Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000631808
Ethics application status
Approved
Date submitted
24/03/2021
Date registered
27/05/2021
Date last updated
19/05/2022
Date data sharing statement initially provided
27/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the "Living with Loss" program: An online perinatal bereavement program for psychological distress and emotional wellbeing of parents following perinatal loss.
Scientific title
Emotional wellbeing of parents after perinatal loss: A randomised controlled trial comparing the efficacy and acceptability of an online perinatal bereavement program "Living with Loss" to usual care.
Secondary ID [1] 303182 0
None
Universal Trial Number (UTN)
Trial acronym
LWL RCT
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
psychological distress 320308 0
stillbirth 320309 0
grief 320310 0
depression 320311 0
perinatal loss 320312 0
neonatal death
 320313 0
bereavement 320314 0
Condition category
Condition code
Mental Health 318229 318229 0 0
Depression
Reproductive Health and Childbirth 319383 319383 0 0
Complications of newborn
Reproductive Health and Childbirth 319384 319384 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled trial evaluating the efficacy and acceptability of a self-guided internet-based (i.e. online) perinatal bereavement program - 'Living with Loss' - compared to usual care in improving the psychosocial and emotional wellbeing of parents following perinatal loss. The 'Living with Loss' online program consists of six modules featuring interactive activities, information, and a comic-style storyline. Modules will take approximately 30 minutes each to complete, and are designed to be completed in any order over a period of six-to-eight weeks (i.e. one module recommended to be completed per week with an additional two weeks for revision). Using the software reporting function, the research team will be able to view incomplete modules and encourage participants to finish via an automated email system. The total duration of the study period including follow-up will be six (6) months.

This online perinatal bereavement program aims to support parents through their grief experience and focuses on enhancing and building adaptive coping strategies to help parents identify, tolerate, and gain more control over the regulation of their emotional experiences. This online program includes skills and strategies from several psychotherapeutic modalities (i.e. Cognitive Behavioural Therapy, Complicated Grief Therapy, Mindfulness, and Compassion-focused therapy) with content specifically addressing the most commonly reported psychosocial difficulties experienced by parents after the death of their baby (e.g. understanding styles of grieving, managing worry and intense emotions, facing difficult conversations, returning to work, relationships and communication, planning for the future etc).

This online program has been co-developed and designed by a team of perinatal clinicians and researchers, bereaved parents, and community-based HCPs and parent support organisations (e.g. Stillbirth Foundation Australia, Red Nose, Sands, Bears of Hope).
Intervention code [1] 319520 0
Behaviour
Intervention code [2] 320330 0
Treatment: Other
Comparator / control treatment
All participants randomised to the usual care control condition will be able to access care from their health services (i.e. continue with any course of treatment already specified to take, such as accessing peer support services). Participants will be asked to notify the research team if they commence any new treatment or support during the research trial.

Over the 21-week study period, participants will complete 3 sets of online study questionnaires about their mental health (e.g. distress, depression etc) and quality of life. At the conclusion of the study period, participants in the control group will be offered access to the Living with Loss online program via their secure participant portal.
Control group
Active

Outcomes
Primary outcome [1] 326250 0
Psychological distress severity: Changes in score from baseline on the Kessler Psychological Distress 10-item Scale (K10)
Timepoint [1] 326250 0
The primary outcome will be assessed in the control group at two timepoints: Week 9 (primary timepoint) and week 21.

The primary outcome will be assessed in the intervention group at the following timepoints: once weekly during the eight-week active study period (weeks 1-8); 1 week after program completion (week 9 post-intervention commencement, primary timepoint); at the 3-month follow-up (week 21 post-intervention commencement), and at the 6-month follow up (week 33 post-intervention commencement).
Secondary outcome [1] 390751 0
Perinatal depression severity: Change in scores from baseline on the Edinburgh Postnatal Depression 10-item Scale (EPDS)
Timepoint [1] 390751 0
The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21.

The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post-intervention commencement); at the 3-month follow up (week 21 post intervention assessment); and at the 6-month follow up (week 33 post-intervention commencement).
Secondary outcome [2] 390753 0
Grief intensity: Change in scores from baseline on the Perinatal Grief Scale - 33-item Short Form (PGS-SF)
Timepoint [2] 390753 0
The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21.

The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post-intervention commencement); at the 3-month follow up (week 21 post intervention assessment); and at the 6-month follow up (week 33 post-intervention commencement).
Secondary outcome [3] 390755 0
Anxiety severity: Change in scores from baseline on the Generalized Anxiety Disorder 7-item Scale (GAD-7)
Timepoint [3] 390755 0
The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21.

The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post-intervention commencement); at the 3-month follow up (week 21 post intervention assessment); and at the 6-month follow up (week 33 post-intervention commencement).
Secondary outcome [4] 390757 0
Extent of distress and remorse after a healthcare decision: Change in scores from baseline on the Decisional Regret 5-item Scale (DRS)
Timepoint [4] 390757 0
The secondary outcome will be assessed in the control group at two timepoints: Week 9 and week 21.

The secondary outcome will be assessed in the intervention group at the following timepoints: 1 week after program completion (week 9 post-intervention commencement); at the 3-month follow up (week 21 post intervention assessment); and at the 6-month follow up (week 33 post-intervention commencement).
Secondary outcome [5] 390806 0
Participants satisfaction of the intervention program on the Module Satisfaction Scale (MSS)
Timepoint [5] 390806 0
Once weekly during the eight-week active study period (Weeks 1-8).
Secondary outcome [6] 390807 0
Participants satisfaction of the intervention program on the Program Satisfaction Questionnaire (PSQ)
Timepoint [6] 390807 0
Post-intervention (Week 9 post intervention commencement).
Secondary outcome [7] 390808 0
Health-related quality of life: Change in scores from baseline on the Assessment of Quality of Life 35-item Scale (AQoL-8D)
Timepoint [7] 390808 0
The secondary outcome will be assessed in the control and intervention group at week 9 (9 weeks post intervention commencement) and at the 3-month follow up (21 weeks post intervention commencement).
Secondary outcome [8] 390809 0
Participant health service utilisation on the Health Service Utilisation 23-item Scale (HSUS)
Timepoint [8] 390809 0
The secondary outcome will be assessed in the control and intervention group at week 9 (9 weeks post intervention commencement) and at the 3-month follow up (21 weeks post intervention commencement).
Secondary outcome [9] 394366 0
Brief Grief Questionnaire (BGQ)- 5 item self-report assessment of grief symptomology
Timepoint [9] 394366 0
The secondary outcome will be assessed in the intervention group at the 6-month follow up (week 33 post-intervention commencement).

Eligibility
Key inclusion criteria
Parents who have experienced a stillbirth or neonatal death in the last 2 years, and:
- Aged 18 years or older;
- Experienced a stillbirth or neonatal death within the past two years;
- Reside in Australia;
- Oral and written fluency in English language;
- Reliable access to a computer with internet connection;
- Willing to provide informed consent online.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will be determined at the online application page. Applicants will be excluded if they meet any of the following criteria:
1) Currently pregnant;
2) Experienced a stillbirth or neonatal death less than eight weeks ago;
3) Diagnosis of psychosis, bipolar disorder, or schizophrenia within the last two years;
4) Experiencing severe symptoms of psychological distress, depression, or suicidality.

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)
The allocation sequence will be generated by an independent statistician and uploaded to the online course delivery system by an independent person to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to Group 1 (intervention group who will receive access to the online program immediately) or Group 2 (usual care control group who will not access the online program during the eight-week active study period). Randomisation will occur online during the application phase of the trial and once baseline questionnaires have been completed.

Randomisation will be stratified by gender (male; female) and risk category (high; low) variables at baseline. All parents that are accepted into the study will be categorised into low-risk or high-risk groups for the duration of the study. This will be based on symptom severity criteria for psychological distress (K10) completed during the application phase.
• Low-risk: All applicants that report low psychological distress (a total score ranging from 10-24) will be classified as low-risk;
• High-risk: All applicants that report moderate to severe psychological distress (a total score of 25 and higher) will be classified as high-risk.

Participants will be randomised based on a 1:1 ratio between Group 1 (intervention group) and Group 2 (usual care control group) using random permuted block randomisation with block sizes of 2, 4, and 6 to ensure equal numbers of participants in each study arm.
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
Sample size calculation: To detect a moderate effect size (standardized difference /Cohen’s d = 0.50) over three assessment time-points (pre-, post-, 3-month follow-up) – assuming a significance level of 0.05, power of 80%, moderately strong within-subject correlation (rho=0.5) and an anticipated dropout rate of approximately 25% – the minimum sample size required is 150 participants.

Analysis Plan: Analyses will be undertaken using intention to treat mixed model and linear analyses. Planned contrasts will be used to compare changes for each outcome variable within and between groups from baseline to post-treatment, and 1-month and 3-month follow-ups. Between-group effect sizes will be calculated using pooled standard deviation of the estimated marginal means and adjusted for sample size (Hedges g). Descriptive statistics will be used to summarise participant engagement, adherence and program satisfaction data.

Health economic evaluation will be undertaken on an intention-to-treat basis with differences in costs between the intervention and treatment as usual (TAU) groups calculated on a cost-per-case basis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
28/06/2021
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
150
Accrual to date
86
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 18476 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 32794 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 307589 0
Other Collaborative groups
Name [1] 307589 0
Health Translation Queensland
Country [1] 307589 0
Australia
Primary sponsor type
Other
Name
Mater Research Institute - The University of Queensland
Address
Raymond Terrace
Level 3, Aubigny Place
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 308328 0
None
Name [1] 308328 0
Address [1] 308328 0
Country [1] 308328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307644 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 307644 0
Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Ethics committee country [1] 307644 0
Australia
Date submitted for ethics approval [1] 307644 0
02/11/2020
Approval date [1] 307644 0
17/12/2020
Ethics approval number [1] 307644 0
HREC/MML/70343

Summary
Brief summary
Improving perinatal bereavement care after the loss of a baby is an urgent priority in Australia, and accessible perinatal bereavement care approaches that include early psychological support are required, Internet-based programs offer one solution to address this gap, particularly for primary care settings and those parents in rural Australian communities.
The primary purpose of this trial is to evaluate the acceptability and efficacy of a new internet-delivered cognitive behaviour therapy (iCBT) support program in reducing emotional distress for parents who have experienced a stillbirth or neonatal death, compared with usual care.
We hypothesise that participants who complete the online program “Living with Loss” will experience greater improvements in psychological distress and psychosocial health and wellbeing outcomes (e.g. anxiety, depression, decisional regret etc) than those in the usual care control group.
It is also hypothesised that the Living with Loss” will be acceptable to participants with high rates of program satisfaction reported, and will be more cost-effective in improving psychosocial health and wellbeing outcomes than usual care alone.
Trial website
https://stillbirthcre.org.au/parents/care-after-loss/living-with-loss/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107982 0
Dr Dr Siobhan Loughnan
Address 107982 0
NHMRC Centre of Research Excellence in Stillbirth (Stillbirth CRE), Mater Research Institute - The University of Queensland, Level 3 Aubigny Place, Mater Health Services, South Brisbane, QLD 4101
Country 107982 0
Australia
Phone 107982 0
+61 7 3163 8027
Fax 107982 0
Email 107982 0
siobhan.loughnan@mater,uq.edu.au
Contact person for public queries
Name 107983 0
Dr Siobhan Loughnan
Address 107983 0
NHMRC Centre of Research Excellence in Stillbirth (Stillbirth CRE), Mater Research Institute - The University of Queensland, Level 3 Aubigny Place, Mater Health Services, South Brisbane, QLD 4101
Country 107983 0
Australia
Phone 107983 0
+61 7 3163 8027
Fax 107983 0
Email 107983 0
siobhan.loughnan@mater.uq.edu.au
Contact person for scientific queries
Name 107984 0
Dr Siobhan Loughnan
Address 107984 0
NHMRC Centre of Research Excellence in Stillbirth (Stillbirth CRE), Mater Research Institute - The University of Queensland, Level 3 Aubigny Place, Mater Health Services, South Brisbane, QLD 4101
Country 107984 0
Australia
Phone 107984 0
+61 7 3163 8027
Fax 107984 0
Email 107984 0
siobhan.loughnan@mater.uq.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
Privacy of participant data as stated in original consent form.


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
SourceTitleYear of PublicationDOI
EmbaseLiving with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death.2022https://dx.doi.org/10.1186/s13063-022-06363-0
N.B. These documents automatically identified may not have been verified by the study sponsor.