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Online Mindfulness-Based Intervention for ADHD (iMBI)

Primary Purpose

Attention-deficit Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Online Mindfulness-based Intervention
Online Introductory Psychology Program
Sponsored by
Universiti Tunku Abdul Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-deficit Hyperactivity Disorder focused on measuring Mindfulness, Online intervention, Malaysia

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universiti Tunku Abdul Rahman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Online Mindfulness-based Intervention

Online Introductory Psychology Program

Arm Description

iMBI will be delivered to participants in 8 online sessions, approximately 2 hours per session.

An online introductory psychology courses will be delivered to participants in 8 online sessions, approximately 2 hours per session.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2019
Last Updated
August 19, 2020
Sponsor
Universiti Tunku Abdul Rahman
Collaborators
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04229251
Brief Title
Online Mindfulness-Based Intervention for ADHD
Acronym
iMBI
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman
Collaborators
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit Hyperactivity Disorder
Keywords
Mindfulness, Online intervention, Malaysia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online Mindfulness-based Intervention
Arm Type
Experimental
Arm Description
iMBI will be delivered to participants in 8 online sessions, approximately 2 hours per session.
Arm Title
Online Introductory Psychology Program
Arm Type
Sham Comparator
Arm Description
An online introductory psychology courses will be delivered to participants in 8 online sessions, approximately 2 hours per session.
Intervention Type
Behavioral
Intervention Name(s)
Online Mindfulness-based Intervention
Other Intervention Name(s)
iMBI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Introductory Psychology Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from pretest Inattention scores at posttest.
Description
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.
Time Frame
8 weeks
Title
Change from pretest Inattention scores at 1-month follow-up.
Description
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.
Time Frame
12 weeks
Title
Change from baseline Inattention scores at 3-month follow-up
Description
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.
Time Frame
20 weeks
Title
Change from pretest Hyperactivity-Impulsivity scores at posttest.
Description
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.
Time Frame
8 weeks
Title
Change from pretest Hyperactivity-Impulsivity scores at 1-month follow-up.
Description
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.
Time Frame
12 weeks
Title
Change from pretest Hyperactivity-Impulsivity scores at 3-month follow-up.
Description
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.
Time Frame
20 weeks
Title
Change from pretest Executive Function Deficits scores at posttest.
Description
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.
Time Frame
8 weeks
Title
Change from pretest Executive Function Deficits scores at 1-month follow-up.
Description
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.
Time Frame
12 weeks
Title
Change from pretest Executive Function Deficits scores at 3-month follow-up.
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Shuen Pheh, MClinPsych
Organizational Affiliation
Universiti Tunku Abdul Rahman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Tunku Abdul Rahman
City
Kampar
State/Province
Perak
ZIP/Postal Code
31900
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33573341
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.
Results Reference
derived

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Online Mindfulness-Based Intervention for ADHD

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