Insomnia, Mental Health
Conditions
Brief summary
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: * Attend weekly group-based mindfulness sessions for 1.5 hours over eight weeks. * Complete assessments before starting the program (baseline) and immediately after the final session. * Participate in a qualitative feedback interview after the final session.
Interventions
BEHAVIORALMindfulness
Refer to the arm description
Sponsors
The University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Chinese aged at least 18 years old; 2. Written informed consent of participation in the study is given by the participant 3. Willing to comply with the study protocol 4. having a child with neurodevelopment disorder (e.g., ASD, ADHD)
Exclusion criteria
1. having been enrolled in any other clinical trial or investigational product within one month at the entry of the study, or having extensive experience in mindfulness practice 2. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) 3. Currently receiving any structured psychotherapy 4. With a hearing or speech deficit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stress level | Baseline, end of treatment at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms | Baseline, end of treatment at 8 weeks | 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. |
| Change in anxiety symptoms | Baseline, end of treatment at 8 weeks | 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. |
| Change in insomnia symptoms | Baseline, end of treatment at 8 weeks | 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. |
| Change in mindfulness ability | Baseline, end of treatment at 8 weeks | 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. |
Contacts
CONTACTShirley X Li, PhD, DClinPsy
Outcome results
None listed