Social Anxiety DisorderNCT03070587
A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder
A study testing Positive Affect Training for SAD in people with Social Anxiety Disorder and Compassion, run by Komazawa University at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Social Anxiety Disorder, Compassion
- What is being tested?
- Positive Affect Training for SAD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2016to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety Disorder, Compassion
- Being tested
- Positive Affect Training for SAD
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect Training for SADBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect Training for SAD | Experimental | 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. Receives: Behavioral: Positive Affect Training for SAD |
| Wait-list Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, and 6 months
Secondary outcomes (3)
Change from Baseline in Self-Compassion Scale (SCS)
The SCS assesses self-compassion, including self-kindness, common humanity, and mindfulness. Higher scores indicate greater self-compassion.
Measured: Baseline, 12 weeks, and 6 months
Change from Baseline in Positive and Negative Affect Scale (PANAS)
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.
Measured: Baseline, 12 weeks, and 6 months
Change from Baseline in the Dispositional Positive Emotion Scales (DPES)
The DPES assesses dispositional positive emotions. Higher scores indicate greater dispositional positive emotions.
Measured: Baseline, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startDec 2016
- Primary completionJun 2020
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Komazawa University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kohki Arimitsu, Ph.D., Principal investigator, Kwansei Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070587
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2017
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26136807Hofmann 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.
PubMed 21840289Arimitsu 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.
PubMed 26362245
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03070587
- Acronym / sponsor ID
- 001
- Conditions
- Social Anxiety Disorder, Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Komazawa UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Training for SAD | Experimental | Behavioral: Positive Affect Training for SADParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Affect Training for SADThe 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. | Behavioural | Positive Affect Training for SAD |
Primary outcome
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.
3 secondary outcomes
Change from Baseline in Self-Compassion Scale (SCS)
Time frame: Baseline, 12 weeks, and 6 months
Change from Baseline in Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, 12 weeks, and 6 months
Change from Baseline in the Dispositional Positive Emotion Scales (DPES)
Time frame: Baseline, 12 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 26136807Hofmann 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.
- Background: PubMed 21840289Hofmann 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.
- Background: PubMed 26362245Arimitsu 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.
- The detailed information web-siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kohki Arimitsu, Ph.D. principal investigator
Kwansei Gakuin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Training for SAD in people with Social Anxiety Disorder and Compassion, run by Komazawa University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS) (time frame: Baseline, 12 weeks, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070587, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.