A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder

NCT03070587 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder; Compassion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline in Self-Compassion Scale (SCS)

  Baseline and 6 months

• Change from Baseline in Positive and Negative Affect Scale (PANAS)

  Baseline and 6 months

• Change from Baseline in compassion subscale of Differential Positive Emotions Scale

  Baseline and 6 months

Study Arms (2)

Positive Affect Training for SAD

EXPERIMENTAL

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.

Behavioral: Positive Affect Training for SAD

Wait list Control

NO INTERVENTION

These participants will not be given an intervention until after they have completed the study.

Interventions

Positive Affect Training for SAD BEHAVIORAL

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.

Positive Affect Training for SAD

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Komazawa University: lead

Study Sites (1)

Kwansei Gakuin University

Nishinomiya, Hyōgo, 662-8501, Japan

Location

Related Publications (3)

• 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.

  PMID: 26136807 BACKGROUND

• 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.

  PMID: 21840289 BACKGROUND

• 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.

  PMID: 26362245 BACKGROUND

Related Links

• The detailed information web-site

MeSH Terms

Conditions

Phobia, Social

Interventions

Sagittal Abdominal Diameter

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Officials

• Kohki Arimitsu, Ph.D.

  Kwansei Gakuin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: December 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)