Study Protocol for a 10-week Pragmatic Two-arm Randomised Controlled Trial to Assess the Effectiveness of LEAVES (an Internet-based Self-help Programme for Older Adults After Spousal Bereavement)

Introduction:

Theoretical background:

The death of a partner is a frequent and very stressful critical life event in later life. It implies a dissolution of social and emotional ties. This deeply affects the attachment system, requires the acceptance of the loss, as well as the formation of a new identity and a new perspective for the future. It involves the adaptation of daily routines which can be even more challenging when social, physical, and financial resources decline in later life. Grief and psychological distress after the loss of a partner are normative reactions. For most people, grief intensity weakens to a manageable degree within several weeks or months. After the most intensive period, grief is still present, but the loss becomes gradually integrated and no longer hinders the way of ongoing life. However, some individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief, or adaptation problems. About 10% of older adults develop a prolonged grief disorder or persistent complex bereavement disorder, characterised by separation distress, frequent or disabling cognitive, emotional and behavioural symptoms, such as avoidance of reminders of the loved one, difficulties moving on with life and functional impairment. The development of prolonged grief or adaptation problems often goes unnoticed by the widow(er) who then fail to realize that help may be needed. This leads to a situation in which older adults are unaware of their own needs, do not seek help, and do not receive the care needed. Previous focus groups and stakeholder's feedback have noted that Portuguese older adults who lost their partner (and their family members) avoid and downplay the grief process, not seeking help when needed. This may lead to a high usage of primary care and, later on, to mental health services, with complaints of insomnia, physical and depressive symptoms.

A wide range of interventions are available for either preventing or treating prolonged grief disorder including support groups, writing exercises, and individual psychological counselling, and, more recently, internet-based options. Such interventions mostly consist of writing exercises with minimal therapist involvement. Previously, Brodbeck and colleagues found that a 12-week intervention with a bereavement online support service (LIVIA) in Swiss adults 40+ years old had a medium to large effect on grief, depression and loneliness over 3 months as well as increasing life satisfaction.

Adapted from LIVIA and combining features from the "Before you leave" app, LEAVES is an online self-help interactive programme founded in the task model of mourning and the dual-process model of coping with bereavement that supports older adults who have lost their partner in dealing with and preventing prolonged grief following a user-centred, iterative and agile approach. In LEAVES-PT the investigators will carry out a 10-week pragmatic randomised two-armed parallel-group controlled trial to compare the effectiveness of LEAVES vs. usual care in reducing grief in community-dwelling Portuguese adults over 55 years registered with the local primary care unit. Besides the clinical evaluation, a qualitative study of implementation and engagement with the LEAVES online service and a cost-effectiveness analysis will be carried out. This trial (LEAVES-PT) is part of a larger study from an international consortium (LEAVES) with two more trial centres but with distinct design and methodology (The Netherlands and Switzerland).