Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000284369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
10/02/2026
Date registered
Help: Date registered
5/03/2026
Date last updated
Help: Date last updated
1/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
5/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Integrative Attention and Somatic Processing Therapy (IASP) for women with an adult diagnosis of Attention Deficit Hyperactivity Disorder (ADHD): A pilot study.
Scientific title
Integrative Attention and Somatic Processing Therapy (IASP) for women with an adult diagnosis of ADHD: A pilot study investigating the impact of a novel therapeutic approach on psychosocial burden of ADHD, psychological distress, mentalisation, self-compassion and hope.
Additional trial identifiers [1] 316488 0
Nil known.
Universal Trial Number (UTN)
U1111-1335-4948
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Attention Deficit Hyperactivity Disorder 340617 0
Condition category
Condition code
Mental Health 336812 336812 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This counselling intervention draws from a number of well-established therapeutic theories and techniques which have been synthesised and customised to meet the challenges associated with a late diagnosis of ADHD in women. Although not intended to be strictly manualised, the intervention will include the following processes:
Establishing Trusting Relationship
1. Establish a sense of epistemic trust between therapist and client via provision of:
a. deep listening
b. non-verbal and somatic feedback
c. a non-judgemental stance
Attending to interoceptive awareness
2. Attend to the patient’s cues around interoceptive awareness and their ability to connect with their sense of self by paying particular focus to:
a. the minute particulars of both the patient’s story and their somatic cues
b. their diffuse awareness (inattention)
c. experiences of shame
d. experiences of guilt associated with ADHD symptoms
Focused Mentalization
3. Explore and process patient’s mentalization especially of:
a. confused inner experiences
b. social cognitions
c. paradoxical experiences
Support the development of self-compassion
4. Aid patient in understanding and appreciating self-compassion by:
a. providing psychoeducation
b. reviewing and reframing identity injuries
c. developing capacity for acceptance of challenging experiences and their subjective meaning
d. practising self-compassion
Activation of hope and strategic action
5. Support the patient’s discovery of hope for positive change through:
a. reimagined identity
b. continued development of robust personal agency
c. the development of identity aligned goals
d. exploration of goal pathways
The intervention will be delivered by Dr Denis O'Hara and Dr Kate Witteveen, both of whom have over 20 years' counselling experience and are the developers of the approach. The intervention will be delivered in 8 x 60-minute face-to-face counselling sessions, delivered over a course of approximately 16 weeks (one session every two weeks) at the UQ With You Counselling Clinic, located at 17 Upland Rd, St Lucia.
Video recordings of the sessions will be assessed with the fidelity checklist developed specifically for this study. Fidelity checking will be conducted by two independent assessors, Dr Jim Schirmer and Mr Michael Ellwood. Dr Schirmer and Mr Ellwood are both experienced counsellors with over 15 years of experience and have been trained in the approach.
The intervention and control groups will be matched by age to ensure both groups include a similar age range. This is to ensure any treatment effects are not influenced by age.
Intervention code [1] 333157 0
Treatment: Other
Description of the comparator or control
A waitlist control group, matched for gender (i.e., female) and diagnosis (i.e., ADHD) will complete the pre- and post-test questionnaires. They will not receive any treatment throughout the course of this study.
Control group
Active

Outcomes
Primary outcome [1] 344338 0
Psychosocial burden of ADHD
Timepoint [1] 344338 0
Baseline and post-intervention (approximately 16 weeks later).
Primary outcome [2] 344339 0
Psychological distress
Timepoint [2] 344339 0
Baseline and post-intervention (approximately 16 weeks later)
Primary outcome [3] 344455 0
Quality of life
Timepoint [3] 344455 0
Baseline and post-intervention (approximately 16 weeks later)
Secondary outcome [1] 457561 0
Mentalisation
Timepoint [1] 457561 0
Baseline and post-intervention (approximately 16 weeks later)
Secondary outcome [2] 457562 0
Self-compassion
Timepoint [2] 457562 0
Baseline and post-intervention (approximately 16 weeks later)
Secondary outcome [3] 457563 0
Hope
Timepoint [3] 457563 0
Baseline and post-intervention (approximately 16 weeks later)
Secondary outcome [4] 457974 0
Subjective perception of the benefits of the intervention
Timepoint [4] 457974 0
After each therapy session

Eligibility
Key inclusion criteria
Women and individuals assigned female at birth (AFAB) who:
• Are over 18 years old;
• Received a diagnosis of ADHD in adulthood (after the age of 18 years);
• Are fluent in English; and
• Are seeking therapy for challenges associated with receiving a late diagnosis of ADHD.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
• Men, assigned male at birth (AMAB) and individuals under the age of 18 years;
• Individuals who self-identify as having ADHD but have not been formally diagnosed;
• Individuals who are not sufficiently fluent in English to meaningfully engage in therapy delivered in English;
• Individuals experiencing extreme psychological distress or significant psychiatric conditions which would interfere with their capacity to meaningfully engage in therapy, such as active psychosis or dissociative identity disorder.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will utilise a triangulation mixed-method approach with a small sample (5 participants per group). This sample size was selected due to the preliminary nature of this study, which is a pilot test of a newly developed therapeutic approach. Quantitative data collected at time 1 and time 2 will be analysed via t-tests and is intended to provide additional insights to the qualitative data collected via the Helpful Aspects of Therapy (HAT) which is completed after each session. In addition, qualitative analysis of the video transcripts will inform the fidelity checks conducted by the independent assessors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
15/01/2027
Actual
Date of last data collection
Anticipated
30/05/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 321099 0
University
Name [1] 321099 0
The University of Queensland
Country [1] 321099 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 323903 0
None
Name [1] 323903 0
Address [1] 323903 0
Country [1] 323903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319636 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 319636 0
Ethics committee country [1] 319636 0
Australia
Date submitted for ethics approval [1] 319636 0
10/02/2026
Approval date [1] 319636 0
23/04/2026
Ethics approval number [1] 319636 0
2026/HE010129

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

Contacts
Principal investigator
Name 147938 0
Dr Kate Witteveen
Address 147938 0
The University of Queensland, St Lucia, Brisbane, Qld 4072
Country 147938 0
Australia
Phone 147938 0
+61 0409230698
Fax 147938 0
Email 147938 0
[email protected]
Contact person for public queries
Name 147939 0
Kate Witteveen
Address 147939 0
The University of Queensland, St Lucia, Brisbane, Qld 4072
Country 147939 0
Australia
Phone 147939 0
+61 0409230698
Fax 147939 0
Email 147939 0
[email protected]
Contact person for scientific queries
Name 147940 0
Kate Witteveen
Address 147940 0
The University of Queensland, St Lucia, Brisbane, Qld 4072
Country 147940 0
Australia
Phone 147940 0
+61 0409230698
Fax 147940 0
Email 147940 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To maintain the privacy of participants.



What supporting documents are/will be available?

No Supporting Document Provided


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.