Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12622001384741
Ethics application status
Approved
Date submitted
21/10/2022
Date registered
28/10/2022
Date last updated
28/10/2022
Date data sharing statement initially provided
28/10/2022
Date results provided
28/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rewriting Grief and Loss: A Pilot Writing-For-Wellbeing Study with participants who have experienced bereavement and non-death losses
Scientific title
Rewriting Grief and Loss: A Pilot Writing-For-Wellbeing Study with participants who have experienced bereavement and non-death losses to assess the feasibility, acceptability, and potential efficacy of this writing intervention to help participants to work through their grief to facilitate adaptation.
Secondary ID [1] 308220 0
Ni known
Universal Trial Number (UTN)
U1111-1283-8069
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grief 327975 0
Prolonged grief 327976 0
Condition category
Condition code
Mental Health 325033 325033 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 325034 325034 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Rewriting Grief and Loss: A Pilot Writing-For-Wellbeing Study

Participants took part in six weekly 2.5-hour sessions, which included two writing exercises followed by sharing after each. Each of the 12 writing exercises lasted 20–30 minutes and had different and varied writing instructions. Writing-for-wellbeing writing prompts are inclusive of creative, imaginary, expressive, and metaphorical writing. The writing exercises used Free-Flow Writing (FFW), a technique that works on the principle of free association. Participants are given a set of guidelines that are designed to access thoughts and feelings by free association, without revision, editing or correction and write for a set time (Killick & Schneider, 2010).
Killick, J., & Schneider, M. (2010) Writing yourself. Continuum.
Participants used their own pens and were provided with a folder with paper.
Adherence was monitored through session attendance checklists.

The Writing-for-wellbeing intervention was delivered by an experienced practitioner who holds a doctorate in Creative Writing with a research focus on grief, bereavement and narrative psychology. The study was undertaken by the same scholar and a co-investigator who is a Professor of psychology.

The intervention was delivered face-to-face in a group setting
There were two groups. Group one had 10 bereaved participants and Group 2 had 10 participants who had experienced a range of non-death losses

Location: The intervention was held April to May 2021 in Perth, Australia, at the premises of the Grief Centre of Western Australia, 105 Banksia Street, Tuart Hill WA 6060.
Intervention code [1] 324679 0
Behaviour
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332854 0
Adaptive coping was measured with The Coping Assessment for Bereavement and Loss Experiences (CABLE, Crunk et al., 2021). We adapted this for use with the non-death losses group. The opening instructions were minimally altered whereby the phrase “following the death of a loved one” was changed to “following a stressful loss such as divorce, life-threatening illness, pandemic related losses such as social isolation, fear of the future or unemployment” Four items specific to the ongoing relation to the deceased were omitted, resulting in 24 items for this group.
Crunk, A. E., Burke, L. A., Neimeyer, R. A., Robinson, E. H. M., & Bai, H. (2021). The coping assessment for bereavement and loss experiences (CABLE): Development and initial validation. Death studies, 45(9), 677-691.
Timepoint [1] 332854 0
Pre-intervention, post-completion of intervention (primary timepoint), one-month after post-completion of intervention follow up
Primary outcome [2] 332855 0
Meaning-reconstruction was measured using the The Integration of Stressful Life Experiences Scale (ISLES Holland et al., 2010)
Holland, J. M., Currier, J. M., Coleman, R. A., & Neimeyer, R. A. (2010). The Integration of Stressful Life Experiences Scale (ISLES): Development and initial validation of a new measure. International Journal of Stress Management, 17(4), 325-352.
Timepoint [2] 332855 0
Pre-intervention, post-completion of intervention (primary timepoint), one-month after post-completion of intervention follow up
Primary outcome [3] 332856 0
Acceptability was measured with a satisfaction questionnaire adapted from Wenn et al. (2015), which has 19 questions that are rated on a scale from 1 (not at all) to 5 (very much).
Wenn, J., O'Connor, M., Breen, L. J., Kane, R. T., & Rees, C. S. (2015). Efficacy of metacognitive therapy for prolonged grief disorder: Protocol for a randomised controlled trial. BMJ Open, 5(12), e007221.
Timepoint [3] 332856 0
Pre-intervention, post-completion of intervention (primary timepoint), one-month after post-completion of intervention follow up
Secondary outcome [1] 414875 0
Feasibility (primary outcome) was measured in relation to enrolment, retention, and attendance. Enrolment was measured by the number of participants who attended the intervention.. Attendance and retention were assessed via the attendance checklist.
Timepoint [1] 414875 0
At completion of study
Secondary outcome [2] 414876 0
Prolonged grief (primary outcome) was measured with The Prolonged Grief Scale (PG-13; Prigerson & Maciewjewski, 2006)
Prigerson, H. G., & Maciejewski, P.K. (2006). Prolonged grief disorder (PG-13). Dana-Farber Cancer Institute: Boston, MA.
Timepoint [2] 414876 0
Pre-intervention, post-completion of intervention (primary timepoint), one-month after post-completion of intervention follow up
Secondary outcome [3] 414877 0
Depression: The PHQ-4 scale was used with four questions (Kroenke et al., 2009)
Kroenke, K., Spitzer, R. L., Williams, J. B., & Löwe, B. (2009). An ultra-brief screening scale for anxiety and depression: the PHQ–4. Psychosomatics, 50(6), 613-621.
Timepoint [3] 414877 0
Pre-intervention, post-completion of intervention, one-month after post-completion of intervention follow up
Secondary outcome [4] 414878 0
Anxiety: The PHQ-4 scale was used with four questions (Kroenke et al., 2009).
Kroenke, K., Spitzer, R. L., Williams, J. B., & Löwe, B. (2009). An ultra-brief screening scale for anxiety and depression: the PHQ–4. Psychosomatics, 50(6), 613-621.
Timepoint [4] 414878 0
Pre-intervention, post-completion of intervention, one-month after post-completion of intervention follow up

Eligibility
Key inclusion criteria
Adults. Participants have to be literate and able to understand English, there are no special writing skills necessary,
Participants must have experienced grief either due to bereavement or another significant loss such as life-threatening illness, divorce, infertility, or caring for an elderly parent with dementia. No limitation was placed on how long ago the loss occurred. The rationale underpinning this decision was to allow people the opportunity to actively address their grief even a long time after their loss occurred.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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 design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/04/2021
Date of last participant enrolment
Anticipated
Actual
16/04/2021
Date of last data collection
Anticipated
Actual
22/06/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 38789 0
6060 - Tuart Hill

Funding & Sponsors
Funding source category [1] 312475 0
Other
Name [1] 312475 0
Lotterywest
Country [1] 312475 0
Australia
Primary sponsor type
Individual
Name
Dr. Katrin Den Elzen
Address
Curtin University, Perth campus, Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 314071 0
Individual
Name [1] 314071 0
Professor Emeritus Robert Neimeyer
Address [1] 314071 0
The Portland Institute for Loss and Transition.
1025 SW Market St, Portland, Oregon, 97201, United States
Country [1] 314071 0
United States of America
Other collaborator category [1] 282462 0
Charities/Societies/Foundations
Name [1] 282462 0
The Grief Centre of Western Australia
Address [1] 282462 0
105 Banksia Street, Tuart Hill WA 6060
Country [1] 282462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311818 0
Human Research Ethics Committee, Curtin University
Ethics committee address [1] 311818 0
Ethics committee country [1] 311818 0
Australia
Date submitted for ethics approval [1] 311818 0
11/09/2020
Approval date [1] 311818 0
19/02/2021
Ethics approval number [1] 311818 0
HRE2021-0075

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

Contacts
Principal investigator
Name 122474 0
Dr Katrin Den Elzen
Address 122474 0
Curtin University. Kent St, Bentley WA 6102
Country 122474 0
Australia
Phone 122474 0
+61487029983
Fax 122474 0
Email 122474 0
[email protected]
Contact person for public queries
Name 122475 0
Katrin Den Elzen
Address 122475 0
Curtin University. Kent St, Bentley WA 6102
Country 122475 0
Australia
Phone 122475 0
+61487029983
Fax 122475 0
Email 122475 0
[email protected]
Contact person for scientific queries
Name 122476 0
Robert Neimeyer
Address 122476 0
Portland Institute for Loss and Transition,
1025 SW Market St, Portland, Oregon, 97201, United States
Country 122476 0
United States of America
Phone 122476 0
+15032241137
Fax 122476 0
Email 122476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data are not publicly available due to requirements of the Curtin Human Research Ethics Committee (e.g., their containing information that could compromise the privacy of research 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.