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

NCT07433101 | Not Yet Recruiting

• 1 other identifier: SR25-00397
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolonged Grief Disorder (PGD)

Keywords

Prolonged grief disorder; Bereavement; Older adults; Tiered intervention; Community-based care; Self-help; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Prolonged Grief Scale - Revised (PG13-R)

  The PG-13-R is a 13-item self-report measure assessing Prolonged Grief Disorder symptoms according to DSM-5-TR criteria. Items are rated on a 5-point Likert scale (1 = not at all to 5 = several times a day/overwhelmingly).Total scores are calculated as the sum of all items. Total score range: 13-65. Higher scores indicate greater severity of prolonged grief symptoms. Diagnostic criteria include symptom duration (≥12 months) and functional impairment.

  Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2).

Secondary Outcomes (1)

• Depression, Anxiety and Stress Scales - Short Form (DASS-21)

  Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2)

Other Outcomes (6)

• Sociodemographic and death-related questionnaire

  [Screening]

• The Prolonged Grief Screening Tool (PGST)

  At screening (prior to randomization)

• Grief Relational Needs Scale (GRNS)

  At screening (prior to randomization).

Study Arms (3)

Arm 1: Information and Grief Literacy (IGLiteracy)

OTHER

Assigned Intervention: Information and Grief Literacy Participants allocated to this arm will receive a low-intensity informational intervention aimed at enhancing grief literacy and normalizing the bereavement experience. IGLiteracy consists of a single group session (delivered online or in person) focused on psychoeducation about common and uncommon grief reactions, the grieving process, and available resources for support. Following the session, participants will receive bi-weekly brief reminders (via SMS or equivalent) over a three-month period, reinforcing key concepts and providing practical information and self-care suggestions. This arm represents the minimum active intervention and serves as a universal, low-intensity support condition.

Behavioral: IGLiteracy

Arm 2: Individual Self-Help Program (ISelfHP)

OTHER

Assigned Intervention: Individual Self-Help Program Participants allocated to this arm will receive a structured, low-intensity psychological self-help intervention delivered through a digital WebApp designed for older adults. The ISelfHP aims to promote emotional regulation, psychological well-being, and adaptive grief processing. The intervention includes three main components: 1. psychoeducation about grief and emotional processes; 2. emotional regulation and well-being promotion; 3. grief elaboration and acceptance-based exercises. Participants are encouraged to complete at least one activity per week over a three-month period, although no fixed sequence or minimum dosage is imposed, allowing flexibility according to individual needs and preferences. Engagement is supported through automated reminders and brief motivational contacts by phone from the research team. Participants with low digital literacy - a non-digital alternative (printed materials with equivalent content)

Behavioral: Arm 2 - Individual Self-Help Program (ISelfHP)

Arm 3: Moderated Self-Help Groups (MSHGroups)

OTHER

Assigned Intervention: Moderated Self-Help Groups Participants allocated to this arm will take part in a manualized group-based intervention facilitated by a trained psychologist. MSHGroups are semi-structured peer support groups aimed at fostering shared understanding, emotional expression, and social connection in grief. The intervention consists of weekly group sessions over a three-month period. Each session addresses key themes related to the grief process, including emotional regulation, acceptance, guilt, meaning-making, and coping strategies. Sessions are designed to last approximately three hours and follow a standardized protocol to ensure consistency across groups. The final session focuses on relapse prevention and the promotion of ongoing adaptive coping. Attendance and participant feedback will be systematically recorded. Group facilitators will receive specific training and ongoing supervision to ensure fidelity to the intervention model.

Other: Arm 3 - Moderated Self-Help Groups (MSHGroups)

Interventions

IGLiteracy BEHAVIORAL

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.

Arm 1: Information and Grief Literacy (IGLiteracy)

Arm 2 - Individual Self-Help Program (ISelfHP) BEHAVIORAL

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.

Arm 2: Individual Self-Help Program (ISelfHP)

Arm 3 - Moderated Self-Help Groups (MSHGroups) OTHER

Weekly psychologist-led peer groups for three months, focusing on emotional expression, acceptance, meaning-making, and coping, using a standardized protocol.

Arm 3: Moderated Self-Help Groups (MSHGroups)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recent serious mental illness
• Significant cognitive impairment at screening

Sponsors & Collaborators

• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: lead

Study Sites (1)

InLuto Association

Lisbon, Portugal

Location

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

David Neto, PhD

CONTACT

+351933220520; dneto@ispa.pt

David Neto, PhD

CONTACT

dneto@ispa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1 - Information and Grief Literacy (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. 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. 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. Matching Logic (GriefDiff): Low-risk participants receive IGLiteracy; moderate/high-risk with low relational needs receive ISelfHP; moderate/high-risk with high relational needs receive MSHGroups. Randomization

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)