- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070587
A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder
Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hyogo
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Nishinomiya, Hyogo, Japan, 662-8501
- Kwansei Gakuin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Must be at least 20 years of age Responds positively to the question on the recruitment material (flyer and posting): "Have you been feeling anxious or distressed in social situations?" Must be diagnosed with Social Anxiety Disorders using the DSM-5 criteria Must have SAD as the primary diagnosis according to DSM-5 criteria Must have a negative affect scale score of the LSAS of at least 30 (a cutoff point which SAD is unlikely)
Exclusion Criteria:
Participants who are at risk of harming themselves will be excluded from participating in the study. Suicidality will be assessed after obtaining consent during the screening visit. In addition, the Beck Depression Inventory will be examined for self-reported suidicality. If a participant is found to have suicidal ideation (i.e., exceed a score of 2 on the suicide item of BDI-II), the principal investigator will be contacted immediately and appropriate follow-up care will be provided by referring the participant to the emergency room.
Participants will be assessed through a screening interview using the Structured Clinical Interview for DSM-5 for disorders that could impose a safety risk for the participants or others (e.g., bipolar disorder, schizophrenia, etc). Subjects who endorse "yes" responses to the screening items will be excluded.
Participants who are receiving any psychiatric or psychological treatment for any psychological disorders at the time of the assessment will be excluded from the study. Participants who initiate such treatments while being enrolled in the study will be closely monitored. These participants will be allowed to remain in the study, but will later be excluded from the data analyses. They are allowed to remain in the study for ethical reasons.
Study Plan
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
The intervention will be conducted in groups with 68 participants and 2 facilitators/therapists per group.
The groups will meet once a week for 12 successive weeks and each session will be approximately 60 minutes long.
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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
These participants will not be given an intervention until after they have completed the study.
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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 and 6 months
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A self-report measure that assesses symptoms of distress experienced when socializing with others.
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Baseline 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 and 6 months
|
Participants rated a 26-item test using 5-point scale that ranges from "almost never" (1) to "almost always" (5).
Items are averaged, yielding a range from 1 to 5.
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Baseline and 6 months
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Change from Baseline in Positive and Negative Affect Scale (PANAS)
Time Frame: Baseline and 6 months
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Participants in the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).
The total range is from 1 to 100.
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Baseline and 6 months
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Change from Baseline in compassion subscale of Differential Positive Emotions Scale
Time Frame: Baseline and 6 months
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Participants in the DPES are required to respond to a 38-item test using 7-point scale that ranges from "strongly disagree" (1) to "strongly agree" (7).
Items are averaged, yielding a range from 1 to 7.
|
Baseline and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kohki Arimitsu, Ph.D., Kwansei Gakuin University
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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