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Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder

NCT06270381 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

  • Grief Disorder, Prolonged

Interventions

OTHER

EMPOWER

The EMPOWER intervention (Enhancing and Mobilizing the POtential for Wellness and Emotional Resilience) is a cognitive-behavioral and acceptance-based intervention divided into six modules.In the current application, this intervention is conducted in 6 in-presence or online 50-minute sessions and 2 booster sessions 2 and 4 weeks after the final intervention. It is a manualized treatment in which each session has a specific goal: 1st) Welcome, initial assessment and adherence to the intervention; 2nd) Psychoeducation and transmission of resources for stabilization; 3rd) Psychoeducation on Trauma, Grief and Cognitive-Behavioral Model; 4th)Promoting Experiential Acceptance; 5th) Imagined dialogue; 6th) Coping Training; and two final boosting sessions. In every session, the impact of the previous consultation and evolution is evaluated. This intervention was developed by Lichtenthal et al., 2022.

OTHER

Treatment as usual (TAU)

The treatment as usual (TAU) consists of supportive psychotherapy based on a non-structured and integrative method that focuses on the development of more adaptive coping strategies, understanding and working on the patient's internal models of self, others, and the world. The TAU will be considered during the same period as the EMPOWER intervention.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • David Neto · ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270381 on ClinicalTrials.gov