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Trial registered on ANZCTR


Registration number
ACTRN12620001065987
Ethics application status
Approved
Date submitted
24/07/2020
Date registered
16/10/2020
Date last updated
16/07/2021
Date data sharing statement initially provided
16/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding the role of therapeutic writing interventions as a treatment for adults experiencing post-traumatic stress
Scientific title
Investigating the effect of therapeutic writing interventions on the severity of post-traumatic stress symptoms in adult Australians
Secondary ID [1] 301743 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Symptoms (PTS) 318203 0
Condition category
Condition code
Mental Health 316209 316209 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of three writing conditions (two experimental and one control).

Intervention condition 1: Repeated Written Recounting.
Repeated Written Recounting is a structured writing intervention that emphases repeated recounting (also known as 'exposure') of the traumatic event. It is an adapted version of Sloan and colleagues (2018) 'Written Exposure Therapy.' It involves three 20-minute writing sessions spaced one week apart, in detail, about emotions, physical sensations, and thoughts, related to the traumatic event.

Intervention condition 2: Written Cognitive Reprocessing.
Written Cognitive Reprocessing is a structured writing intervention that emphasises processing of the traumatic event, cognitive restructuring, and social sharing. It is an adapted version of Lange and colleagues' (2000) 'Interapy'. It involves three 20-minute writing sessions spaced one week apart, instructing participants to make meaning of the trauma, write about the trauma as if it happened to a friend, and take symbolic leave from the trauma.

Both experimental conditions involve the following:
Three writing sessions spaced one week apart.
All sessions are completed online in a teleconference with the primary researcher. The researcher will be located in a private room at the Research School of Psychology, Australian National University.
A 5-10 minute check-in prior to writing task, to discuss progress over past week, and any questions or concerns.
A 5-10 minute debrief after the writing task to discuss experiences during writing, and any questions or concerns.
In session one, participants are provided with 20-minutes of psychoeducation about trauma reactions, maintaining features of PTS, and how writing may help.
After each session, participants will be emailed a handout devised by researchers on how to allow themselves to continue confronting trauma memories as they come up in-between writing sessions (how to identify what is happening, how to allow thoughts, feelings and images to wash over, and what to do if it becomes too overwhelming).
Participants' assigned researcher will read over the submitted essay (provided participant has consented to submitting their writing task) to monitor adherence to writing instructions and provide feedback at the following appointment.


Intervention code [1] 318040 0
Treatment: Other
Intervention code [2] 318395 0
Behaviour
Comparator / control treatment
Control condition: Positive Emotions Writing.
Positive Emotions Writing is a structured writing intervention adapted from Burton and King (2004). Participants are asked to write in depth about positive past memories. There is emphasis on detailing the emotions associated with the positive experience. Participants complete three 20-minute writing sessions, spaced one week apart.

The control condition contains the following additional procedures, similar to the experimental conditions:
All sessions are completed online in a teleconference with the primary researcher. The researcher will be located in a private room at the Research School of Psychology, Australian National University.
A 5-10 minute check-in prior to writing task, to discuss progress over past week, and any questions or concerns.
A 5-10 minute debrief after the writing task to discuss experiences during writing, and any questions or concerns.
Control group
Active

Outcomes
Primary outcome [1] 324543 0
Change in PTSD symptom severity as measured on the Post traumatic stress disorder checklist (PCL-5).
Timepoint [1] 324543 0
Prior to writing session 1 (baseline), prior to writing session 2 (mid-intervention), prior to writing session 3 (mid-intervention), one-week post-intervention, and one-month follow-up.
Secondary outcome [1] 384938 0
Change in levels of Depression, Stress and Anxiety as measured on the DASS-21.
Timepoint [1] 384938 0
Prior to writing session 1 (baseline), prior to writing session 2 (mid-intervention), prior to writing session 3 (mid-intervention), one-week post-intervention, and one-month follow-up.
Secondary outcome [2] 384939 0
Change in self-compassion as measured by the Self-Compassion Scale (SCS).
Timepoint [2] 384939 0
Prior to writing session 1 (baseline), prior to writing session 2 (mid-intervention), prior to writing session 3 (mid-intervention), one-week post-intervention, and one-month follow-up.
Secondary outcome [3] 384940 0
Change in perceived social support as measured by the Social Provisions Scale (SPS).
Timepoint [3] 384940 0
Prior to writing session 1 (baseline), prior to writing session 2 (mid-intervention), prior to writing session 3 (mid-intervention), one-week post-intervention, and one-month follow-up.
Secondary outcome [4] 384941 0
Change in trauma-related cognition as measured by the Posttraumatic Cognition Inventory-brief version (PTCI-9)
Timepoint [4] 384941 0
Prior to writing session 1 (baseline), prior to writing session 2 (mid-intervention), prior to writing session 3 (mid-intervention), one-week post-intervention, and one-month follow-up.
Secondary outcome [5] 384942 0
Pre- and post-intervention perceived credibility and expectancy adapted from Devilly and Borkovec, 2000.
Timepoint [5] 384942 0
Prior to writing session 1 (baseline), one-week post-intervention.
Secondary outcome [6] 384943 0
In-session changes in harm expectancy (i.e., 'Expectancy Violation') adapted from de Klein et al., 2017.
Timepoint [6] 384943 0
Pre- and post-writing session 1; pre- and post-writing session 2; pre- and post-writing session 3.

Eligibility
Key inclusion criteria
Adults residing in Australia who have experienced a traumatic event that still distresses them (according to endorsement of at least one symptom of each B-E criteria on PCL-5).
Willingness to write about traumatic event in detail.
Willingness to be allocated randomly to one of three conditions.
If on medication, currently taking a stable dose for over a month.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently undergoing psychotherapy elsewhere (no exclusion for past psychotherapy that has concluded).
Dissociative tendency.
Current alcohol or drug abuse.
Current suicidality.
History or current psychosis.
Likely to be inaccessible for the 3 weeks of writing.
Unable to write in English.

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)
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
Analyses will be conducted as intent-to-treat from randomisation. The primary outcome measure will be reductions in posttraumatic stress symptoms as measured by the PCL-5. Secondary outcome measure will be reductions in depression, anxiety and stress as measured by the DASS-21. Linear mixed effect modelling analysis will be used to compare groups on mean scores of primary and secondary outcomes, Covariates considered will be previous disclosure, time since trauma, past therapy, age, gender, ethnicity, symptom severity at baseline, and trauma type.
Process evaluations will examine moderators of outcomes and change in mediator variables. Candidate moderators include baseline symptom severity, previous disclosure, age, gender, Candidate mediators include trauma-related cognitions, perceived social support, self-compassion and expectancy violation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306298 0
University
Name [1] 306298 0
Australian National University
Address [1] 306298 0
Research School of Psychology
Building 39
Science Road
Canberra
ACT
2601
Country [1] 306298 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Research School of Psychology
Building 39
Science Road
Canberra
ACT
2601
Country
Australia
Secondary sponsor category [1] 306791 0
None
Name [1] 306791 0
Address [1] 306791 0
Country [1] 306791 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306390 0
ANU HREC
Ethics committee address [1] 306390 0
Research Services Division
Geography Building 48A Linnaeus Way
Australian National University
Acton
ACT
2601
Ethics committee country [1] 306390 0
Australia
Date submitted for ethics approval [1] 306390 0
09/06/2020
Approval date [1] 306390 0
14/08/2020
Ethics approval number [1] 306390 0
2020/334

Summary
Brief summary
Prominent treatments for post-traumatic stress (PTS) involve confronting the traumatic memory and associated thoughts, feelings and sensations. There is recent evidence to suggest that such treatment methods may not need be extensive and may be effective in a short-term intervention, such as structured writing. The proposed research aims to explore the effectiveness of two experimental writing paradigms in comparison to a control, for producing change in PTS symptoms. The research additionally aims to explore the factors that promote recovery (i.e. mechanisms of change). In particular, it will explore the role of each of four putative mechanisms: (1) changing learnt expectation of distress on recounting, (2) changing thinking about the event, (3) self-compassion, and (4) social sharing). It is hypothesised that the experimental conditions will produce change in PTS symptoms in comparison to the control; and that the factors which will account for these changes (i.e. mechanisms) will differ depending on type of writing condition and its associated underlying theoretical paradigm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103714 0
Ms Rachelle Dawson
Address 103714 0
Research School of Psychology
Building 39
Science Road
Australian National University
Acton
Canberra
ACT
2601
Country 103714 0
Australia
Phone 103714 0
+61 2 6125 2783
Fax 103714 0
Email 103714 0
rachelle.dawson@anu.edu.au
Contact person for public queries
Name 103715 0
Ms Rachelle Dawson
Address 103715 0
Research School of Psychology
Building 39
Science Road
Australian National University
Acton
Canberra
ACT
2601
Country 103715 0
Australia
Phone 103715 0
+61 2 6125 2783
Fax 103715 0
Email 103715 0
rachelle.dawson@anu.edu.au
Contact person for scientific queries
Name 103716 0
Ms Rachelle Dawson
Address 103716 0
Research School of Psychology
Building 39
Science Road
Australian National University
Acton
Canberra
ACT
2601
Country 103716 0
Australia
Phone 103716 0
+61 2 6125 2783
Fax 103716 0
Email 103716 0
rachelle.dawson@anu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Informed consent form
Other
'Other' documents specified
Participant Information Sheet
How or where can supporting documents be obtained?
Type [1] 9204 0
Informed consent form
Citation [1] 9204 0
Link [1] 9204 0
Email [1] 9204 0
rachelle.dawson@anu.edu.au
Other [1] 9204 0
Attachment [1] 9204 0
Type [2] 9205 0
Other
Citation [2] 9205 0
Link [2] 9205 0
Email [2] 9205 0
rachelle.dawson@protonmail.com
Other [2] 9205 0
Attachment [2] 9205 0
Summary results
No Results