Pragmatic RCT to Assess the Effectiveness of an Online Self-help Programme for Older Adults After Spousal Bereavement

Summary

Introduction: The death of a partner is a frequent and very stressful critical life event in later life. Grief and psychological distress after the loss of a partner are normative reactions. However, 10% of individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief, or adaptation problems. Focus groups have concluded that Portuguese older adults who lost their partner avoid and downplay the grief process, not seeking help when needed. LEAVES is an interactive self-help online 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. As part of an international consortium with two more trial centres, LEAVES-PT will carry out a 10-week pragmatic randomised two-armed parallel-group controlled trial to determine the effectiveness of LEAVES vs. usual care in reducing grief in community-dwelling Portuguese adults over 55 years who have lost a partner. Besides the clinical evaluation, a cost-effectiveness analysis will be carried out.

Methods: Adults over 55 years, who have lost a partner and are registered with a primary care service in Lower Alentejo, Portugal will be invited to participate and, after screening for eligibility, a minimum of 100 will be randomised to one of two arms: usual care + LEAVES online service or usual care (1:1). The intervention will last for 10 weeks and follow-up will last for a further 10 weeks (20 weeks). Grief is the primary endpoint and it is measured by the Texas Revised Inventory of Grief. Linear mixed models will be used to determine the effectiveness of LEAVES on grief symptoms using the intention-to-treat principle. Due to several recruitment barriers the study ultimately became a pre-post study with only 1 intervention arm.

Conditions

• Grief
• Bereavement

Interventions

OTHER

LEAVES

LEAVES consists of 10 modules of readings and exercises. Readings are filled with evidence-based information on grief-related topics (e.g., how to positively influence thoughts, emotions and behaviours), followed by exercises which encourage mourners to actively reflect on what was learned and apply their new knowledge into their grief journey and coping strategies (e.g., how to change attentional focus). Users are encouraged to work through one module per week and complete the assignments.

Sponsors & Collaborators

• Unidade Local de Saúde do Baixo Alentejo

  collaborator UNKNOWN

• Fundação para a Ciência e a Tecnologia

  collaborator OTHER

• European Commission

  collaborator OTHER

• Universidade Nova de Lisboa

  lead OTHER

Principal Investigators

• Ana M Rodrigues, MD · Universidade Nova de Lisboa

• Ana M Pires, MD · Unidade Local de Saúde do Baixo Alentejo

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-27

Primary Completion

2023-01-19

Completion

2023-01-19

Countries

• Portugal

Study Locations