NCT06595849

Brief Summary

This is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes.

Trial Health

63
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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
3mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress87%
Oct 2024Aug 2026

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

September 11, 2024

Last Update Submit

September 11, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mindfulness (Five Facet Mindfulness Questionnaire - 20)

    The 20-item Five Facet Mindfulness Questionnaire - 20 (FFMQ-20) will be used to measure mindfulness. Possible score range is 20 to 100, where higher scores indicate higher mindfulness.

    4-week; 8-week

  • Equanimity (Equanimity Scale)

    The 16-item Equanimity Scale (ES-16) will be used to measure equanimity. Possible score range is 16 to 80, where higher scores indicate higher equanimity.

    4-week; 8-week

  • Self-compassion (Sussex-Oxford Compassion for the Self Scale)

    The 20-item Sussex-Oxford Compassion for the Self Scale (SOCS-S) will be used to measure self-compassion. Possible score range is 20 to 100, where higher scores indicate higher self-compassion.

    4-week; 8-week

Secondary Outcomes (4)

  • Depression (Patient Health Questionnaire - 9)

    4-week; 8-week

  • Anxiety (Generalized Anxiety Disorder - 7)

    4-week; 8-week

  • Stress (Perceived Stress Scale - 10)

    4-week; 8-week

  • Wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale)

    4-week; 8-week

Study Arms (1)

Intervention

EXPERIMENTAL

This is a single-arm trial, where all participants will be assigned to the intervention group.

Behavioral: 4-week feeling tone intervention program

Interventions

Participants will take part in a 4-week mindfulness of feeling tone intervention program taught by a registered mindfulness teacher, who is also a registered clinical psychologist. The intervention program includes 4 sessions, with each session lasting for about 2 hours. The program is taught in Cantonese, in a group setting, live online (via Zoom). Participants will practice meditation practices during the session, explore themes of the week, review and explore their meditation experiences. They will also practice meditation practices daily for at least 30 minutes at home, with meditation audio recordings provided by the teacher.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 or above
  • speak and understand Cantonese as well as written Chinese to a level where the participant can fully take part in the course without the need for translation support
  • have means to access online teleconferencing meeting software (e.g., Zoom), online surveys, online intervention materials, and Short Message Service (SMS) or WhatsApp messenger

You may not qualify if:

  • moderately severe or severe depressive or anxiety symptoms
  • diagnosed with bipolar disorder or bipolar affective disorder (type I or type II) or ever experienced a manic/hypomanic episode
  • diagnosed with schizophrenia/ psychosis or ever experienced a psychotic episode
  • diagnosed with dementia/ neurocognitive disorders/ neurological disorders
  • diagnosed with intellectual disability
  • diagnosed with other neurodevelopmental disorders
  • experience of a traumatic event that is currently affecting the potential participants
  • recent bereavement, major loss, or stressful life events
  • suicidal
  • alcohol or drug abuse
  • currently experiencing other mental or physical health condition, or life condition that might affect potential participants' participation in the course
  • prior experience of taking part in the feeling tone intervention as a course participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Hoi Chun Lok, MSocSc(CP)

    Department of Psychology, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoi Chun Lok, MSocSc(CP)

CONTACT

Amanda Kingsze Cheung, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations