Evaluation of the "Living with Loss" program: An online perinatal bereavement program for psychological distress and emotional wellbeing of parents following perinatal loss.

INTERVENTION: 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 d CONDITION: Mental Health ‐ Depression psychological distress;stillbirth;grief;depression;perinatal loss;neonatal death ;bereavement; ; psychological distress ; stillbirth ; grief ; depression ; perinatal loss ; neonatal death; ; bereavement Reproductive Health and Childbirth ‐ Complications of newborn Reproductive Health and Childbirth ‐ Fetal medicine and complications of pregnancy PRIMARY OUTCOME: Psychological distress severity: Changes in score from baseline on the Kessler Psychological Distress 10‐item Scale (K10)[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: Anxiety severity: Change in scores from baseline on the Generalized Anxiety Disorder 7‐item Scale (GAD‐7)[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).] Brief Grief Questionnaire (BGQ)‐ 5 item self‐report assessment of grief symptomology[The secondary outcome will be assessed in the intervention group at the 6‐month follow up (week 33 post‐intervention commencement).] Extent of distress and remorse after a healthcare decision: Change in scores from baseline on the Decisional Regret 5‐item Scale (DRS)[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).] Grief intensity: Change in scores from baseline on the Perinatal Grief Scale ‐ 33‐item Short Form (PGS‐SF) ; [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).] Health‐related quality of life: Change in scores from baseline on the Assessment of Quality of Life 35‐item Scale (AQoL‐8D) [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).] Participant health service utilisation on the Health Service Utilisation 23‐item Scale (HSUS)[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).] Participants satisfaction of the intervention program on the Module Satisfaction Scale (MSS)[Once weekly during the eight‐week active study period (Weeks 1‐8).] Participants satisfaction of the intervention program on the Program Satisfaction Questionnaire (PSQ)[Post‐intervention (Week 9 post intervention commencement).] Perinatal depression severity: Change in scores from baseline on the Edinburgh Postnatal Depression 10‐item Scale (EPDS)[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).] 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.