Internet-based Mindfulness-based Training (iMBT) for People With Depression

NCT05410132 | Completed

• 1 other identifier: SBRE-21-0158
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The research goals of this randomized controlled trial are to determine the feasibility and the mechanism of change of iMBT that has been developed using the Acceptance Checklist for Clinical Effectiveness Pilot Trials. The primary research question is as follows: What is the effectiveness of the iMBT in relation to improvements on depressive symptoms among people with clinical depression, relative to a usual care control after the intervention and in 3-month follow-up? Secondary questions include the following: Which facet(s) of mindfulness (i.e., observe, describe, act with awareness, non-react and non-judgement) improved during the intervention? How does the growth trajectory of different facets of mindfulness relate to the improvement of well-being and reduction of ill-being? The investigators hypothesize that: H1 Participants in iMBT group will have greater reduction in depressive symptoms and increase in all facets of mindfulness and mental well-being, than the usual care group at post-intervention, and 3-month follow-up. H2 Using latent growth analysis, the intraindividual growth trajectory of the monitor and acceptance facets of mindfulness would mediate the effect of iMBT on the intraindividual changes in depressive symptoms. H3 Using multi-group analysis, in accord with Acceptance and Monitor theory, the relationship between the growth trajectory of monitor facets of mindfulness and the growth trajectory of depressive symptoms will be moderated by the level of acceptance. People with greater acceptance of inner experience will benefit more from the change of monitor facets of mindfulness in iMBT.

Conditions

Mindfulness; Depression

Keywords

mental well-being; depression; Internet-based Mindfulness-based Training; online

Outcome Measures

Primary Outcomes (5)

• Depression

  Patient Health Questionnaire (PHQ9) (Kroenke, Spitzer, \& Williams, 2001). It is a 9-item measure to access the severity of depression. PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively (range: 0-27).

  at baseline

• Depression

  Patient Health Questionnaire (PHQ9) (Kroenke, Spitzer, \& Williams, 2001). It is a 9-item measure to access the severity of depression. PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively (range: 0-27).

  2nd week

• Depression

  Patient Health Questionnaire (PHQ9) (Kroenke, Spitzer, \& Williams, 2001). It is a 9-item measure to access the severity of depression. PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively (range: 0-27).

  4th week

• Depression

  Patient Health Questionnaire (PHQ9) (Kroenke, Spitzer, \& Williams, 2001). It is a 9-item measure to access the severity of depression. PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively (range: 0-27).

  6th week

• Depression

  Patient Health Questionnaire (PHQ9) (Kroenke, Spitzer, \& Williams, 2001). It is a 9-item measure to access the severity of depression. PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively (range: 0-27).

  18th week

Secondary Outcomes (8)

• Mindfulness

  at baseline, 2nd, 4th, 6th, and 18th week

• Mental Well-being

  at baseline, 2nd, 4th, 6th, and 18th week

• Credibility and Expectancy

  at baseline, 2nd, 4th, 6th, and 18th week

• Difficulties in Emotional Regulation Scale

  at baseline, 2nd, 4th, 6th, and 18th week

• Non-attachment

  at baseline, 2nd, 4th, 6th, and 18th week

Study Arms (2)

Internet-based mindfulness-based training group (iMBT)

EXPERIMENTAL

Participants in the iMBT group will be expected to complete an Internet-based mindfulness-based training delivered over a 6-week period via an internet e-learning mental health platform. They will be assessed at four different time points: (1) before intervention (T0), (2) 2,4 weeks since the commencement of group (T1,2), (3) 6 weeks after (i.e., when the intervention ends) (T3), (4) at 3-month follow-up(T4).

Other: Internet-delivered Mindfulness Based Training (iMBT)

Treatment-as-usual control group (TAU)

NO INTERVENTION

The TAU group will be advised to seek assistance from their usual healthcare provider when needed. They will be offered access to the Internet-based mindfulness-based course content after the study has ended.

Interventions

Internet-delivered Mindfulness Based Training (iMBT) OTHER

The iMBT developed for this study will be adapted from our team's previous study and the manual of mindfulness based cognitive therapy. The program is designed to be brief in nature, for example, participants will be asked to practice meditations for 15 minutes a day instead of the original 45 minutes a day, and each module is shortened to approximately 1 hour instead of the original 2.5 hours. This iMBT is comprised of six weekly modules on education about mindfulness, guidance on using mindfulness skills to manage symptoms, guided meditations (e.g., mindful breathing, mindful eating, mindful walking, body scan, acceptance, choiceless awareness and disengaging from thoughts exercise), and guidance on using informal mindfulness skills in day-to-day life. Readings, audio and graphics are included to explain the concept of mindfulness and overcome common difficulties associated with mindfulness practice.

Internet-based mindfulness-based training group (iMBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 years old or above
• Have access to computer and mobile phone (since this is an internet-based therapy)
• Score \>9 on PHQ9
• Have the ability to read and type Chinese

You may not qualify if:

• Self-reported presence of psychosis or bipolar disorder, post-traumatic stress disorder, drug or alcohol dependence, current use of antipsychotic medications
• Self-reported frequent suicidal ideation (more than half of the days in the past two weeks)
• Completion of an online mental health program/research for depression in the past 3 months

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychology

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 8, 2022
• Study Start: March 24, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

HK (1)