Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder (NCT06270381) | Clinical Trial Compass
UnknownNot Applicable
Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder
Portugal44 participantsStarted 2023-08-07
Plain-language summary
The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prolonged Grief
Timeframe: pre-first session, last session (up to twelve weeks), follow-up (6 months after the previous assessment)
Trial details
NCT IDNCT06270381
SponsorISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida