NCT06876220

Brief Summary

The current study aims to investigate the effectiveness of the 8-week Mindfulness-Based Cognitive Therapy for Life (MBCT-L) on the use of anchoring and distraction as emotion care/regulation strategies. It is hypothesized that anchoring and distraction are related but different processes, which could be evidenced by fMRI. The investigators further hypothesized that mindfulness training could lead to functional changes in the brain, which could also be evidenced by fMRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

November 26, 2023

Last Update Submit

July 20, 2025

Conditions

Keywords

mindfulnessemotion regulationemotion caredistractionanchoring

Outcome Measures

Primary Outcomes (7)

  • Brain activation during the emotion care/regulation task

    BOLD signal contrast when the participants performing an emotion counting Stroop task.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline)

  • Reaction time during the emotion care/regulation task

    Reaction time of the correct response in the emotion counting Stroop task.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline)

  • Accuracy during the emotion care/regulation task

    Accuracy of the emotion counting Stroop task.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline)

  • Mindfulness

    The mean score of Cognitive and Affective Mindfulness Scale-Revised (CAMS-R, Feldman, Hayes, Kumar, Greeson, \& Laurenceau, 2007) is a self-report 5-point Likert scale measuring individual differences in mindfulness that includes 12 items. The mean score ranged from 1 to 5. A higher score means a higher level of mindfulness, i.e. an expected outcome from an effective mindfulness intervention.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline), Follow-up (22-24 weeks after baseline)

  • Psychological well-being

    The mean score of Psychological Well-being Scale (PWBS; Ryff et al., 1995) includes 18 items measuring 6 aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Participants used a 5-point Likert scale, ranging from 1 = highly disagree to 5 = highly agree, to rate the 18 statements. The mean score ranged from 1 to 5. A higher score means a higher level of psychological well-being, i.e. an expected outcome from an effective mindfulness intervention.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline), Follow-up (22-24 weeks after baseline)

  • Use of distraction as a emotion care/regulation strategy

    The mean scores of five items of the self-developed scale to assess the use of distraction and its connection to attentional deployment with a pilot test. Participants used a 5-point Likert scale, ranging from 1 = never to 5 = always, to rate the five statements. The mean score ranged from 1 to 5. A higher score indicates a greater tendency to employ distraction as an emotion regulation strategy. It's important to note that the score only reflects the habitual usage of this strategy and does not imply a better or worse outcome.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline), Follow-up (22-24 weeks after baseline)

  • Use of anchoring as a emotion care/regulation strategy

    The mean score of five items of the self-developed scale to assess the use of anchoring with a pilot test. Participants used a 5-point Likert scale, ranging from 1 = never to 5 = always, to rate the five statements. The mean score ranged from 1 to 5. A higher score indicates a greater tendency to employ distraction as an emotion regulation strategy. It's important to note that the score only reflects the habitual usage of this strategy and does not imply a better or worse outcome.

    Baseline (2 weeks before the intervention), Post-intervention (14-16 weeks after baseline), Follow-up (22-24 weeks after baseline)

Study Arms (2)

intervention group

EXPERIMENTAL

Participants will receive an 8-week mindfulness-based group intervention, namely Mindfulness-based Cognitive Therapy for Life (MBCT-L).

Behavioral: Mindfulness-based Cognitive Therapy for Life (MBCT-L)

waitlist controlled group

NO INTERVENTION

Participants in the wait-list control group will receive the same intervention, two months after the experimental group completed the intervention.

Interventions

MBCT-L is an 8-week group intervention where participants are guided to practice mindfulness and cognitive exercise. The course covers themes such as anchoring, acceptance, and decentering. The course will be provided by mindfulness teachers who have completed the training offered by Oxford Mindfulness Foundation (OMF). Throughout the eight weeks, the course guides the participants through various themes such as anchoring, acceptance, and decentering. The sessions involve guided mindfulness practices, reflection, discussion, inquiry, and weekly home practice. The language of instruction is Cantonese.

intervention group

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right-handed
  • Currently registered in post-graduated program with professional counselling training

You may not qualify if:

  • History of neurological or other disorders affecting the brain (such as encephalitis, epilepsy, birth defects, or polio)
  • Have experienced a concussion, head or brain trauma, seizures, loss of consciousness
  • Have been injured in the eye by a metallic foreign body.
  • Have been injured by metallic foreign body (e.g. bullet, shrapnel)
  • History of sickle cell anemia/kidney disease/diabetes, asthma, or allergies
  • Long-term use of medication is required
  • Currently pregnant or breast feeding.
  • Had the following conditions or implants in their body:
  • Surgical clips
  • Cardiac pacemaker
  • Neurostimulator/internal electrodes
  • Insulin pump
  • Internal shunt
  • Metal screen / suture
  • Cochlear implants
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jockey Club "Peace and Awareness" Mindfulness Culture in Schools Initiative, Faculty of Social Sciences, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Shui-fong Lam, PhD

    The University of Hong Kong

    STUDY DIRECTOR
  • Gloria HY Wong

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-armed, waitlist randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 26, 2023

First Posted

March 14, 2025

Study Start

September 1, 2023

Primary Completion

January 21, 2025

Study Completion

February 13, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations