Clinical trial NCT04229251: Online Mindfulness-Based Intervention for ADHD
Official title: Efficacy of Online Mindfulness-Based Intervention on Emerging Malaysian Chinese Adults With Attention Deficit/Hyperactivity Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention-deficit Hyperactivity Disorder
Keywords: Mindfulness
Online intervention
Malaysia
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
Collaborators: name: Universiti Putra Malaysia
First posted: 2020-01-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacies of an online mindfulness-based intervention for emerging adults with ADHD in Malaysia. The investigators hypothesized that online mindfulness-based intervention may improve ADHD symptoms and executive functions of emerging adults with ADHD.

Detailed description: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder that often persist to adulthood. In Malaysia, the Chinese ethnic is having the highest prevalence rate of hyperactivity symptoms. Nevertheless, there are only limited evidence-based treatment options targeting the core symptoms of ADHD, as well as executive functions in adulthood. In addition, conventional psychotherapeutic approaches for adults with ADHD have found to be highly labor-intensive. Emerging adulthood is a distinct developmental stage of 18 - 29 years old, with unique challenges that rarely addressed in mental health system. Recently, mindfulness-based intervention appears to be a promising treatment for adults living with ADHD but it has not been evaluated among Malaysian emerging adults with ADHD. The investigators proposed a two-arm randomized controlled trial, comparing an eight-week online mindfulness-based intervention program with an online introductory psychology program. The outcomes include changes of inattention symptom, changes of hyperactivity-impulsivity symptom, and changes of executive functions from pretest to posttest, 1-month follow-up and 3-month follow-up. To investigators' best knowledge, this randomized controlled trial will be the first to test the efficacious of online mindfulness-based intervention for ADHD among emerging adults. It will provide evidence on the efficacious of online treatment for this often-overlooked population in the mental healthcare system.

Eligibility criteria: Inclusion Criteria:

* 18 to 29 years old.
* Diagnosis of ADHD.
* Completed at least six years of Chinese education.
* Participants taking psychotropic prescriptions will be allowed to participate, if they prescriptions were stable for at least 6 weeks prior to their participation in this study.

Exclusion Criteria:

* History or current presence of substance dependence, psychotic illness, bipolar disorder, personality disorders, conduct disorder, chronic suicidal, or self-injurious behaviour as reported in the Diagnostic Interview For Anxiety, Mood, Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND).
* Non-verbal intellectual ability of percentile ranks 25 or below.
* Received cognitive-behavioural therapy (CBT) for ADHD or any form of mindfulness-based intervention in the past 2 years.

Primary outcomes:
measure: Change from pretest Inattention scores at posttest.
timeFrame: 8 weeks
measure: Change from pretest Inattention scores at 1-month follow-up.
timeFrame: 12 weeks
measure: Change from baseline Inattention scores at 3-month follow-up
timeFrame: 20 weeks
measure: Change from pretest Hyperactivity-Impulsivity scores at posttest.
timeFrame: 8 weeks
measure: Change from pretest Hyperactivity-Impulsivity scores at 1-month follow-up.
timeFrame: 12 weeks
measure: Change from pretest Hyperactivity-Impulsivity scores at 3-month follow-up.
timeFrame: 20 weeks
measure: Change from pretest Executive Function Deficits scores at posttest.
timeFrame: 8 weeks
measure: Change from pretest Executive Function Deficits scores at 1-month follow-up.
timeFrame: 12 weeks
measure: Change from pretest Executive Function Deficits scores at 3-month follow-up.
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kampar
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Perak
Study officials:
affiliation: Universiti Tunku Abdul Rahman
name: Kai-Shuen Pheh, MClinPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pheh KS, Tan KA, Ibrahim N, Sidik SM. Effectiveness of Online Mindfulness-Based Intervention (iMBI) on Inattention, Hyperactivity-Impulsivity, and Executive Functioning in College Emerging Adults with Attention-Deficit/Hyperactivity Disorder: A Study Protocol. Int J Environ Res Public Health. 2021 Jan 30;18(3):1257. doi: 10.3390/ijerph18031257.