A program to prevent prolonged grief disorder in bereaved individuals
Empower-Grief: Study Protocol for a Pilot Randomized Controlled Trial
This study is testing a new program called EMPOWER to see if it can help family caregivers who have lost a loved one avoid prolonged grief disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida Academic / other |
| Locations | 1 site (Lisboa) |
| Trial ID | NCT06270381 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a selective intervention called EMPOWER, designed to prevent prolonged grief disorder (PGD) among family caregivers who have lost a loved one in palliative and oncological contexts. Participants will be randomly assigned to receive either the EMPOWER intervention or Treatment as Usual (TAU), with assessments conducted at multiple time points to measure symptoms of PGD, anxiety, depression, and other psychological factors. The study aims to identify predictors of adherence and efficacy, contributing to a greater emphasis on prevention and early intervention in mental health services.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have lost a close person in a palliative or oncological context within the last 12 months.
Not a fit: Patients with pre-existing severe mental disorders or those at risk of suicide may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of prolonged grief disorder among bereaved individuals.
How similar studies have performed: Other studies have shown promise in using cognitive-behavioral interventions for grief, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having more than 18 years old * Having experienced the death of a close person (i.e., relative, partner, friend) in the palliative and oncological context * Having sufficient cognitive abilities and proficiency in the Portuguese language * Participants will be considered if the death has occurred up to 12 months, considering that the time criterion in diagnosis for prolonged grief disorder is 12 months (and the focus in this study is on prevention) Exclusion Criteria: * individuals with a pre-existing severe or active mental disorder predating the loss (e.g., schizophrenia, bipolar disorder, major depression) * individuals with suicide risk assessed during the intervention * individuals undergoing other psychological interventions before the loss of the loved one
Where this trial is running
Lisboa
- Unidade Local de Saúde Santa Maria — Lisboa, Portugal (Recruiting)
Study contacts
- Principal investigator: David Neto — ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Study coordinator: David Neto, PhD
- Email: dneto@ispa.pt
- Phone: +351933220520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.