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

Primary Purpose

Social Anxiety Disorder, Compassion

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Positive Affect Training for SAD
Sponsored by
Komazawa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kwansei Gakuin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Positive Affect Training for SAD

Wait list Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
A self-report measure that assesses symptoms of distress experienced when socializing with others.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 28, 2017
Last Updated
March 7, 2023
Sponsor
Komazawa University
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1. Study Identification

Unique Protocol Identification Number
NCT03070587
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Komazawa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Affect Training for SAD
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list Control
Arm Type
No Intervention
Arm Description
These participants will not be given an intervention until after they have completed the study.
Intervention Type
Behavioral
Intervention Name(s)
Positive Affect Training for SAD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
Description
A self-report measure that assesses symptoms of distress experienced when socializing with others.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Self-Compassion Scale (SCS)
Description
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.
Time Frame
Baseline and 6 months
Title
Change from Baseline in Positive and Negative Affect Scale (PANAS)
Description
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.
Time Frame
Baseline and 6 months
Title
Change from Baseline in compassion subscale of Differential Positive Emotions Scale
Description
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.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kohki Arimitsu, Ph.D.
Organizational Affiliation
Kwansei Gakuin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwansei Gakuin University
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
662-8501
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26136807
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.
Results Reference
background
PubMed Identifier
21840289
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.
Results Reference
background
PubMed Identifier
26362245
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.
Results Reference
background
Links:
URL
https://clinical-affective-science.org/LKM.html
Description
The detailed information web-site

Learn more about this trial

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

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