Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000087358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/12/2025
Date registered
Help: Date registered
23/01/2026
Date last updated
Help: Date last updated
23/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Young adults’ experiences and recovery in Uspace’s transdiagnostic and OCD-specific inpatient programs: a mixed-methods study of outcomes for young people with complex mental health conditions.
Scientific title
Real-World Hypothesis Testing of Uspace Transdiagnostic and OCD-Specific Inpatient Programs for Young Adults with Complex Mental Health Conditions: A Mixed-Methods Evaluation
Additional trial identifiers [1] 316128 0
Nil Know
Universal Trial Number (UTN)
Trial acronym
U-INSPIRE
Related trial records

Health condition
Health condition(s) studied:
Depression 340045 0
Anxiety 340047 0
Attention-Deficit/Hyperactivity Disorder (ADHD) 340048 0
Obsessive-Compulsive Disorder (OCD) 340049 0
Autistic Spectrum Disorders 340050 0
Condition category
Condition code
Mental Health 336249 336249 0 0
Anxiety
Mental Health 336250 336250 0 0
Autistic spectrum disorders
Mental Health 336251 336251 0 0
Depression
Mental Health 336252 336252 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study evaluates a package of non-drug interventions integrated into routine inpatient care at Uspace for young adults with complex mental health conditions, focusing on feasibility, safety, acceptability, and clinical outcomes over a typical admission episode.

Patients are admitted to Uspace under a transdiagnostic, routine-care General Program, and an OCD diagnosis may sometimes be identified or confirmed only during their inpatient stay, after comprehensive assessment and multidisciplinary review. This means a patient may enter the service as part of the “general” cohort and subsequently move into, or concurrently receive, OCD-specific interventions during the same admission.

Arm 1: Standard Group Therapy
Brief name: Standard transdiagnostic and OCD-specific group therapy.
Materials: Structured psychoeducational handouts, worksheets (for example, DBT skills sheets), and group guidelines are provided in printed and digital formats to support learning and peer discussion.
Procedures: Daily transdiagnostic groups focus on psychoeducation, emotional regulation, distress tolerance, interpersonal effectiveness, and peer support; for the OCD Program, additional psychoeducational and feedback groups for patients and families address OCD mechanisms, coping strategies, and service improvement. Participation is voluntary, with clear ground rules to support emotional safety and confidentiality.
Who delivers: Qualified mental health clinicians (clinical psychologists, psychiatrists, mental health nurses, and allied health staff) with experience in group therapy for young adults.
Mode of delivery: In-person, face-to-face group sessions on the inpatient unit, with some family sessions optionally including telehealth participation where clinically appropriate.
Number and timing:
General Program: Typically 1–2 group sessions per weekday, 45–60 minutes each, across the duration of the inpatient stay (approximately 2–6 weeks, depending on clinical need).
OCD Program: In addition to standard groups, OCD-specific psychoeducation and family sessions occur approximately once per fortnight during the admission, 60–90 minutes each.
Location/setting: Uspace 20-bed young adult inpatient mental health unit at St Vincent’s Private Hospital Sydney (specialist early-intervention service for young adults).
Adherence/fidelity: Attendance is recorded for each group; a standardised group program schedule and facilitator guides are used, and senior clinicians periodically review content and delivery to maintain fidelity to the therapeutic model.


Arm 2: MRI-Guided Transcranial Magnetic Stimulation (TMS)
Brief name: MRI-guided TMS for depression and OCD.
Materials: MRI scanner and neuronavigation system to identify cortical targets, TGA-approved TMS device with magnetic coil, treatment chair, safety questionnaires, and adverse-event monitoring templates.
Procedures: A baseline neurological and psychiatric assessment is completed, including standard safety screening. An MRI brain scan is used to localise target regions (for example, dorsolateral prefrontal cortex for treatment-resistant depression and OCD-relevant targets as available), followed by courses of repetitive TMS according to standard clinical protocols, with real-time observation and recording of side effects. Courses may be delivered either by radiographers with advanced training or by psychiatrists/nurses, always under consultant psychiatrist supervision, with the operator recorded prospectively for each session.
Who delivers: Consultant psychiatrists prescribe and supervise courses; TMS is administered by trained radiographers (linked radiology/TMS services) or Uspace psychiatrists/nurses with specific TMS training.
Mode of delivery: In-person, one-to-one sessions at partnered radiology/TMS clinics; MRI is delivered in standard radiology suites.
Number and timing: A typical course consists of approximately 20–30 sessions delivered 5 times per week over 4–6 weeks, with each TMS treatment session lasting about 20–40 minutes, consistent with routine clinical protocols.
Location/setting: Uspace inpatient unit (for assessment, referral, and follow-up) and partnered MRI/TMS facilities (for example, external radiology/TMS providers).
Adherence/fidelity: Treatment logs record session attendance, stimulation parameters, side effects, and operator; feasibility and fidelity are assessed by completeness of prescribed courses, adherence to protocol, documentation audits, and supervision with structured training resources to support operator competence.


Arm 3: Virtual Reality Exposure Therapy (VRET) and 2D Exposure Module (2DET)
Brief name: Virtual reality and digital exposure therapy for OCD.
Materials: VRET: VR headset, computer and software providing graded OCD-relevant exposure scenarios with adjustable intensity, and emergency stop controls.
2DET: A digital two-dimensional exposure module delivered via the secure MindSkiller platform or similar, using structured exposure tasks and psychoeducational content.
Procedures: A structured exposure hierarchy is developed collaboratively with the clinician. VRET sessions expose participants to virtual OCD-relevant triggers in a graded fashion with response-prevention coaching and monitoring of subjective distress; emergency stop and intensity controls support safety. 2DET sessions guide participants through non-immersive, screen-based exposure exercises completed in-session or as supported tasks between sessions, integrated with routine OCD therapy.
Who delivers: Clinical psychologists, psychiatrists, and other trained mental health clinicians with CBT/OCD expertise deliver and supervise VRET and 2DET sessions.
Mode of delivery: VRET: Face-to-face, one-to-one sessions using VR hardware in therapy rooms on the ward.
2DET: Individual, digitally mediated exposure tasks accessed on ward computers or personal devices under clinician guidance.
Number and timing: VRET: Typically 4–8 sessions per admission, 30–60 minutes per session, 1–2 times weekly depending on length of stay and clinical tolerance, commencing after assessment and consent.
2DET: Shorter, more frequent modules (for example, 2–3 times per week, 15–30 minutes each) embedded in the inpatient schedule, with optional follow-up use post-discharge.
Location/setting: Uspace inpatient unit (therapy rooms or quiet spaces) using secure hardware and networked access to the software platform.
Adherence/fidelity: Session logs capture attendance, scenario type, duration, distress ratings, and early termination; standardised exposure protocols and session checklists are used, and MindSkiller-linked tools allow monitoring of utilisation and symptom change over time.


Arm 4: Virtual Reality Positive Memory Enhancement (VRPME)
Brief name: VR-based AI-assisted positive memory enhancement for depression and anxiety.
Materials: VR headset and software delivering immersive positive or soothing environments combined with AI-assisted therapeutic scripts guiding positive memory recall and cognitive re-scripting.
Procedures: Participants engage in structured sessions in which they are prompted to recall and elaborate positive or mastery-oriented memories while immersed in tailored VR scenarios (for example, calming nature environments), with a clinician supporting emotion regulation and cognitive restructuring.
Who delivers: Clinical psychologists, psychiatrists, or other trained mental health clinicians with experience in trauma-informed and cognitive therapies for young adults.
Mode of delivery: Individual, face-to-face sessions using VR equipment in designated therapy spaces on the ward.
Number and timing: Approximately 3–6 sessions per admission, 30–45 minutes each, usually 1–2 times per week depending on symptom severity, engagement, and length of stay.
Location/setting: Uspace inpatient unit, in VR-capable therapy rooms or quiet spaces.
Adherence/fidelity: Standard VRPME protocols and scripting templates are used; session notes document content, emotional responses, and any adverse events, and adverse event registers track side effects such as dizziness or nausea.


Arm 5: Mental Health Literacy eLearning Platform (MindSkiller)
Brief name: MindSkiller digital mental health literacy and research platform.
Materials: MindSkiller online platform providing interactive psychoeducational modules, multimedia content, knowledge checks, and scenario-based learning for depression, anxiety, OCD, and transdiagnostic topics, as well as secure case report and outcome-measure modules for research data capture.
Procedures: Participants complete tailored learning pathways on MindSkiller during admission (for example, diagnosis-specific modules, coping skills, treatment options), while clinicians review progress and link content to individual care plans; the platform concurrently collects symptom and functioning outcomes via standardised questionnaires.
Who delivers: Content and oversight are provided by consultant psychiatrists and clinical psychologists with digital mental health expertise; ward clinicians encourage and support patient use.
Mode of delivery: Digital, self-paced eLearning accessed individually on personal devices or ward computers, supported by brief face-to-face check-ins with clinicians as needed.
Number and timing: Participants are encouraged to complete several core modules during their inpatient stay (for example, 3–6 modules, 20–40 minutes each) plus optional additional content, typically a few sessions per week aligned with individual capacity and length of stay.
Location/setting: Uspace inpatient unit and, where feasible, post-discharge at home via secure login to the MindSkiller platform.
Adherence/fidelity: Platform analytics track log-ins, duration of use, modules completed, and quiz performance; clinicians review engagement reports and prompt completion where appropriate, and standardised modules with version control ensure protocol consistency during the study period.


Personalisation and Fidelity Across Arms
Personalisation: All interventions are embedded in a person-centred inpatient model in which treatment plans are tailored to diagnosis, symptom severity, comorbidities, and patient preferences, with the intensity and combination of group therapy, TMS, VR/2DET, VRPME, and MindSkiller adjusted collaboratively in multidisciplinary meetings.


Fidelity: Structured protocols, manuals, and digital pathways are used for each intervention, with routine documentation of attendance, dose, adverse events, and operator type (for example, radiographer versus psychiatrist/nurse for TMS), plus periodic supervision and audit by senior clinicians to support fidelity assessment.
Intervention code [1] 332734 0
Treatment: Devices
Intervention code [2] 332735 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343795 0
Change in anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) total score.
Timepoint [1] 343795 0
At admission (baseline), approximately 3 weeks after admission (primary timepoint, or at discharge if earlier), and at post-discharge follow-up (e.g. 6–8 weeks after discharge, as specified in the protocol schedule).
Primary outcome [2] 343796 0
Change in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) total score.
Timepoint [2] 343796 0
At admission (baseline), approximately 3 weeks after admission (primary timepoint, or at discharge if earlier), and at post-discharge follow-up (e.g. 6–8 weeks after discharge).
Primary outcome [3] 343797 0
Change in OCD symptom severity measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score for participants with OCD.
Timepoint [3] 343797 0
At admission (baseline), approximately 3 weeks after admission (primary timepoint, or at discharge if earlier), and at post-discharge follow-up (e.g. 6–8 weeks after discharge).
Secondary outcome [1] 455653 0
Change in psychological distress measured by the Depression Anxiety Stress Scales-21 (DASS-21) total and subscale scores.
Timepoint [1] 455653 0
At admission (baseline), approximately 3 weeks after admission (or at discharge if earlier), and at post-discharge follow-up (e.g. 6–8 weeks after discharge).
Secondary outcome [2] 455654 0
Change in quality of life measured by the Mental Health Quality of Life scale (MHQ-14) total score.
Timepoint [2] 455654 0
At admission (baseline), approximately 3 weeks after admission (or at discharge if earlier), and at post-discharge follow-up (e.g. 6–8 weeks after discharge).
Secondary outcome [3] 455655 0
Change in occupational and role functioning measured by the Sheehan Disability Scale (SDS) total score. This will be assessed as a composite outcome.
Timepoint [3] 455655 0
At admission (baseline), approximately 3 weeks after admission (or at discharge if earlier), and at post-discharge follow-up (e.g. 6–8 weeks after discharge).
Secondary outcome [4] 455656 0
Patient experience and satisfaction with care measured by the Australian Hospital Patient Experience Question Set (AHPEQS) summary scores. This will be assessed as a composite outcome.
Timepoint [4] 455656 0
At discharge and at post-discharge follow-up (e.g. 6–8 weeks after discharge), where feasible.

Eligibility
Key inclusion criteria
Eligible participants are young adults admitted to Uspace who can provide informed consent and complete study measures.

In addition, some participants are initially admitted under the general, transdiagnostic inpatient program and, during the course of their admission, are identified as having clinically significant obsessive–compulsive symptoms or a formal OCD diagnosis following comprehensive psychiatric assessment and multidisciplinary review (including structured diagnostic interview, review of longitudinal history, and standardised symptom measures such as the Yale–Brown Obsessive Compulsive Scale or equivalent clinician-rated tools). These participants may subsequently enter, or simultaneously receive, OCD-specific interventions within the same admission episode.

Core inclusion criteria
Age 16–30 years at the time of admission to Uspace.

Current inpatient of Uspace, St Vincent’s Private Hospital Sydney, admitted to the General or OCD Program under routine clinical pathways.

Sufficient English fluency to understand study information and complete questionnaires and digital modules.

Capacity to provide informed consent to research participation, assessed according to hospital consent policy; for 16–17-year-olds, independent consent is permitted if capacity is demonstrated.

Intervention-specific eligibility (summary)
Eligibility for non-standard adjunctive interventions (e.g. MRI-guided TMS, VR therapies, 2D exposure modules) requires non-response or insufficient response to at least one guideline-endorsed evidence-based therapy (such as CBT and/or SSRI) for the relevant condition, documented in the clinical record.

TMS interventions are limited to adults (18 years or older) under routine TGA approval; use in 16–17-year-olds, where considered, is on a case-by-case basis with enhanced consent.
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Key exclusion criteria focus on situations where participation would be unsafe, infeasible, or inconsistent with the study’s aims.

Global study-level exclusions
Inability to provide informed consent due to impaired decision-making capacity, acute cognitive impairment, or communication difficulties that prevent understanding of study information and completion of questionnaires, even with support.

Patients whose admission pathway does not meet Uspace’s standardised intake inclusion/exclusion criteria for the 16–30-year-old inpatient service (e.g. primary need for a different level of care or service type).

Decline or withdrawal of consent for research use of routine clinical data (clinical care continues, but data are not included in the study).

Intervention-specific safety and feasibility exclusions
TMS-specific exclusions: patients with known contraindications to MRI or TMS (e.g. seizure disorder, non-compatible metal implants, or other standard TMS safety red flags), and all patients under 16 years; use in 16–17-year-olds is restricted to exceptional, case-by-case circumstances and otherwise considered unsuitable.

VR / digital exposure / VRPME exclusions: patients with conditions that make immersive or screen-based interventions unsafe or impractical (e.g. epilepsy, severe motion sickness, severe dissociation or psychosis that would be destabilised by VR, or inability to use digital interfaces).

Exclusions related to prior treatment and indication
For novel, non-standard adjunctive interventions (e.g. MRI-guided TMS, VRET, 2D exposure modules), patients without documented non-response to at least one guideline-endorsed evidence-based therapy (CBT and/or SSRI) for the relevant diagnosis are excluded from those specific arms, as the study targets treatment-refractory or complex presentations.

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
Other
Other design features
The study is a naturalistic, mixed-methods evaluation of routine inpatient care and optional adjunctive interventions at Uspace, without random allocation.

This is a pragmatic, mixed-methods evaluation embedded within routine inpatient care, with flexible, clinically driven allocation to transdiagnostic and OCD-specific intervention components. Participants are not randomised to mutually exclusive arms; instead, they may move from the general program into the OCD-specific program, or receive both in parallel, depending on assessments conducted during the admission. The design therefore accommodates time-varying intervention exposure and allows participants’ clinical pathway (general only, OCD-specific only, or combined exposure) to be modelled descriptively and analytically)
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The overarching design of the U-INSPIRE protocol is a naturalistic, mixed-methods evaluation of Uspace’s inpatient programs, encompassing both transdiagnostic and diagnosis-specific pathways (General Program and OCD Program) within a single integrated model of care, with shared infrastructure, measures, and routine care processes. Quantitative and qualitative components are embedded within routine clinical workflows, so that data collection, follow-up, and feedback to the service reflect real-world inpatient practice rather than a tightly controlled experimental trial.

Analytically, the protocol is structured to examine both streams within one real-world hypothesis-testing framework, using common core outcomes (for example, depression, anxiety, functioning, and distress) across all inpatients, while also conducting intervention- and stream-specific analyses as pre-planned subgroups. OCD-specific components (for example, Y-BOCS, virtual reality–based exposure, 2D exposure tasks, and OCD-focused group therapy) are embedded as adjuncts within the same overarching cohort, not as a separate recruitment pathway or standalone trial, and are evaluated as optional, adjunctive elements alongside routine multidisciplinary care.

Because allocation to the General versus OCD stream forms part of routine clinical decision making rather than a pre-specified research recruitment frame, admissions and diagnostic refinement are continuous and dynamic across the typical three-week inpatient episode. A proportion of patients will have comorbid or emerging OCD features identified only after admission, and some will receive a mix of general and OCD-specific interventions, making it neither feasible nor desirable to allocate them cleanly to non-overlapping “General-only” and “OCD-only” studies without introducing substantial selection bias and undermining external validity. The single-protocol, fluid mixed-methods framework preserves the integrity of the rolling cohort and aligns with the primary objective: to evaluate feasibility, safety, acceptability, and signals of benefit for Uspace’s integrated inpatient programs for young adults with complex mental health conditions, rather than to conduct two independent, siloed clinical trials.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
29/12/2028
Actual
Date of last data collection
Anticipated
28/12/2029
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 28857 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 45113 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 320720 0
Hospital
Name [1] 320720 0
St Vincent’s Health Network (St Vincent’s Private Hospital Sydney / Uspace)
Country [1] 320720 0
Australia
Primary sponsor type
Hospital
Name
St Vincent’s Health Network (St Vincent’s Private Hospital Sydney / Uspace)
Address
Country
Australia
Secondary sponsor category [1] 323381 0
Charities/Societies/Foundations
Name [1] 323381 0
Cunningham Foundation
Address [1] 323381 0
Country [1] 323381 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319260 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 319260 0
Ethics committee country [1] 319260 0
Australia
Date submitted for ethics approval [1] 319260 0
01/05/2025
Approval date [1] 319260 0
19/11/2025
Ethics approval number [1] 319260 0

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

Contacts
Principal investigator
Name 146786 0
A/Prof Gary Galambos
Address 146786 0
USpace Level 7 O'Brien Building, Crn Burton & Victoria streets, Darlinghurst NSW 2010
Country 146786 0
Australia
Phone 146786 0
+61 283829770
Fax 146786 0
Email 146786 0
[email protected]
Contact person for public queries
Name 146787 0
Gary Galambos
Address 146787 0
USpace Level 7 O'Brien Building, Crn Burton & Victoria streets, Darlinghurst NSW 2010
Country 146787 0
Australia
Phone 146787 0
+61 283829770
Fax 146787 0
Email 146787 0
[email protected]
Contact person for scientific queries
Name 146788 0
Gary Galambos
Address 146788 0
USpace Level 7 O'Brien Building, Crn Burton & Victoria streets, Darlinghurst NSW 2010
Country 146788 0
Australia
Phone 146788 0
+61 283829770
Fax 146788 0
Email 146788 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    Patient consent Form U_INSPIRE - PCFU18 V1 14 October 2025.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.