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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001200471
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/09/2025
Date registered
Help: Date registered
31/10/2025
Date last updated
Help: Date last updated
3/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
31/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Internet Videoconferencing-Delivered Cognitive Behavioural Therapy for Adult Attention-Deficit/Hyperactivity Disorder: A Feasibility Study
Scientific title
Internet Videoconferencing-Delivered Cognitive Behavioural Therapy for Adult Attention-Deficit/Hyperactivity Disorder: A Feasibility Study
Additional trial identifiers [1] 315362 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
attention deficit/hyperactivity disorder 338846 0
Condition category
Condition code
Mental Health 335135 335135 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment consists of individually delivered internet-videoconferencing delivered CBT (vCBT; 10x weekly 50-minute sessions). The vCBT will be manualised and will cover: psychoeducation about ADHD and goal setting; organisational skills; reducing distractibility; psychoeducation on the CBT model of ADHD; cognitive restructuring to develop adaptive thinking; and relapse prevention. The vCBT treatment will be provided by a provisional psychologist or psychologist with 1-5 years of experience. Adherence to the treatment will be monitored by the clinician each week.
Intervention code [1] 331964 0
Behaviour
Intervention code [2] 331965 0
Treatment: Other
Description of the comparator or control
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342771 0
ADHD symptom severity
Timepoint [1] 342771 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [1] 452058 0
Anxiety
Timepoint [1] 452058 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [2] 452059 0
Depression
Timepoint [2] 452059 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [3] 452060 0
Quality of life
Timepoint [3] 452060 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [4] 452061 0
Self-esteem
Timepoint [4] 452061 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [5] 452062 0
Acceptability
Timepoint [5] 452062 0
Immediately post-treatment completion (week 11)
Secondary outcome [6] 452063 0
Acceptability
Timepoint [6] 452063 0
Immediately post-treatment completion (week 11)
Secondary outcome [7] 452066 0
Feasibility
Timepoint [7] 452066 0
Follow-up (week 23 post-enrolment)
Secondary outcome [8] 452067 0
Feasibility
Timepoint [8] 452067 0
Follow-up (week 23 post-enrolment)
Secondary outcome [9] 453471 0
Efficacy - clinically significant change
Timepoint [9] 453471 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [10] 453472 0
Efficacy - diagnostic change
Timepoint [10] 453472 0
Pre-treatment, immediately post-treatment completion (week 11) and follow-up (week 23 post-treatment)
Secondary outcome [11] 453473 0
Efficacy - deterioration
Timepoint [11] 453473 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [12] 453475 0
ADHD symptom severity
Timepoint [12] 453475 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [13] 453476 0
ADHD symptom severity
Timepoint [13] 453476 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [14] 453478 0
Change in ADHD symptom severity - clinician
Timepoint [14] 453478 0
Mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [15] 453479 0
Change in ADHD symptom severity - self report
Timepoint [15] 453479 0
Mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)
Secondary outcome [16] 453861 0
Efficacy - clinically significant change
Timepoint [16] 453861 0
Pre-treatment, mid-treatment (week 5), immediately post-treatment completion (week 11) and follow-up (week 23 post-enrolment)

Eligibility
Key inclusion criteria
1) Presently residing in Australia;
2) Aged 18 years or over;
3) Fluent in English;
4) Meets criteria for ADHD and the disorder is of at least “moderate severity” (defined as a score of 4 on the DIAMOND module severity measure);
5) Medication-free or on a stable dose (6 weeks) of psychotropic medication or stimulant medication; and
6) Not presently receiving regular psychological services for their ADHD-related challenges (defined as sessions at least once a week with a qualified mental health professional, including an ADHD coach); and
7) Have access to a private location to complete the treatment for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1) Suicide risk as assessed by item 9 of the Patient Health Questionnaire-9 item (PHQ-9; a score of 2 or above) at baseline, or the Colombia Suicide Severity Rating Scale (C-SSRS), or a response of ‘yes’ to item 1–3 of the risk questionnaire, or via clinician judgement during the diagnostic interview;
2) Engagement in non-suicidal self-injury in the past 12 months;
3) Daily use of alcohol or illicit drugs (meaning illegal drugs, pharmaceutical drugs used outside their prescribed or intended use, and other substances inappropriately used);
4) The presence of a schizophrenia spectrum disorder, bipolar disorder, substance use disorder, or anorexia nervosa as assessed by the DIAMOND semi-structured clinical interview;
5) Any significant cognitive/intellectual impairment as assessed during the diagnostic interview;
6) A medical condition that may interfere with treatment;
7) No access to a computer with a camera and stable internet on a regular basis;
8) Is not willing to engage in treatment on a regular basis using internet-videoconferencing software; or
9) Does not meet the threshold on the Adult ADHD Self-Report Screening Scale for DSM-5 (ASRS-5) and the WURS-25 (Wender Utah Rating Scale-25).

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To meet the study’s aim (i.e., to understand if the treatment is efficacious for reducing ADHD-related challenges), the following analyses will be conducted. The main analyses looking at treatment outcomes from the trial will be carried out using conservative intention-to-treat principles and using mixed linear model analyses to handle missing data. Mixed models are a robust statistical approach for analysing longitudinal clinical trial data and these analyses will employ an appropriate covariance structure and maximum likelihood estimation, which provides unbiased estimates in the case of missing data, under the assumption that data is missing at random. These analyses account for the effect of missing data, thus additional participant recruitment to account for drop-out rates is not warranted. Symptom change on the primary and secondary outcome measures will be examined from pre-treatment to post-treatment and pre-treatment to follow up. Within group effect sizes (Cohen’s d) will also be calculated.
Using this dataset, other appropriate analyses arising from secondary papers will also be conducted. Participants have been informed in the PICF that other secondary data analyses will be conducted on the data that they provide during their participation in the research trial. Results will be benchmarked with previous estimates of CBT in the general population and for the CBT for ADHD protocol.
To understand the treatment’s efficacy, clinically significant change will be measured using three methods:
1) Diagnostic change will be assessed from pre- to post-treatment and at follow-up using the DIAMOND structured interview;
2) Treatment response (Safren et al., 2010; Solanto et al., 2010; Steele et al., 2006). Any increase in symptoms by 30% or more will be defined as deterioration in this trial.
3) Clinically significant change will be defined as 30% reduction from baseline ASRS-18 score and scoring below 4 on the CGI severity scale.
To meet the study’s aim to quantitatively understand if the treatment is feasible and acceptable for participants with ADHD, proportions will be calculated for participant drop-out, questionnaire completion, and descriptive statistics will be used to analyse the acceptability questionnaire.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/01/2026
Actual
10/02/2026
Date of last participant enrolment
Anticipated
12/10/2026
Actual
Date of last data collection
Anticipated
22/03/2027
Actual
Sample size
Target
35
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319947 0
University
Name [1] 319947 0
University of Technology Sydney
Country [1] 319947 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 322478 0
None
Name [1] 322478 0
None
Address [1] 322478 0
Country [1] 322478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318483 0
UTS Human Research Ethics Committee
Ethics committee address [1] 318483 0
Ethics committee country [1] 318483 0
Australia
Date submitted for ethics approval [1] 318483 0
16/07/2025
Approval date [1] 318483 0
17/09/2025
Ethics approval number [1] 318483 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144346 0
Prof Bethany Wootton
Address 144346 0
Discipline of Clinical Psychology. Graduate School of Health.University of Technology Sydney PO Box 123. Broadway. NSW 2007
Country 144346 0
Australia
Phone 144346 0
+61 2 9514 3942
Fax 144346 0
Email 144346 0
[email protected]
Contact person for public queries
Name 144347 0
Bethany Wootton
Address 144347 0
Discipline of Clinical Psychology. Graduate School of Health.University of Technology Sydney PO Box 123. Broadway. NSW 2007
Country 144347 0
Australia
Phone 144347 0
+61 2 9514 3942
Fax 144347 0
Email 144347 0
[email protected]
Contact person for scientific queries
Name 144348 0
Bethany Wootton
Address 144348 0
Discipline of Clinical Psychology. Graduate School of Health.University of Technology Sydney PO Box 123. Broadway. NSW 2007
Country 144348 0
Australia
Phone 144348 0
+61 2 9514 3942
Fax 144348 0
Email 144348 0
[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:
• Any academic who has expertise in the field of Adult Attention-Deficit/Hyperactivity Disorder

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
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:
3 years after the end of the study

To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• From the Chief Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Rivqa Rafael vCBT for ADHD protocol V1.1 - clean.docx
Informed consent form    Rivqa Rafael vCBT for ADHD PICF V1.1 - clean.docx


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.