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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]

None

Universal Trial Number (UTN)

Trial acronym

LWL RCT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

psychological distress

stillbirth

grief

depression

perinatal loss

neonatal death

bereavement

Condition category

Condition code

Mental Health

Depression

Reproductive Health and Childbirth

Complications of newborn

Reproductive Health and Childbirth

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]

Behaviour

Intervention code [2]

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]

Psychological distress severity: Changes in score from baseline on the Kessler Psychological Distress 10-item Scale (K10)

Timepoint [1]

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]

Perinatal depression severity: Change in scores from baseline on the Edinburgh Postnatal Depression 10-item Scale (EPDS)

Timepoint [1]

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]

Grief intensity: Change in scores from baseline on the Perinatal Grief Scale - 33-item Short Form (PGS-SF)

Timepoint [2]

Secondary outcome [3]

Anxiety severity: Change in scores from baseline on the Generalized Anxiety Disorder 7-item Scale (GAD-7)

Timepoint [3]

Secondary outcome [4]

Extent of distress and remorse after a healthcare decision: Change in scores from baseline on the Decisional Regret 5-item Scale (DRS)

Timepoint [4]

Secondary outcome [5]

Participants satisfaction of the intervention program on the Module Satisfaction Scale (MSS)

Timepoint [5]

Once weekly during the eight-week active study period (Weeks 1-8).

Secondary outcome [6]

Participants satisfaction of the intervention program on the Program Satisfaction Questionnaire (PSQ)

Timepoint [6]

Post-intervention (Week 9 post intervention commencement).

Secondary outcome [7]

Health-related quality of life: Change in scores from baseline on the Assessment of Quality of Life 35-item Scale (AQoL-8D)

Timepoint [7]

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]

Participant health service utilisation on the Health Service Utilisation 23-item Scale (HSUS)

Timepoint [8]

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]

Brief Grief Questionnaire (BGQ)- 5 item self-report assessment of grief symptomology

Timepoint [9]

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

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Health Translation Queensland

Address [1]

Princess Alexandra Hospital Campus
R Wing Level 5
199 Ipswich Rd
Woolloongabba Qld 4102

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Misericordiae Ltd Human Research Ethics Committee

Ethics committee address [1]

Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2020

Approval date [1]

17/12/2020

Ethics approval number [1]

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

Dr Dr Siobhan Loughnan

Address

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

Australia

Phone

+61 7 3163 8027

Fax

siobhan.loughnan@mater,uq.edu.au

Contact person for public queries

Name

Siobhan Loughnan

Address

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

Australia

Phone

+61 7 3163 8027

Fax

[email protected]

Contact person for scientific queries

Name

Siobhan Loughnan

Address

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

Australia

Phone

+61 7 3163 8027

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Living with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death.	2022	https://dx.doi.org/10.1186/s13063-022-06363-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically