Menu
Not yet recruiting NCT07433101

Understanding and Responding to Grief-Related Needs: A Differentiated Community Approach

No phase Interventional Prolonged Grief Disorder (PGD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IGLiteracy, Arm 2 - Individual Self-Help Program (ISelfHP), Arm 3 - Moderated Self-Help Groups (MSHGroups).
Who it may be relevant to
Registry conditions: Prolonged Grief Disorder (PGD). Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Responding to Grief-Related Needs: Study Protocol for a Pilot Randomized Controlled Trial

Overview

The GriefDiff study is a randomized controlled trial evaluating a differentiated, community-based model of grief support for older adults. It compares three intervention levels-Information and Grief Literacy (IGLiteracy), Individual Self-Help Program (ISelfHP), and Moderated Self-Help Groups (MSHGroups)-to assess their effectiveness in reducing prolonged grief and psychological distress. Participants are screened for risk of Prolonged Grief Disorder and relational needs, then randomized to matched or non-matched interventions. Outcomes are measured at baseline, post-intervention (3 months), and follow-up (6 months), focusing primarily on prolonged grief symptoms and secondarily on depression, anxiety, stress, attachment, social support, and traumatic stress. The study aims to provide evidence for a cost-effective, scalable, and preventive public health model of bereavement care.

Detailed description

Introduction Grief in later life is a common yet under-recognized public health issue. Although most older adults adapt to bereavement without formal intervention, a significant minority develop Prolonged Grief Disorder (PGD), characterized by persistent yearning, emotional pain, and functional impairment. Older adults are particularly vulnerable due to cumulative losses, declining health, social isolation, and reduced access to psychosocial resources. Despite the documented psychological, physical, and social consequences of adverse grief reactions, prevention and early intervention remain marginal in health and social care systems.

Current responses to grief are often reactive and clinically oriented, focusing primarily on individuals who already present severe symptoms. This approach overlooks a large group of bereaved individuals experiencing substantial distress that does not yet meet diagnostic thresholds and limits opportunities for prevention. Furthermore, most existing interventions are hospital-based and individual-focused, while community-based and scalable approaches remain underdeveloped.

In line with international policy frameworks, including the World Health Organization's stepped-care model for mental health, differentiated models of grief support propose that interventions should be matched to individuals' levels of need. Such models are typically organized as a pyramid, ranging from low-intensity informational support to more structured and specialized interventions. This approach aims to optimize resource allocation, increase accessibility, and promote equity in mental health care.

Aims The primary objective of the GriefDiff study is to implement and evaluate the effectiveness of a differentiated, tiered model of grief intervention in reducing prolonged grief symptoms and psychological distress among older bereaved adults. Specifically, the study compares three intervention levels-IGLiteracy, ISelfHP, and MSHGroups-in terms of their impact on grief outcomes.

A secondary objective is to test the added value of matching interventions to participants' risk levels and relational needs, examining whether matched allocations lead to superior outcomes compared to non-matched conditions. The study also aims to identify predictors of engagement and response to intervention, including attachment patterns, social support, and traumatic stress. Ultimately, this research seeks to inform public health strategies by providing evidence for a cost-effective, community-centred, and preventive model of bereavement care.

Procedures Participants will be recruited through community and health organizations, including a national grief association and partner institutions. Individuals referred by these entities will undergo a screening process assessing eligibility, risk of PGD, and relational needs. Eligible participants will receive detailed information about the study and will provide written informed consent prior to participation.

Data collection will follow strict ethical and confidentiality standards. All data will be anonymized and securely stored. Participants will be informed of their right to withdraw at any time without consequences.

To promote retention and minimize attrition, several strategies will be implemented, including flexible scheduling, regular contact with the research team, reminders for assessment points, and the availability of both digital and non-digital intervention formats. A feedback mechanism will be established to allow participants to share their experiences and concerns throughout the study.

All interventions will be delivered within a community-based framework and will be supported by standardized manuals and materials. Intervention providers will receive specific training and ongoing supervision to ensure fidelity and consistency across conditions.

Trial Design The GriefDiff study is a rater-blinded, randomized controlled trial with three parallel intervention arms. Following baseline assessment, participants will be stratified according to risk of prolonged grief and relational needs and then randomized to one of the three intervention conditions: IGLiteracy, ISelfHP, or MSHGroups.

Randomization will be conducted using block randomization within predefined risk-by-needs strata to ensure balanced allocation across conditions. Allocation concealment will be maintained through the use of a computer-generated random sequence, managed by an independent member of the research team.

Outcome assessors will be blinded to participants' allocation. Participants will be assessed at baseline (T0), post-intervention at three months (T1), and follow-up at six months (T2). In addition to evaluating overall intervention effects, the design allows for the examination of matching effects by comparing outcomes between participants who were allocated to matched versus non-matched intervention conditions. This trial provides a rigorous methodological framework to test a differentiated, community-based model of grief care, with the potential to inform future service organization and policy in bereavement support.

Interventions

  • Behavioral IGLiteracy
    A low-intensity intervention with one group psychoeducation session on grief reactions and available support, followed by bi-weekly SMS reminders for three months. It represents the minimum active support.
  • Behavioral Arm 2 - Individual Self-Help Program (ISelfHP)
    A digital self-help program promoting emotional regulation and adaptive grief processing through psychoeducation and exercises. Participants complete activities over three months, supported by reminders and brief phone contacts. Printed materials are available if needed.
  • Other Arm 3 - Moderated Self-Help Groups (MSHGroups)
    Weekly psychologist-led peer groups for three months, focusing on emotional expression, acceptance, meaning-making, and coping, using a standardized protocol.

Primary outcome measures

  • Prolonged Grief Scale - Revised (PG13-R) [Time frame: Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2).]
Secondary outcome measures (1)
  • Depression, Anxiety and Stress Scales - Short Form (DASS-21) [Time frame: Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2)]

Eligibility criteria

Inclusion criteria

  • Portuguese adults aged 60 years or older
  • Bereaved 1 to 12 months prior to recruitment

Exclusion criteria

  • Recent serious mental illness
  • Significant cognitive impairment at screening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • InLuto Association — Lisbon

Publications

  • Neto DD, Coelho A, Barbosa M, Albuquerque S. Responding to grief-related needs in older adults: protocol for a community-based matched-care trial (GriefDiff). BMC Psychol. 2026 Apr 7;14(1):761. doi: 10.1186/s40359-026-04491-9. PMID 41947269

Identifiers

NCT: NCT07433101 · SR25-00397

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗