An interventional study of Mindfulness in Mental Health and Insomnia, sponsored by The University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
The goal of this single-arm pilot clinical trial is to evaluate whether a group-based mindfulness intervention can improve mental health and sleep among parents who are informal caregivers of children with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD). The main questions it aims to answer are:
Does participating in an 8-week mindfulness program reduce symptoms of stress, anxiety, depression, and insomnia in caregivers? Does participating in an 8-week mindfulness program improve mindfulness in caregivers? What are the caregivers' experiences in participating in the 8-week mindfulness program?
Participants will:
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's planned enrollment of 30 is below the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The group-based mindfulness programme will consist of 8 weekly sessions (\~90 min each, 12-18 participants per group). Each session includes a homework practice review, guided, structured mindfulness practices, and a discussion of experiences and learning.
Behavioral: Mindfulness
Refer to the arm description
Change in stress level
Stress was measured using the 14-item Perceived Stress Scale (PSS). Possible scores range from 0 to 56, with higher scores indicating a higher stress level.
Time frame: Baseline, end of treatment at 8 weeks
Change in depressive symptoms
Depressive symptoms were measured using the 9-item Patient Health Questionnaire (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating higher depression severity.
Time frame: Baseline, end of treatment at 8 weeks
Change in anxiety symptoms
Axniety symptoms were measured using the Generalized Anxiety Disorder 7-item (GAD-7). Possible scores range from 0 to 21, with higher scores indicating higher anxiety severity.
Time frame: Baseline, end of treatment at 8 weeks
Change in insomnia symptoms
Insomnia symptoms were measured using the Insomnia Severity Index (ISI). It consists of 7 items. Possible scores range from 0 to 28, with higher scores indicating higher insomnia severity.
Time frame: Baseline, end of treatment at 8 weeks
Change in mindfulness ability
Mindfulness ability was measured using the 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15). Possible scores range from 15 to 75, with higher scores indicating a higher mindfulness level.
Time frame: Baseline, end of treatment at 8 weeks
Attendance, practice, and overall impression
Attendance, practice, and overall impression were measured using a 9-question survey, with 3 questions on attendance, 2 on overall impression, and 4 on practice. In particular, there are 2 rating-scale items in the overall impression construct and 1 in the practice construct for the probability of future use of mindfulness practice. The scales range from 0 to 10, where higher scores indicate a better overall impression/greater probability for continued use of the practice.
Time frame: End of treatment at 8 weeks
Unpleasant experiences and harm
Unpleasant experiences and harm were assessed using a 10-question survey: 3 on unpleasant experiences, 2 on harm, and 5 on coping. In particular, one Likert scale was used to assess the perceived helpfulness item in the coping construct. The scale ranges from 1 to 5, where a higher score indicates greater helpfulness of the support.
Time frame: End of treatment at 8 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Hong Kong