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
ACTRN12625001423404
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
25/11/2025
Date registered
Help: Date registered
17/12/2025
Date last updated
Help: Date last updated
17/12/2025
Date data sharing statement initially provided
Help: Data sharing statement date
17/12/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
The Richards Trauma Process: a novel psychotherapy that deserves a closer look
Scientific title
The Richards Trauma Process: a feasibility study of a novel psychotherapy in adults with elevated levels of depression, anxiety, stress or trauma symptoms
Additional trial identifiers [1] 316033 0
Nil known
Universal Trial Number (UTN)
U1111-1332-0941
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Major Depressive Disorder 339882 0
Anxiety Disorders 339883 0
Post-Traumatic Stress Disorder 339884 0
Condition category
Condition code
Mental Health 336119 336119 0 0
Anxiety
Mental Health 336120 336120 0 0
Depression
Mental Health 336121 336121 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Richards Trauma Process (TRTP) was offered to consecutive new clients of a psychotherapist (minimum 5 years experience) who has been accredited by Trauma Therapy Training Inc to deliver the therapy. TRTP was delivered as per protocol over 3-4 x 2-hour weekly sessions over 3-4 weeks, one-on-one either face-to-face at the therapist's clinic in Brisbane or via video conference. Although TRTP is a manualised therapy, with scripts and training provided by Trauma Therapy Training Inc., the therapy is adapted to the individual client's presentation according to the judgement of the therapist to deal with the specifics of the client's trauma history and its effects. TRTP adopts a broad definition of 'trauma' to include any distressing life event. The process involves psychoeducation about trauma and its effects on mental health; identification of unhelpful unconscious core beliefs arising from their trauma, and embracing their undamaged identity through a process known as 'embodied declarations'; and re-empowerment and re-parenting of the client's imagined younger self in relation to distressing memories through a form of hypnosis known as 'dynamic reimagining'. Adherence to the intervention was monitored by the therapist recording session attendance for each participant in the REDCap database.
Intervention code [1] 332643 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343653 0
Feasibility of studying TRTP
Timepoint [1] 343653 0
Process notes were collected during study design, recruitment and data collection phases, and outcomes were assessed against study criteria after data analysis was complete.
Secondary outcome [1] 455963 0
Feasibility of the intervention
Timepoint [1] 455963 0
Process notes were collected during study design, recruitment and data collection phases, and outcomes were assessed against study criteria after data analysis was complete.
Secondary outcome [2] 455965 0
Depression, anxiety, stress symptoms - composite outcome
Timepoint [2] 455965 0
Prior to commencement and at 1-month follow-up
Secondary outcome [3] 455966 0
Trauma symptoms
Timepoint [3] 455966 0
Prior to commencement of therapy and at 1-month follow-up

Eligibility
Key inclusion criteria
Consecutive new clients presenting for individual psychotherapy to a psychotherapist in suburban Brisbane, who are assessed as eligible for TRTP and accept that offer, and who demonstrate at least mildly elevated levels of depression, anxiety, stress or trauma symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Previous diagnosis of psychosis, Bipolar Disorder or Personality Disorder,
Inability to maintain sobriety during the therapy

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
As a feasibility study, formal sample-size calculations were not performed. However, prior to commencement, assuming a modest correlation between participants' pre-and post-treatment DASS scores between 0.3 and 0.5, we estimated that a sample of 20 participants would have between 80-90% power of detecting a treatment effect in the DASS score of 0.8 standard deviations. These assumptions were based on an unpublished audit of 715 clients treated with TRTP by 28 therapists in 2017-18 that reported effect sizes in the reduction in DASS21 scores of greater than 1 standard deviation. Previous research in people affected by trauma has shown that other therapy-based interventions can result in changes to the DASS21 of equivalent to 0.8 standard deviations or more.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/04/2023
Date of last participant enrolment
Anticipated
Actual
15/11/2023
Date of last data collection
Anticipated
Actual
14/03/2024
Sample size
Target
23
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 320634 0
University
Name [1] 320634 0
University of Melbourne
Country [1] 320634 0
Australia
Primary sponsor type
Individual
Name
Petrina Barson, University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 323258 0
None
Name [1] 323258 0
Address [1] 323258 0
Country [1] 323258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319175 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 319175 0
Ethics committee country [1] 319175 0
Australia
Date submitted for ethics approval [1] 319175 0
06/07/2022
Approval date [1] 319175 0
06/03/2023
Ethics approval number [1] 319175 0
2023-24751-37218-5

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

Contacts
Principal investigator
Name 146498 0
Dr Petrina Barson
Address 146498 0
Department of General Practice and Primary Care, University of Melbourne, Grattan St, Parkville, Victoria, 3010
Country 146498 0
Australia
Phone 146498 0
+61402464006
Fax 146498 0
Email 146498 0
[email protected]
Contact person for public queries
Name 146499 0
Petrina Barson
Address 146499 0
Department of General Practice and Primary Care, University of Melbourne, Grattan St, Parkville, Victoria, 3010
Country 146499 0
Australia
Phone 146499 0
+61402464006
Fax 146499 0
Email 146499 0
[email protected]
Contact person for scientific queries
Name 146500 0
Petrina Barson
Address 146500 0
Department of General Practice and Primary Care, University of Melbourne, Grattan St, Parkville, Victoria, 3010
Country 146500 0
Australia
Phone 146500 0
+61402464006
Fax 146500 0
Email 146500 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:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Studies testing whether findings can be repeated or confirmed
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?
• Journal publication or its supplementary materials: Tabulated individual participant scores will be offered as supplementary material when submitting for publication

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Letter.pdf
Informed consent form    2023.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.