Online Mindfulness-Based Intervention for ADHD

NCT ID: NCT04229251

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Attention-deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online Mindfulness-based Intervention

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

Group Type EXPERIMENTAL

Online Mindfulness-based Intervention

Intervention Type BEHAVIORAL

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

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

Group Type SHAM_COMPARATOR

Online Introductory Psychology Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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iMBI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role collaborator

Universiti Tunku Abdul Rahman

OTHER

Sponsor Role lead

Responsible Party

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Pheh Kai Shuen

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai-Shuen Pheh, MClinPsych

Role: PRINCIPAL_INVESTIGATOR

Universiti Tunku Abdul Rahman

Locations

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Universiti Tunku Abdul Rahman

Kampar, Perak, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type DERIVED
PMID: 33573341 (View on PubMed)

Other Identifiers

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U/SERC/93/2019

Identifier Type: -

Identifier Source: org_study_id

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