NCT03070587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3.5 years

First QC Date

February 28, 2017

Last Update Submit

August 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)

    The LSAS assesses fear/anxiety and avoidance across social interaction and performance situations. Higher scores indicate greater social anxiety severity.

    Baseline, 12 weeks, and 6 months

Secondary Outcomes (3)

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

    Baseline, 12 weeks, and 6 months

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

    Baseline, 12 weeks, and 6 months

  • Change from Baseline in the Dispositional Positive Emotion Scales (DPES)

    Baseline, 12 weeks, and 6 months

Study Arms (2)

Positive Affect Training for SAD

EXPERIMENTAL

Participants randomized to the intervention arm will receive Positive Affect Training, a 12-week face-to-face group loving-kindness meditation program. The groups will meet once a week for 12 successive weeks, and each session will be approximately 60 minutes long. Each group will include approximately 4-6 participants and will be led by two trained facilitators/therapists. Participants will also be asked to complete approximately 30 minutes of daily home practice using recorded guided meditations and informal practice assignments.

Behavioral: Positive Affect Training for SAD

Wait-list Control

NO INTERVENTION

Participants randomized to the waitlist control arm will receive no study intervention during the 12-week waiting period. After completing the post-waitlist assessment, they will be offered the same 12-week face-to-face group loving-kindness meditation program as the intervention arm.

Interventions

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

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 years or older.
  • Positive response to the recruitment question: "Have you been feeling anxious or distressed in social situations?"
  • Meets DSM-5 diagnostic criteria for Social Anxiety Disorder based on the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
  • Social Anxiety Disorder is the primary diagnosis.
  • Liebowitz Social Anxiety Scale (LSAS) total score of 30 or higher.

You may not qualify if:

  • Current risk of self-harm or suicide, assessed by clinical interview and the suicide item of the Beck Depression Inventory-II (BDI-II).
  • Current or past psychiatric disorders that may impose a safety risk, such as bipolar disorder, schizophrenia spectrum disorders, or other psychotic disorders, as assessed by the SCID-5.
  • Current psychiatric or psychological treatment for any psychological disorder at the time of assessment.
  • Initiation of psychiatric or psychological treatment during the study; such participants will be monitored and may be excluded from sensitivity analyses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 26136807BACKGROUND
  • 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: 21840289BACKGROUND
  • 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: 26362245BACKGROUND

Related Links

MeSH Terms

Conditions

Phobia, Social

Interventions

Sagittal Abdominal Diameter

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological 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

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations