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Comparing the Brief Mindfulness Programme of Introducing Mindfulness with HOME Practice Digital App (IMHome) to Standard Mindfulness-Based Cognitive Therapy (MBCT): A Non-inferiority Randomized Controlled Trial for Subthreshold Anxiety and Depression

Comparing the Brief Mindfulness Programme of Introducing Mindfulness with HOME Practice Digital App (IMHome) to Standard Mindfulness-Based Cognitive Therapy (MBCT): A Non-inferiority Randomized Controlled Trial for Subthreshold Anxiety and Depression

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099570
Enrollment
Unknown
Registered
2025-03-25
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subthreshold anxiety and/or depression

Interventions

Arm 1:Mindfulness Programme of Introducing Mindfulness with HOME Practice Digital App (IMHome)
Arm 2:Standard Mindfulness-Based Cognitive Therapy (MBCT)

Sponsors

School of Nursing, The Hong Kong Polytechnic University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: Adults aged 18 years or older. Subthreshold Anxiety and/or Depression: Presence of subthreshold anxiety (defined as a score of 5 to 14 on the 7-item Generalized Anxiety Disorder Scale, GAD-7) and/or subthreshold depression (defined as a score of 5 to 14 on the 9-item Patient Health Questionnaire depression scale, PHQ-9). A score of = 15 suggests moderately severe-to-severe symptoms requiring immediate clinical treatment. Cognitive Functioning: Normal cognitive functioning, enabling participants to understand the mindfulness training materials and complete home practice assignments each week.

Exclusion criteria

Exclusion criteria: Medical or Mental Health Conditions: Presence of any medical or mental health condition that would render the individual incapable of participating in the study or adhering to the intervention requirements. Language Barrier: Inability to understand Chinese, as the mindfulness programs will be conducted in Chinese. Prior Mindfulness Training: Previous participation in any formal mindfulness-based training or intervention, as this may confound the study results.

Design outcomes

Primary

MeasureTime frame
Depression;Anxiety;

Secondary

MeasureTime frame
Home mindfulness practice;FFMQ(the five facet mindfulness questionnaire);PSS(perceived stress scale);ISI(Insomnia Severity Index);EQ-5D-5L (quality of life);HCU(Health care utilisation);

Countries

China

Contacts

Public ContactDaisy Dexing Zhang

School of Nursing, The Hong Kong Polytechnic University

daisy.dx.zhang@polyu.edu.hk+852 2766 6546

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026