AzTrials
AzTrials

Prolonged Grief Disorder (PGD)GriefDiffNCT07433101

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

A study testing IGLiteracy, Arm 2 - Individual Self-Help Program (ISelfHP) and Arm 3 - Moderated Self-Help Groups (MSHGroups) in people with Prolonged Grief Disorder (PGD), run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Prolonged Grief Disorder (PGD)
What is being tested?
IGLiteracy, Arm 2 - Individual Self-Help Program (ISelfHP) and Arm 3 - Moderated Self-Help Groups (MSHGroups)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 sitePortugal
Study dates
1 Mar 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Recent serious mental illness
  • Significant cognitive impairment at screening

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Neto, PhD contact

+351933220520

dneto@ispa.pt

David Neto, PhD contact

dneto@ispa.pt

Portugal1 site
  • InLuto Association

    Lisbon

    Alexandra Coelho, PhD, +351919957534, alexandra.moura.coelho@gmail.com

Other trials in Portugal

About this study

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

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.

Read the 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.

Being tested
IGLiteracy, Arm 2 - Individual Self-Help Program (ISelfHP), Arm 3 - Moderated Self-Help Groups (MSHGroups)
Keywords
Prolonged grief disorder, Bereavement, Older adults, Tiered intervention, Community-based care, Self-help, Randomized controlled trial
Medical subject headings
Prolonged Grief Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IGLiteracyBehavioural

    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)Behavioural

    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)Other

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

Study groups in NCT07433101
Study groupRoleWhat they receive
Arm 1: Information and Grief Literacy (IGLiteracy)OtherAssigned 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.
Receives: Behavioral: IGLiteracy
Arm 2: Individual Self-Help Program (ISelfHP)OtherAssigned 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)
Receives: Behavioral: Arm 2 - Individual Self-Help Program (ISelfHP)
Arm 3: Moderated Self-Help Groups (MSHGroups)OtherAssigned 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.
Receives: Other: Arm 3 - Moderated Self-Help Groups (MSHGroups)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Depression, Anxiety and Stress Scales - Short Form (DASS-21)

    The DASS-21 is a 21-item self-report questionnaire assessing depression, anxiety, and stress symptoms over the previous week. Each item is rated on a 4-point Likert scale (0 = did not apply to me at all; 3 = applied to me very much or most of the time). The measure consists of three subscales (Depression, Anxiety, and Stress), each comprising 7 items rated on a 4-point scale (0 to 3). Subscale scores are calculated as the sum of the 7 corresponding items.

    Score range (per subscale): 0 to 21. Higher scores indicate greater symptom severity in the respective domain.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Participant
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07433101
Sponsor's protocol ID
SR25-00397
Acronym
GriefDiff
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41947269

Questions about this trial

What is this clinical trial studying?

A study testing IGLiteracy, Arm 2 - Individual Self-Help Program (ISelfHP) and Arm 3 - Moderated Self-Help Groups (MSHGroups) in people with Prolonged Grief Disorder (PGD), run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Neto, PhD (+351933220520, dneto@ispa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prolonged Grief Scale - Revised (PG13-R) (time frame: Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07433101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in