lin M, Arimitsu K, Kind S, Mendes A, Stangier U. Loving-Kindness Meditation to Target Affect in Mood Disorders: A Proof-of-Concept Study. Evid Based Complement Alternat Med. 2015;2015:269126. doi: 10.1155/2015/269126. Epub 2015 Jun 1.
- Arimitsu K, Hofmann SG. Effects of compassionate thinking on negative emotions. Cogn Emot. 2017 Jan;31(1):160-167. doi: 10.1080/02699931.2015.1078292. Epub 2015 Sep 11.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
February 28, 2017
First Posted (Actual)
March 3, 2017
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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