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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 March 2023 |
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Main ID: |
NCT03070587 |
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Date of registration:
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28/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder
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Scientific title:
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Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03070587 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kohki Arimitsu, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kwansei Gakuin University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Social Anxiety Disorder
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Compassion
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Intervention(s)
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Behavioral: Positive Affect Training for SAD
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Primary Outcome(s)
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Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
[Time Frame: Baseline and 6 months]
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Secondary Outcome(s)
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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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Change from Baseline in Self-Compassion Scale (SCS)
[Time Frame: 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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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