Social Anxiety Disorder Clinical Trial
Official title:
Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder
NCT number | NCT03070587 |
Other study ID # | 001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | September 2022 |
Verified date | March 2023 |
Source | Komazawa University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | September 2022 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Japan | Kwansei Gakuin University | Nishinomiya | Hyogo |
Lead Sponsor | Collaborator |
---|---|
Komazawa University |
Japan,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS) | A self-report measure that assesses symptoms of distress experienced when socializing with others. | Baseline and 6 months | |
Secondary | Change from Baseline in Self-Compassion Scale (SCS) | 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. | Baseline and 6 months | |
Secondary | Change from Baseline in Positive and Negative Affect Scale (PANAS) | 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. | Baseline and 6 months | |
Secondary | Change from Baseline in compassion subscale of Differential Positive Emotions Scale | 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 |
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