Clinical trial NCT03070587: A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder
Official title: Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Compassion
Lead sponsor: Komazawa University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from Baseline in Self-Compassion Scale (SCS)
timeFrame: Baseline and 6 months
measure: Change from Baseline in Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline and 6 months
measure: Change from Baseline in compassion subscale of Differential Positive Emotions Scale
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Nishinomiya
country: Japan
facility: Kwansei Gakuin University
state: Hyogo
Study officials:
affiliation: Kwansei Gakuin University
name: Kohki Arimitsu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.