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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Portuguese adults aged 60 years or older

Bereaved 1 to 12 months prior to recruitment

Disqualifiers

Recent serious mental illness

Significant cognitive impairment at screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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 3 - Moderated Self-Help Groups (MSHGroups)

    Other intervention

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

Treatment groups

246 Participants
are divided into 3 treatment groups
Group A: Arm 1: Information and Grief Literacy (IGLiteracy)Other 1 intervention
Group B: Arm 2: Individual Self-Help Program (ISelfHP)Other 1 intervention
Group C: Arm 3: Moderated Self-Help Groups (MSHGroups)Other 1 intervention

Trial outcomes

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.

Time frame
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)

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.

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

Other outcomes

1

Sociodemographic and death-related questionnaire

A sociodemographic and death-related questionnaire will assess: (a) social and demographic characteristics; (b) death-related characteristics (e.g., type of death, relationship with the deceased, previous care status); and (c) post-death impacts (e.g., living status, relationship-status change). Engagement and completion of the intervention tasks will also be quantitatively assessed.

Time frame
[Screening]
2

The Prolonged Grief Screening Tool (PGST)

Prolonged Grief Screening Tool (PGST), a 5-item self-report screening instrument developed to identify bereaved adults at elevated risk of developing Prolonged Grief Disorder. Items assess loss-related anger and guilt, perceived closeness to the deceased, concurrent stressfu. Items are rated on a 5-point scale (1 to 5). Total score is calculated as the sum of all items. Score range: 5 to 25. Higher scores indicate greater risk of prolonged grief.

Time frame
At screening (prior to randomization)
3

Grief Relational Needs Scale (GRNS)

Grief Relational Needs Scale (GRNS) is a 11 item self-report, assessing perceived relational support needs in grief across different components (e.g., security, validation, appreciation). The GRNS comprises two subscales: Need for Protection and Validation (9 items) and Need for Mutuality (3 items). Items are rated on a 5-point Likert scale (1 = "nothing" to 5 = "extremely"). Score range: 11 to 55. Higher scores indicate greater unmet relational needs.

Time frame
At screening (prior to randomization).
4

Adult attachment

Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS), adapted to assess attachment to the deceased. Items are rated on a seven-point Likert scale that ranges from 1 (strongly disagree) to 7 (strongly agree). Its 9 items are grouped into 2 dimensions: attachment-related anxiety (items 1-6) and avoidance (items 7-9). Scores for each dimension (attachment anxiety and attachment avoidance) are calculated as the mean of the corresponding items. Higher scores indicate higher attachment avoidance or anxiety. Score range (mean per dimension): 1 to 7.

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

Sponsors and contacts

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