A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder
Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 28, 2026
August 1, 2026
3.5 years
February 28, 2017
August 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
The LSAS assesses fear/anxiety and avoidance across social interaction and performance situations. Higher scores indicate greater social anxiety severity.
Baseline, 12 weeks, and 6 months
Secondary Outcomes (3)
Change from Baseline in Self-Compassion Scale (SCS)
Baseline, 12 weeks, and 6 months
Change from Baseline in Positive and Negative Affect Scale (PANAS)
Baseline, 12 weeks, and 6 months
Change from Baseline in the Dispositional Positive Emotion Scales (DPES)
Baseline, 12 weeks, and 6 months
Study Arms (2)
Positive Affect Training for SAD
EXPERIMENTALParticipants 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.
Wait-list Control
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kwansei Gakuin University
Nishinomiya, Hyōgo, 662-8501, Japan
Related Publications (3)
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.
PMID: 26136807BACKGROUNDHofmann 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.
PMID: 21840289BACKGROUNDArimitsu 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.
PMID: 26362245BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kohki Arimitsu, Ph.D.
Kwansei Gakuin University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 3, 2017
Study Start
December 1, 2016
Primary Completion
June 1, 2020
Study Completion
September 1, 2022
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share