Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270381
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-12
Brief Title:
Empower-Grief A Study on a Selective Intervention to Prevent Prolonged Grief Disorder
Sponsor:
ISPA - Instituto Universitario de Ciencias Psicologicas Sociais e da Vida
Organization:
ISPA - Instituto Universitario de Ciencias Psicologicas Sociais e da Vida
Study Overview
Official Title:
Empower-Grief Study Protocol for a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Introduction Grief reactions of relatives of palliative care patients are seldom addressed Most interventions focus on Prolonged Grief Disorder PGD and not on prevention This is particularly relevant in palliative and advanced cancer contexts in which death is the result of a difficult period of a terminal illness making caregivers particularly vulnerable to elevated psychological distress and PGD Also matched care interventions align with World Health Organization WHOs 2009 guidelines for organizing mental health services These guidelines structured in a pyramid fashion ranging from low-intensity selective interventions and widely available to high-intensity specialized interventions are tailored to citizens needs The differentiation of interventions allows combining need-based timely interventions to prevent PGD while increasing accessibility and mitigating inequality through rationalization of service delivery
Aims The present research intends to implement and evaluate the effectiveness of the low-intensity selective intervention EMPOWER compared to usual care in terms of symptoms of prolonged grief and psychological distress in the population of family caregivers who lost a loved one in palliative and advanced cancer contexts The second objective is to identify predictors of response to intervention This research is crucial to influence national policy towards a greater emphasis on prevention and early intervention making the allocation of cost-effective bereavement support services the most efficient and sustainable approach for a significant public health impact in bereavement care
Procedures Family members will be contacted from the Centro Hospitalar Universitário Lisboa Norte by phone following the usual practice of the clinical service Those considered at risk using the cut-off points of risk assessment to be at a moderate level will be invited to additional intervention and participation in the current study All participants will provide informed consent before being allocated to one of the two interventions The informed consent process will cover the studys purpose procedures potential risks and benefits and it will be obtained from each participant before any data collection or randomization occurs Participants will be reassured that their data will be anonymized and securely stored Strategies to enhance participant retention and minimize attrition will be employed including regular check-ins reminders for follow-up assessments a dedicated study coordinator to address participant concerns and flexible scheduling options Also a feedback system for participants to express concerns or provide input on the studys procedures will be put in place and this will be used to make necessary adjustments Throughout their participation we will emphasize participants contribution to improving grief support for others and the rigorous privacy and confidentiality measures in place Treatment will be offered at Centro Hospitalar Universitário Lisboa Norte local health unit Santa Maria to family members of patients followed on the palliative care unit and oncology service To ensure fidelity and quality of intervention delivery across the team the standardized intervention protocol for EMPOWER will be utilized manualized intervention providers will receive standardized training and will have ongoing supervision fidelity assessment tools will be used
Trial design a rater-blinded Randomized Controlled Trial RCT with two parallel groups comparing the EMPOWER and treatment as usual TAU will take place in order to investigate a two-tier psychological intervention program designed to prevent PGD and offer early intervention for grief-related issues Randomization will be independently conducted by a research assistant Participants will be randomly assigned EMPOWER vs TAU Randomization will occur after a participant meets eligibility criteria provides consent and undergoes risk assessment The participants will be allocated to each branch of the RCT through block randomization A random sequence of numbers or allocation codes will be generated using a randomization tool This sequence will determine the allocation of participants to the two intervention groups To maintain allocation concealment the randomization sequence will be securely locked away from researchers involved in recruitment and assessment When a participant is deemed eligible and has provided informed consent an independent staff member or an automated system not involved in day-to-day study operations will access the randomization sequence to assign the participant Throughout the study the project team will continuously monitor the randomization process to ensure it is executed as planned with any deviations documented and addressed
Aims The present research intends to implement and evaluate the effectiveness of the low-intensity selective intervention EMPOWER compared to usual care in terms of symptoms of prolonged grief and psychological distress in the population of family caregivers who lost a loved one in palliative and advanced cancer contexts The second objective is to identify predictors of response to intervention This research is crucial to influence national policy towards a greater emphasis on prevention and early intervention making the allocation of cost-effective bereavement support services the most efficient and sustainable approach for a significant public health impact in bereavement care
Procedures Family members will be contacted from the Centro Hospitalar Universitário Lisboa Norte by phone following the usual practice of the clinical service Those considered at risk using the cut-off points of risk assessment to be at a moderate level will be invited to additional intervention and participation in the current study All participants will provide informed consent before being allocated to one of the two interventions The informed consent process will cover the studys purpose procedures potential risks and benefits and it will be obtained from each participant before any data collection or randomization occurs Participants will be reassured that their data will be anonymized and securely stored Strategies to enhance participant retention and minimize attrition will be employed including regular check-ins reminders for follow-up assessments a dedicated study coordinator to address participant concerns and flexible scheduling options Also a feedback system for participants to express concerns or provide input on the studys procedures will be put in place and this will be used to make necessary adjustments Throughout their participation we will emphasize participants contribution to improving grief support for others and the rigorous privacy and confidentiality measures in place Treatment will be offered at Centro Hospitalar Universitário Lisboa Norte local health unit Santa Maria to family members of patients followed on the palliative care unit and oncology service To ensure fidelity and quality of intervention delivery across the team the standardized intervention protocol for EMPOWER will be utilized manualized intervention providers will receive standardized training and will have ongoing supervision fidelity assessment tools will be used
Trial design a rater-blinded Randomized Controlled Trial RCT with two parallel groups comparing the EMPOWER and treatment as usual TAU will take place in order to investigate a two-tier psychological intervention program designed to prevent PGD and offer early intervention for grief-related issues Randomization will be independently conducted by a research assistant Participants will be randomly assigned EMPOWER vs TAU Randomization will occur after a participant meets eligibility criteria provides consent and undergoes risk assessment The participants will be allocated to each branch of the RCT through block randomization A random sequence of numbers or allocation codes will be generated using a randomization tool This sequence will determine the allocation of participants to the two intervention groups To maintain allocation concealment the randomization sequence will be securely locked away from researchers involved in recruitment and assessment When a participant is deemed eligible and has provided informed consent an independent staff member or an automated system not involved in day-to-day study operations will access the randomization sequence to assign the participant Throughout the study the project team will continuously monitor the randomization process to ensure it is executed as planned with any deviations documented and addressed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None