Online Mindfulness-Based Intervention for ADHD (iMBI)

August 19, 2020 updated by: Pheh Kai Shuen, Universiti Tunku Abdul Rahman

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Perak
      • Kampar, Perak, Malaysia, 31900
        • Universiti Tunku Abdul Rahman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Mindfulness-based Intervention
iMBI will be delivered to participants in 8 online sessions, approximately 2 hours per session.
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.
Other Names:
  • iMBI
Sham Comparator: Online Introductory Psychology Program
An online introductory psychology courses will be delivered to participants in 8 online sessions, approximately 2 hours per session.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from pretest Inattention scores at posttest.
Time Frame: 8 weeks
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
Change from pretest Inattention scores at 1-month follow-up.
Time Frame: 12 weeks
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
Change from baseline Inattention scores at 3-month follow-up
Time Frame: 20 weeks
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
Change from pretest Hyperactivity-Impulsivity scores at posttest.
Time Frame: 8 weeks
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
Change from pretest Hyperactivity-Impulsivity scores at 1-month follow-up.
Time Frame: 12 weeks
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
Change from pretest Hyperactivity-Impulsivity scores at 3-month follow-up.
Time Frame: 20 weeks
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
Change from pretest Executive Function Deficits scores at posttest.
Time Frame: 8 weeks
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
Change from pretest Executive Function Deficits scores at 1-month follow-up.
Time Frame: 12 weeks
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
Change from pretest Executive Function Deficits scores at 3-month follow-up.
Time Frame: 20 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Tunku Abdul Rahman

Collaborators

Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U/SERC/93/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All outcome measures data may be shared OSF Platform after the publications.

IPD Sharing Time Frame

Data will be made available after December 2022.

IPD Sharing Access Criteria

Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. The study protocol, statistical analysis plan, and informed consent forms are available on ClinicalTrials.gov.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Attention-deficit Hyperactivity Disorder

Clinical Trials on Online Mindfulness-based Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe