None listed
Conditions
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.
Interventions
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, an
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).
Sponsors
Mater Research Institute - The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed