NCT04229251

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 21, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

December 29, 2019

Last Update Submit

August 19, 2020

Conditions

Attention-deficit Hyperactivity Disorder

Keywords

MindfulnessOnline interventionMalaysia

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Online Mindfulness-based Intervention

EXPERIMENTAL

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

Behavioral: Online Mindfulness-based Intervention

Online Introductory Psychology Program

SHAM COMPARATOR

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

Behavioral: Online Introductory Psychology Program

Interventions

Online Mindfulness-based InterventionBEHAVIORAL

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.

Also known as: iMBI
Online Mindfulness-based Intervention
Online Introductory Psychology ProgramBEHAVIORAL

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.

Online Introductory Psychology Program

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Tunku Abdul Rahman

Kampar, Perak, 31900, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 33573341DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Kai-Shuen Pheh, MClinPsych

    Universiti Tunku Abdul Rahman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 18, 2020

Study Start

October 15, 2020

Primary Completion

June 30, 2021

Study Completion

December 30, 2021

Last Updated

August 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available after December 2022.
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.

Locations

MY(1)