Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000094471p
Ethics application status
Submitted, not yet approved
Date submitted
19/12/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial to Compare five sessions of Written Exposure Therapy for Post Traumatic Stress Disorder (PTSD) given weekly for five weeks or twice weekly for 2.5 weeks (known as the faster version) in a primary care setting participants.
Scientific title
A Randomised Controlled Trial to Compare five sessions of Written Exposure Therapy for PTSD given weekly for five weeks or twice weekly for 2.5 weeks (known as the faster version) in a primary care setting
Secondary ID [1] 313575 0
Nil known
Universal Trial Number (UTN)
U1111-1312-1151
Trial acronym
WRETFASTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder 336099 0
depression 336100 0
Condition category
Condition code
Mental Health 332656 332656 0 0
Other mental health disorders
Mental Health 332921 332921 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention of 4 sessions of written exposure therapy over two weeks (the faster option). There will be five 30-minute writing sessions where participants will be asked to write in detail what happened and what their emotions were about the event(s). When there are multiple events, they are asked to describe the one that has impacted them most. If they finish before the 30 minutes is over, they will be asked to start again from the beginning. The intervention will done by a clinician in the primary care team and done face to face or by Zoom if remote. If they have difficulty in writing, they can do it verbally into an audio recorder. They will do the writing in a private room. The location will be in a primary care clinician. We will record what we say as clinicians (interventions) for 10% of the consultations and have another investigator do a fidelity check. All participants will get five sessions. They do one before randomisation and if they return for a second one they will then be invited in to be randomisation. This is to prevent excessive dropouts
Intervention code [1] 330169 0
Behaviour
Comparator / control treatment
Intervention of 5 sessions of written exposure therapy over four weeks (regular option). The writing sessions will be identical i.e. 30 minutes per session. The first session will be done before randomisation. After the first treatment session the participants will be invited to be randomised. After randomisation the fast group will get twice weekly therapy for 2 weeks while the regular group will get once weekly sessions over 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 340157 0
The score on the Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5). This measures that presence and level of severity of symptoms of PTSD
Timepoint [1] 340157 0
After 4 sessions in the faster group compared with 2 session in the regular group I.e. at 2 weeks after randomisation
Primary outcome [2] 340158 0
Burns depression questionnaire about mood today known as the Burns Depression Scale (today version)
Timepoint [2] 340158 0
After 4 sessions in the faster group compared with 2 session in the regular group I.e. at 2 weeks after randomisation
Primary outcome [3] 340159 0
Patient Health Questionnaire-9 (PHQ-9). This measures 9 symptoms of depressions on a frequency basis. The more symptoms and the more frequently they are experienced the more severe the depression is.
Timepoint [3] 340159 0
After 4 sessions in the faster group compared with 2 session in the regular group I.e. at 2 weeks after randomisation
Secondary outcome [1] 443029 0
Depression severity
Timepoint [1] 443029 0
After each session
Secondary outcome [2] 443030 0
Burns Depression Scale (today version) after every session; score for depression on 0 to 20 scale with 5 or less being in remission. This questionnaire asks about five symptoms of depression right now. The options range from not at all = 0 to extremely = 4.
Timepoint [2] 443030 0
After each session
Secondary outcome [3] 443031 0
Emotional quality of life after every session; the score for depression on 0 to 100 scale
Timepoint [3] 443031 0
After every session
Secondary outcome [4] 443032 0
Hua oranga Maori quality of life score
Timepoint [4] 443032 0
At baseline before randomisation and after 5 sessions in both groups

Eligibility
Key inclusion criteria

1. Diagnosis of PTSD by a score of equal to or less than 35 on a PCL-5.
2. If taking psychotropic medication on a stable dose for at least 30 days before study entry
3. Aged 18 to 80
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current engagement in psychosocial treatment for PTSD.
2. Current diagnosis of severe substance use disorder. Those using heroin, other opiates, synthetic cannabis and methamphetamine will be excluded. (mild to moderate severity will not be excluded, e.g., alcohol and cannabis -participants using alcohol and cannabis will be asked not to use it on the days of doing WET therapy and for the day following WET therapy. This will protect against using substances as an avoidance tool for any post-therapy distress. We will need to make an individual decision about current substance use at the time of enrolment as there may be variations we have not considered.
3. Current psychosis or unstable bipolar disorder diagnosis.
4. High suicidal risk (i.e., intent with a plan).
5. Significant cognitive impairment (assessed with clinical judgement).
6. Inability to understand the ethics information sheet.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using excel function. The group will be stratified by gender male and female will be randomised separately
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Statistician input in terms of the data analysis will be sought. Continuous data analysis will be analysed using the student's t-test. Continuous data be tested for normality and non-parametric tests used if the data is non-normal. The analysis will be by intention to treat. Missing data will be managed by imputation.


Sample size calculation: We intend to recruit up to 26 participants per arm of the study. With 26 participants per arm, we anticipate being able to detect a 15-point difference in terms of PCL-5 from a score of 60 to 45 with an alpha of 0.05 and a beta of 0.2 or (two-sided). From the other WET RCTs, the SD range for the PCL range from 4.14 to 19.80. We have chosen 19 for the purpose of the sample size calculation. In the pilot work we have had effect sizes of 16, 25 and 35 so have chosen 15 as a conservative estimate. We will keep recruiting until we get 52 participants in the study.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
13/11/2025
Actual
Date of last data collection
Anticipated
12/12/2025
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 26780 0
New Zealand
State/province [1] 26780 0
Auckland

Funding & Sponsors
Funding source category [1] 318040 0
Charities/Societies/Foundations
Name [1] 318040 0
Whau foundation
Country [1] 318040 0
New Zealand
Funding source category [2] 318041 0
Charities/Societies/Foundations
Name [2] 318041 0
RNZCGP Charitable Trust
Country [2] 318041 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Whau Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 320386 0
Charities/Societies/Foundations
Name [1] 320386 0
RNZCGP Charitable Trust (national body)
Address [1] 320386 0
Country [1] 320386 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316695 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 316695 0
Ethics committee country [1] 316695 0
New Zealand
Date submitted for ethics approval [1] 316695 0
15/12/2024
Approval date [1] 316695 0
Ethics approval number [1] 316695 0

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

Contacts
Principal investigator
Name 138698 0
Prof Bruce Arroll
Address 138698 0
Auckland City Mission C/- 20 Masons Avenue Auckland 1011
Country 138698 0
New Zealand
Phone 138698 0
+64 21378180
Fax 138698 0
Email 138698 0
[email protected]
Contact person for public queries
Name 138699 0
Bruce Arroll
Address 138699 0
Auckland City Mission C/- 20 Masons Avenue Auckland 1011
Country 138699 0
New Zealand
Phone 138699 0
+64 21378180
Fax 138699 0
Email 138699 0
[email protected]
Contact person for scientific queries
Name 138700 0
Eunice Tao
Address 138700 0
Auckland City Mission PO Box 5232 Victoria Street 1142
Country 138700 0
New Zealand
Phone 138700 0
+64 211081932
Fax 138700 0
Email 138700 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:
• To all who make a genuine request

Conditions for requesting access:
• -

What individual participant data might be shared?
• All numerical data except names and dates of birth

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

When can requests for individual participant data be made (start and end dates)?
From:
The data will be available by 31 December 2024 and there is no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• by contacting Bruce Arroll [email protected]

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


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.