Acceptability, Feasibility, and Effectiveness of a Four-Week Feeling Tone Mindfulness Course

Not Applicable

Not yet recruiting

• Conditions: Mindfulness; Depression; Anxiety; Stress; Wellbeing; Self-compassion
• Interventions: Behavioral: 4-week feeling tone intervention program

• Registration Number: NCT06595849
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

The four-week feeling tone mindfulness course is an adapted version of a mindfulness intervention program recently developed by Professor Mark Williams and colleagues. This study aims to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes (e.g., depression, anxiety, stress, wellbeing) in a Hong Kong population.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-16
• Last Update Posted: 2024-09-16
• Study Start: 2024-10
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	4-week feeling tone intervention program	This is a single-arm trial, where all participants will be assigned to the intervention group.

Primary Outcome Measures

Name	Time	Method
Mindfulness (Five Facet Mindfulness Questionnaire - 20)	4-week; 8-week	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.
Equanimity (Equanimity Scale)	4-week; 8-week	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.
Self-compassion (Sussex-Oxford Compassion for the Self Scale)	4-week; 8-week	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.

Secondary Outcome Measures

Name	Time	Method
Depression (Patient Health Questionnaire - 9)	4-week; 8-week	The nine-item Patient Health Questionnaire - 9 (PHQ-9) will be used to measure depression. Possible score range is 0 to 27, where higher scores mean more severe depression.
Anxiety (Generalized Anxiety Disorder - 7)	4-week; 8-week	The seven-item Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Possible score range is 0 to 21, where higher scores indicate more severe anxiety.
Stress (Perceived Stress Scale - 10)	4-week; 8-week	The 10-item Perceived Stress Scale - 10 (PSS) will be used to measure stress. Possible score range is 0 to 40, where higher scores indicate higher perceived stress.
Wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale)	4-week; 8-week	The seven-item Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) will be used to measure wellbeing. Possible score range is 0 to 35, where higher scores mean higher mental wellbeing.

Trial Locations

Locations (1)

Department of Psychology, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong