Clinical trial NCT06270381: Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder
Official title: Empower-Grief: Study Protocol for a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Grief Disorder, Prolonged
Lead sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (WHO)'s (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 study's 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 study's 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.

Eligibility 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

Primary outcomes:
measure: Prolonged Grief
timeFrame: pre-first session, last session (up to twelve weeks), follow-up (6 months after the previous assessment)
Secondary outcomes:
measure: Anxiety and depression
timeFrame: pre-first session; follow-up (6 months after the previous assessment)
Other outcomes:
measure: Sociodemographic data
timeFrame: screening; pre-first session
measure: Risk Assessment for Grief
timeFrame: screening
measure: Coping strategies
timeFrame: pre-first session
measure: Adult attachment
timeFrame: pre-first session
measure: Psychological inflexibility
timeFrame: pre-first session
measure: Social Support
timeFrame: pre-first session
measure: Therapeutic alliance
timeFrame: last session (up to twelve weeks)
measure: Posttraumatic Growth
timeFrame: follow-up (6 months after the previous assessment)
Locations:
city: Lisboa
country: Portugal
facility: Unidade Local de Saúde Santa Maria
Study officials:
affiliation: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
name: David Neto
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
citation: Carvalho, S., Pinto-Gouveia, J., Pimentel, P., Maia, D., & Mota-Pereira, J. (2011). Características psicométricas da versão portuguesa da escala multidimensional de suporte social percebido (multidimensional scale of perceived social support-mspss). Psychologica, 54, 331-357.
citation: Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
citation: Fraley RC, Heffernan ME, Vicary AM, Brumbaugh CC. The Experiences in Close Relationships-Relationship Structures questionnaire: a method for assessing attachment orientations across relationships. Psychol Assess. 2011 Sep;23(3):615-25. doi: 10.1037/a0022898.
citation: Machado P. P., Horvath A. (1999). Inventário da aliança terapêutica (WAI). In Simões M.R., Gonçalves M. M., Almeida L. S. (Eds.), Testes e provas psicológicas em Portugal (Vol. 2, pp. 87-94). Braga, AP-PORT/SHO.
citation: Ministry of Health. 2017. Te Ara Whakapiri: Principles and guidance for the last days of life. (2nd ed). Wellington: Ministry of Health.
citation: Moreira H, Martins T, Gouveia MJ, Canavarro MC. Assessing adult attachment across different contexts: validation of the Portuguese version of the experiences in Close Relationships-Relationship Structures questionnaire. J Pers Assess. 2015;97(1):22-30. doi: 10.1080/00223891.2014.950377. Epub 2014 Aug 30.
citation: Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.
citation: Pinto-Gouveia, J., Gregório, S., Dinis, A., & Xavier, A. (2012). Experiential avoidance in clinical and non-clinical samples: AAQ-II Portuguese version. International Journal of Psychology and Psychological Therapy, 12(2), 139-156.
citation: Prigerson HG, Boelen PA, Xu J, Smith KV, Maciejewski PK. Validation of the new DSM-5-TR criteria for prolonged grief disorder and the PG-13-Revised (PG-13-R) scale. World Psychiatry. 2021 Feb;20(1):96-106. doi: 10.1002/wps.20823.
citation: Ribeiro, J. L. P., & Rodrigues, A. P. (2004). Questões acerca do coping: A propósito do estudo de adaptação do Brief Cope. Psicologia, Saúde e Doenças, (1), 3-15.
citation: Silva, S., Moreira, H., Pinto, S., & Canavarro, M. C. (2009). Cancro da mama e desenvolvimento pessoal e relacional: Estudo das características psicométricas do Inventário de Desenvolvimento Pós-Traumático (Posttraumatic Growth Inventory) numa amostra de mulheres da população portuguesa. Revista Iberoamericana de Diagnóstico e Avaliação Psicológica, 28(2), 105-133.
citation: Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2
citation: Tracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology, 1(3), 207-210. https://doi.org/10.1037/1040-3590.1.3.207
citation: Lichtenthal WG, Viola M, Rogers M, Roberts KE, Lief L, Cox CE, Brewin CR, Xu JC, Maciejewski PK, Pan CX, Coats T, Ouyang DJ, Rabin S, Vaughan SC, Breitbart W, Marenberg ME, Prigerson HG. Development and preliminary evaluation of EMPOWER for surrogate decision-makers of critically ill patients. Palliat Support Care. 2022 Apr;20(2):167-177. doi: 10.1017/S1478951521000626.