Online Mindfulness-Based Intervention for ADHD

Attention-deficit Hyperactivity Disorder Clinical Trial

— iMBI  

Official title:

Efficacy of Online Mindfulness-Based Intervention on Emerging Malaysian Chinese Adults With Attention Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04229251
• Other study ID #: U/SERC/93/2019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2020
• Source: Universiti Tunku Abdul Rahman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 108
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Online Mindfulness-based Intervention
The iMBI starts with psychoeducation about ADHD and defining mindfulness. Participants were then encouraged to discuss their experience of living with ADHD via a series of guided questions. Upon orientated to the program, the participants will be introduced to various topics of mindfulness and ADHD, as well as a wide range of in-session online mindfulness exercises. Offline assignments that correspond to each week's theme will be assigned to participants at the end of each session. Downloadable audio tracks for offline practices will be provided to the participants. Participants are expected to spend around 15 to 30 minutes each day to complete the weekly iMBI assignment.
• Online Introductory Psychology Program
The online introductory psychology program is a mass online open course program, providing comprehensive overview about psychology as an academic discipline. Each week, participants will be presented with approximately 2-hours pre-recorded lecture. Offline assignments that correspond to each week's theme will be assigned to participants at the end of each session.Downloadable handouts for revision will be provided to the participants. Participants are encouraged to spend around 15 to 30 minutes each day to complete the weekly assignment.

Locations

Country	Name	City	State
Malaysia	Universiti Tunku Abdul Rahman	Kampar	Perak

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman	Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pretest Inattention scores at posttest.	The ADHD Self-Report Scale (Inattention Subscale) is used in monitoring treatment response of Adult ADHD. The Inattention subscale scores range from 0 to 36, where higher scores indicate more severe levels of inattention.	8 weeks
Primary	Change from pretest Inattention scores at 1-month follow-up.	The ADHD Self-Report Scale (Inattention Subscale) is used in monitoring treatment response of Adult ADHD. The Inattention subscale scores range from 0 to 36, where higher scores indicate more severe levels of inattention.	12 weeks
Primary	Change from baseline Inattention scores at 3-month follow-up	The ADHD Self-Report Scale (Inattention Subscale) is used in monitoring treatment response of Adult ADHD. The Inattention subscale scores range from 0 to 36, where higher scores indicate more severe levels of inattention.	20 weeks
Primary	Change from pretest Hyperactivity-Impulsivity scores at posttest.	The ADHD Self-Report Scale (Hyperactivity-Impulsivity Subscale) is used in monitoring treatment response of Adult ADHD. The Hyperactivity-Impulsivity subscale scores range from 0 to 36, where higher scores indicate more severe levels of hyperactivity-impulsivity.	8 weeks
Primary	Change from pretest Hyperactivity-Impulsivity scores at 1-month follow-up.	The ADHD Self-Report Scale (Hyperactivity-Impulsivity Subscale) is used in monitoring treatment response of Adult ADHD. The Hyperactivity-Impulsivity subscale scores range from 0 to 36, where higher scores indicate more severe levels of hyperactivity-impulsivity.	12 weeks
Primary	Change from pretest Hyperactivity-Impulsivity scores at 3-month follow-up.	The ADHD Self-Report Scale (Hyperactivity-Impulsivity Subscale) is used in monitoring treatment response of Adult ADHD. The Hyperactivity-Impulsivity subscale scores range from 0 to 36, where higher scores indicate more severe levels of hyperactivity-impulsivity.	20 weeks
Primary	Change from pretest Executive Function Deficits scores at posttest.	The Adult Executive Functioning Inventory (ADEXI) is used in monitoring treatment response of Adult ADHD. The Executive Function Deficits subscale scores range from 14 to 70, where higher scores indicate more severe levels of executive function deficits.	8 weeks
Primary	Change from pretest Executive Function Deficits scores at 1-month follow-up.	The Adult Executive Functioning Inventory (ADEXI) is used in monitoring treatment response of Adult ADHD. The Executive Function Deficits subscale scores range from 14 to 70, where higher scores indicate more severe levels of executive function deficits.	12 weeks
Primary	Change from pretest Executive Function Deficits scores at 3-month follow-up.	The Adult Executive Functioning Inventory (ADEXI) is used in monitoring treatment response of Adult ADHD. The Executive Function Deficits subscale scores range from 14 to 70, where higher scores indicate more severe levels of executive function deficits.	20 weeks