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Trial registered on ANZCTR

Registration number

ACTRN12625000380493

Ethics application status

Approved

Date submitted

7/04/2025

Date registered

29/04/2025

Date last updated

29/04/2025

Date data sharing statement initially provided

29/04/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Pilot Trial of Mindfulness-Integrated Cognitive Behavioural Therapy for Adults with Attention-Deficit Hyperactivity Disorder and Depression and/or Anxiety

Scientific title

Mindfulness-integrated Cognitive Behavioural Therapy (MiCBT) for Treating Depression, Anxiety, Emotional Dysregulation among Adults with Attention Deficit Hyperactivity Disorder (ADHD): A Mixed-Method Pilot Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

attention-deficit hyperactivity disorder

depression

anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Name / Overview.
This study aims to measure feasibility, acceptability, and potential efficacy for mindfulness-integrated cognitive behavioural therapy (MiCBT) for treating symptoms of depression, anxiety, emotion dysregulation, and ADHD behavioural symptoms in adults with diagnosed ADHD. MiCBT is a transdiagnostic therapy which blends meditation-based mindfulness training with elements of cognitive behavioural therapy. More information on this therapy can be found at mindfulness.net.au or through the Treatment Manual (Cayman et al., 2018).

What.
This trial will offer a slightly modified version of the traditional MiCBT therapy, using the same materials as published in the treatment manual (Cayoun et al., 2018). In discussion with the founder of the therapy, Dr. Bruno Cayoun, we have received permission modify delivery for adults with ADHD in these ways: 1) we are extending the duration from 10 weeks to 12, so that we can move slower at times if needed and offer more support; 2) we will offer 1:1 support via phone consultation mid-way though delivery to add further support; 3) we will allow the daily meditation durations to be slightly less (e.g., when a guided meditation runs for 13 minutes and asks participants to continue on in silence, these participants will be told that any additional un-guided time is entirely optional).

The therapy consists of at-home meditations with audio guides to be practised twice daily as far as possible. It also includes weekly group sessions held face-to-face to help introduce, practise, support, and troubleshoot the meditation practice, as well as to introduce and support participants through integrated components from cognitive behavioural therapy. Sessions will generally follow this agenda: 1) to review the previous week's meditation practice, sharing experiences and responding to questions or concerns that arise; 2) introducing the next week's theoretical component (e.g., what is mindfulness) and the rationale for the next meditation practice; 3) guiding participants through the new meditation practice; 4) addressing any questions / concerns and supporting them to be able to follow that week's meditation practice.

In the first week, participants use progressive muscle relaxation as a way to relax their bodies and experiment with how to make time for meditation, so that by week 2, when the begin mindfulness meditations, they feel more confident about their habits. Meditations then progress with: Week 2, mindfulness of breath; Week 3, introduction to body scanning; Week 4, body scanning with objective descriptions of sensations; Week 5, symmetrical scanning; Week 6, additional practice of symmetrical scanning and individual support offered; Week 7, partial sweeping; Week 8, sweeping en mass; Week 9, transversal scanning; Week 10, additional practice of transversal scanning; Week 11, sweeping in depth; Week 12, loving kindness.

Who.
All therapy sessions, individual consultation, and administration of measures will be conducted by Denise Goggin, a registered clinical psychologist registrar with training and professional experience delivering a range of therapies including CBT and MiCBT, as well as experiencing delivering therapy and assessments to adults with ADHD, depression, and anxiety.

All treatment delivery and assessment administration will be performed with appropriate supervision in place for any incident to review and suggest procedures. A supervisory group will meet monthly throughout the trial, and within 24-48 hours of any incident to review and suggest procedures to ensure safety and well-being of all participants.

How and Where.
Delivery of the 12 group sessions will be done weekly and face-to-face, with a duration of 2.5 hours per session. Materials for the therapy will be provided as printed handouts, as well as through free access to the MiCBT app. The researchers will have no ability to access any participant data on the app. The use of this tool is to also provide the materials, including the audio guides for meditations, in one place for ease of use and engagement.

All administration of assessments will be done through a trained clinician with appropriate instructions. This may be the treating clinician, though will be a registered and trained psychologist who is not the treating clinician for the post-treatment qualitative interview so as to avoid biased responses.

When and How Much.
There will be 12 consecutive weeks of therapy provided. Each week will have 1 face-to-face session lasting 2.5 hours, including short breaks. Participants are asked to practice guided meditations twice per day with each meditation lasting around 20 minutes.

Participants will be asked to return for follow-up assessments three months following treatment. This means the trial will last 6 months (3 months therapy and 3 months for the follow-up assessment).

Tailoring.
This treatment is not going to be personalised as it aims to measure feasibility, acceptability, and potential efficacy for the treatment as adapted for use with an adult ADHD population.

Modifications.
All materials will be from the traditional MiCBT treatment manual, including all handouts and audio guides. However, the traditional MiCBT program has been adapted for this delivery by extending the number of weeks, offering 1:1 support mid-way through delivery , and allowing for some meditation times to be reduced.

How Well.
Adherence to group sessions will be tracked by recording attendance. Adherence to daily meditation practice will be tracked through written practice logs recorded by the participants. For those participants using the MiCBT app, their practice will be automatically tracked by the app, and they will be asked to transfer this to a written record for the researchers. For those who choose not to use the app, but the emailed link to the audio guide, they will record their meditations on the written log on a daily basis.

Meditation logs will track frequency, duration, and perceived engagement with the meditation for each practice.

Participants who do not attend a group session or stop practising meditations at home will be consulted about their desire to continue and offered support if they would like to re-engage. Participants are informed at the start through both verbal and written form that they are free to stop at any time, without consequence, and without needing to provide a reason. They are also informed that if they stop meditations, they will be considered as having dropped out from the trial, though they can continue to attend the sessions if beneficial. Any participants who develop physical or mental health concerns that make participation in the group unrealistic will be counselled by the treating clinician, including a throrough risk assessment with relevant supports and referrals provided.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

ADHD behavioural symptoms - this will be a composite outcome, not each symptom independently

Timepoint [1]

Baseline (week 0), post-treatment (week 12-13), and 3-month follow-up (week 24-25). The provision of 2 weeks for administration of post-treatment and follow-up assessments is for logistical reasons, in case participants have difficulty scheduling the assessment.

Primary outcome [2]

Depression

Timepoint [2]

Primary outcome [3]

Anxiety

Timepoint [3]

Secondary outcome [1]

Executive function

Timepoint [1]

Baseline (week 0) and post-treatment (week 12-13).

Secondary outcome [2]

Composite score of attentional regulation and impulsivity

Timepoint [2]

Baseline (week 0) and post-treatment (week 12-13).

Secondary outcome [3]

Equanimity (or non-reactivity)

Timepoint [3]

Baseline (week 0) and post-treatment (week 12-13).

Secondary outcome [4]

Mindfulness

Timepoint [4]

Baseline (week 0) and post-treatment (weeks 12-13)

Secondary outcome [5]

Anxiety (also a primary measure)

Timepoint [5]

Same as other primary measures: baseline, post-treatment, 3-month follow-up

Secondary outcome [6]

Emotion regulation - also a primary measure

Timepoint [6]

Same as other primary measures: baseline, post-treatment, 3-month follow-up

Eligibility

Key inclusion criteria

Inclusion criteria are: aged 18 and over; ability to join face-to-face weekly sessions for the duration of the trial; fluency in English; official diagnosis of ADHD; presence of ADHD symptoms; current symptoms of depression and/or anxiety at a moderate or higher level as determined by results on the DASS-21 during the screening process; stabilised psychological medication within one month prior to trial start, if medicated; and commitment to the trial program and daily meditations.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusionary criteria are: current suicidality or suicidal behaviours within the 12 months prior; daily use of non-prescribed or illicit substances over the prior 6 months; anticipated changes to any psychological medication plan; official diagnoses of autism, Tourette Syndrome, psychosis, mania, traumatic brain injury, intellectual disability, or any personality disorder; inability to attend sessions and commit to daily practice; experience learning formal meditation practice within the 12 months prior to trial; current meditation practices; engagement in other psychological treatment during period of trial; and lack of any inclusion criteria above. Informed consent will be obtained by the researcher for all participants prior to their commencement.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample Size.
The study aims to recruit 34 participants. An attrition rate of 20% is expected based on recent findings of average attrition rates in clinical trials of mindfulness-based interventions (Lam et al., 2022), which would result in a total of 27 participants, allowing for detection of moderate effect sizes (a = .05) of t-test analysis based on G*Power calculations. Following the recommended group size for MiCBT, these participants will be separated randomly into three or four groups, all receiving the same adapted manualized MiCBT treatment.

Analysis Plan.
Quantitative analysis will be conducted to measure the efficacy of MiCBT in terms of reducing symptoms of depression, anxiety, emotion dysregulation, and ADHD symptoms, as well as increasing executive function, interoceptive awareness, equanimity, and mindfulness. Within-group differences from baseline to post-treatment, and baseline to follow-up, will be analysed with paired t-tests. Within-group differences will also be analysed as a repeated-measures ANOVA, comparing baseline, post-treatment, and follow-up results. Cohen’s d effect sizes at both post-treatment and follow-up will be determined by differences in standard deviations from baseline. These analyses will include participants regardless of their trial completion, following an intent-to-treat approach. To analyse the efficacy of MiCBT in terms of reducing ADHD behavioural, depression, anxiety, and emotion dysregulation symptoms at post-treatment and follow-up, a reduction of symptoms by 30% or greater will be used as an indicator of clinical levels of change, as measured by the CAARS 2. This is in line with previous studies in this area (Janssen et al., 2020; Mitchell et al., 2017).

To assess the feasibility and acceptability of MiCBT, quantitative analysis will consider proportions achieved in recruitment success, participant retention, adherence to the program requirements, and completion of outcome measures. To qualitatively analyse this research question, data collected from the experience interview will be thematically analysed in NVivo software using Framework Analysis (Ritchie & Spencer, 1994).

Following the Framework Analysis process, the first stage will be familiarization by listening to, or reading transcribed versions of each interview at least twice. Second, the thematic framework will be constructed through coding based on key themes and sub-themes where relevant. All codes will be discussed and cross-checked within the research team before the next stage. Third, data will be indexed so that each response is assigned at least one theme and given a numerical value corresponding to the code to aid the next stage. Fourth, the themes will be charted so that participant responses are organised by theme in a table or other visual representation. Fifth, patterns will be highlighted from the charted information, interpretations made about the data overall, and key quotes highlighted to represent the main conclusions. Throughout the process, researchers will work collaboratively to cross-check themes, coding, and interpretations. Although written in a linear way, these five stages may be revisited at different points during the research process.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

14/04/2025

Date of last participant enrolment

Anticipated

15/09/2025

Actual

Date of last data collection

Anticipated

30/03/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Technology Sydney

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Technology Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UTS Human Research Ethics Committee

Ethics committee address [1]

https://www.uts.edu.au/research-and-teaching/research/our-approach/ethics-and-integrity/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/09/2024

Approval date [1]

25/11/2024

Ethics approval number [1]

Summary

Brief summary

This pilot trial aims to measure feasibility, accessibility, and efficacy of mindfulness-integrated cognitive behavioural therapy (MiCBT) for adults with ADHD who are experiencing depression and/ or depression. The therapy will be delivered in weekly group sessions and participants will be asked to practice seated meditations twice per day. The guided meditations aim to increase participants' ability to mindfully observe and not react to physical sensations that arise from thoughts and emotions, and then to apply this skill to stressful situations in their own lives, and in line with their own therapy goals.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Denise Goggin

Address

UTS Psychology Clinic, Level 10 Building 20, 100 Broadway, Ultimo, 2007 NSW

Country

Australia

Phone

+61 0404 458 299

Fax

[email protected]

Contact person for public queries

Name

Denise Goggin

Address

UTS Psychology Clinic, Level 10 Building 20, 100 Broadway, Ultimo, 2007 NSW

Country

Australia

Phone

+61 0404 458 299

Fax

[email protected]

Contact person for scientific queries

Name

Denise Goggin

Address

UTS Psychology Clinic, Level 10 Building 20, 100 Broadway, Ultimo, 2007 NSW

Country

Australia

Phone

+61 0404 458 299

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: The data steward has been nominated as Dr. Alice Shires (a supervisor working on this trial and the current Director of the UTS Psychology Clinic). Either she or the primary researcher, Denise Goggin, may receive requests for participant data through their email or through contact with the UTS Psychology Clinic. The researchers can be reached at [email protected] and [email protected].

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Attachment
24607	Ethical approval	Original Ethics Approval	Ethics Approval_MiCBT Trial.pdf
24608	Ethical approval	Ethics Amendment Approval	Ethics Amendment Approval Letter.pdf
24609	Informed consent form	Participant Information Sheet	PIS MiCBT Trial.pdf
24610	Statistical analysis plan	Research Data Management Plan	Research Data Management Plan_v1.2.pdf
24611	Study protocol		MiCBT 2.1.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically