Grief Disorder, ProlongedNCT06270381
Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder
A study testing EMPOWER and Treatment as usual (TAU) in people with Grief Disorder, Prolonged, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief Disorder, Prolonged
- What is being tested?
- EMPOWER and Treatment as usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Aug 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde Santa Maria
Lisbon
Alexandra Coelho, PhD, 919957534, alexandra.moura.coelho@gmail.com
About this study
Official title: Empower-Grief: Study Protocol for a Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Grief Disorder, Prolonged
- Being tested
- EMPOWER, Treatment as usual (TAU)
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWEROther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants that receive EMPOWER intervention Receives: Other: EMPOWER |
| Arm 2 | Active comparator | Participants that receive treatment as usual (TAU) intervention Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-first session, last session (up to twelve weeks), follow-up (6 months after the previous assessment)
Secondary outcomes (1)
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS). The HADS measures anxiety and depression symptoms. The scale was developed for non-psychiatric populations (Zigmond \& Snaith, 1983). It includes 14 items, evaluated in a 4-point (0-3) likert scale. Values higher than eight in each subscale are suggestive of clinically relevant symptomatology. In a Portuguese sample (Pais-Ribeiro et al., 2007), Cronbach alpha values were .76 in anxiety and .81 in depression.
Measured: pre-first session; follow-up (6 months after the previous assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start7 Aug 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Grief Disorder, ProlongedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David#Neto, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Investigators
- David Neto, Principal investigator, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270381
- Sponsor's protocol ID
- UIDB/05299/2020
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22035996Carvalho, 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.
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.
PubMed 16250744Fraley 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.
PubMed 21443364Machado 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.
Ministry of Health. 2017. Te Ara Whakapiri: Principles and guidance for the last days of life. (2nd ed). Wellington: Ministry of Health.
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.
PubMed 25175516Pais-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.
PubMed 17365902Pinto-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.
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.
PubMed 33432758Ribeiro, 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.
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.
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.
PubMed 8827649Zigmond 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.
PubMed 6880820Zimet, 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower-Grief: Study Protocol for a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06270381
- Acronym / sponsor ID
- UIDB/05299/2020
- Conditions
- Grief Disorder, Prolonged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da VidaUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: EMPOWERParticipants that receive EMPOWER intervention |
| Arm 2 | Active comparator | Other: Treatment as usual (TAU)Participants that receive treatment as usual (TAU) intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWERThe 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 | Arm 1 |
| 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. | Other | Arm 2 |
Primary outcome
Prolonged Grief
Time frame: pre-first session, last session (up to twelve weeks), follow-up (6 months after the previous assessment)
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.
1 secondary outcome
Anxiety and depression
Time frame: pre-first session; follow-up (6 months after the previous assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 22035996Bond 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.
- BackgroundCarvalho, 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: PubMed 16250744Carver 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.
- Background: PubMed 21443364Fraley 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.
- BackgroundMachado 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.
- BackgroundMinistry of Health. 2017. Te Ara Whakapiri: Principles and guidance for the last days of life. (2nd ed). Wellington: Ministry of Health.
- Background: PubMed 25175516Moreira 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.
- Background: PubMed 17365902Pais-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.
- BackgroundPinto-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: PubMed 33432758Prigerson 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.
- BackgroundRibeiro, 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.
- BackgroundSilva, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Neto principal investigator
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER and Treatment as usual (TAU) in people with Grief Disorder, Prolonged, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Neto, PhD (+351933220520, dneto@ispa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Grief (time frame: pre-first session, last session (up to twelve weeks), follow-up (6 months after the previous assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270381, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.