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

NCT06270381 | Recruiting

• 1 other identifier: UIDB/05299/2020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Grief Disorder, Prolonged

Outcome Measures

Primary Outcomes (1)

• Prolonged Grief

  Prolonged Grief Scale - Revised (PG13-R). PG13-R is a self-report scale developed by Prigerson et al., (2021) based on DSM-5-TR criteria for PGD. PG-13-R includes 13 items, evaluated in a 5-point likert scale. PG-13-R grief symptoms represent a unidimensional construct, with high degrees of internal consistency in research conducted at Yale (Cronbach's α = .83), Utrecht (Cronbach's α = .90), and Oxford (Cronbach's α = .93) universities. PGD diagnosis is attributed when the person obtains a total value greater than 30 and meets the temporal (12 months) and impairment criteria.

  pre-first session, last session (up to twelve weeks), follow-up (6 months after the previous assessment)

Secondary Outcomes (1)

• Anxiety and depression

  pre-first session; follow-up (6 months after the previous assessment)

Other Outcomes (8)

• Sociodemographic data

  screening; pre-first session

• Risk Assessment for Grief

  screening

• Coping strategies

  pre-first session

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants that receive EMPOWER intervention

Other: EMPOWER

Arm 2

ACTIVE COMPARATOR

Participants that receive treatment as usual (TAU) intervention

Other: Treatment as usual (TAU)

Interventions

EMPOWER OTHER

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.

Arm 1

Treatment as usual (TAU) OTHER

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.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Unidade Local de Saúde Santa Maria

Lisbon, Portugal

RECRUITING

Related Publications (17)

• 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.

  PMID: 22035996 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16250744 BACKGROUND

• 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.

  PMID: 21443364 BACKGROUND

• 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.

  BACKGROUND

• Ministry of Health. 2017. Te Ara Whakapiri: Principles and guidance for the last days of life. (2nd ed). Wellington: Ministry of Health.

  BACKGROUND

• 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.

  PMID: 25175516 BACKGROUND

• 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.

  PMID: 17365902 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33432758 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 8827649 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34233779 BACKGROUND

MeSH Terms

Conditions

Prolonged Grief Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• David Neto

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Neto, PhD

CONTACT

+351933220520; dneto@ispa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 21, 2024
• Study Start: August 7, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)