Pragmatic RCT to Assess the Effectiveness of an Online Self-help Programme for Older Adults After Spousal Bereavement

NCT05156346 | Completed

• 1 other identifier: LEAVES-PT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The death of a partner is a frequent and very stressful critical life event in later life. Grief and psychological distress after the loss of a partner are normative reactions. However, 10% of individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief, or adaptation problems. Focus groups have concluded that Portuguese older adults who lost their partner avoid and downplay the grief process, not seeking help when needed. LEAVES is an interactive self-help online programme founded in the task model of mourning and the dual-process model of coping with bereavement that supports older adults who have lost their partner in dealing with and preventing prolonged grief. As part of an international consortium with two more trial centres, LEAVES-PT will carry out a 10-week pragmatic randomised two-armed parallel-group controlled trial to determine the effectiveness of LEAVES vs. usual care in reducing grief in community-dwelling Portuguese adults over 55 years who have lost a partner. Besides the clinical evaluation, a cost-effectiveness analysis will be carried out. Methods: Adults over 55 years, who have lost a partner and are registered with a primary care service in Lower Alentejo, Portugal will be invited to participate and, after screening for eligibility, a minimum of 100 will be randomised to one of two arms: usual care + LEAVES online service or usual care (1:1). The intervention will last for 10 weeks and follow-up will last for a further 10 weeks (20 weeks). Grief is the primary endpoint and it is measured by the Texas Revised Inventory of Grief. Linear mixed models will be used to determine the effectiveness of LEAVES on grief symptoms using the intention-to-treat principle. Due to several recruitment barriers the study ultimately became a pre-post study with only 1 intervention arm.

Conditions

Grief; Bereavement

Keywords

Portugal; Older adults; Mourning; Task Model; Dual Process of Coping; Loneliness; Depression

Outcome Measures

Primary Outcomes (2)

• Change from baseline (t0) in the Texas Revised Inventory of Grief (TRIG) at 10 weeks (t1)

  Original version of TRIG (English) adapted to European Portuguese. The TRIG is a widely used self-reported measure to assess the severity of grief symptoms. A factor analysis identified three factors for Emotional Response, Thoughts, and Non-Acceptance regarding a loss. The TRIG is a 21-item measure to assess the severity of grief symptoms from 1 = completely true to 5 = completely false.

  Baseline (t0) and 10 weeks (t1)

• Change from baseline (t0) in the Texas Revised Inventory of Grief (TRIG) at 20 weeks (t2)

  Original version of TRIG (English) adapted to European Portuguese. The TRIG is a widely used self-reported measure to assess the severity of grief symptoms. A factor analysis identified three factors for Emotional Response, Thoughts, and Non-Acceptance regarding a loss (Futterman A et al, 2010). The TRIG is a 21-item measure to assess the severity of grief symptoms from 1 = completely true to 5 = completely false.

  Baseline (t0) and 20 weeks (t2)

Secondary Outcomes (4)

• Change from baseline (t0) in the Patient Health Questionnaire-9 (PHQ-9) at 10 weeks (t1)

  Baseline (t0) and 10 weeks (t1)

• Change from baseline (t0) in the Patient Health Questionnaire-9 (PHQ-9) at 20 weeks (t2)

  Baseline (t0) and 20 weeks (t2).

• Change from baseline (t0) in the UCLA Loneliness scale at 10 weeks (t1)

  Baseline (t0) and 10 weeks (t1)

• Change from baseline (t0) in the UCLA Loneliness scale at 20 weeks (t2)

  Baseline (t0) and 20 weeks (t2)

Study Arms (2)

LEAVES + usual care

EXPERIMENTAL

The intervention consists of LEAVES online programme + usual care. LEAVES consists of 10 modules of readings and exercises.

Other: LEAVES

usual care

NO INTERVENTION

The control arm consists of the usual care which entails continuation of existing medication, with or without adjustments, continuation of the person's usual medical, psychological and/or nursing appointments whenever previously scheduled or deemed necessary. GRAI will also be given to participants at baseline (t0) and those meeting the criteria will be referred to specialized grief appointments.

Interventions

LEAVES OTHER

LEAVES consists of 10 modules of readings and exercises. Readings are filled with evidence-based information on grief-related topics (e.g., how to positively influence thoughts, emotions and behaviours), followed by exercises which encourage mourners to actively reflect on what was learned and apply their new knowledge into their grief journey and coping strategies (e.g., how to change attentional focus). Users are encouraged to work through one module per week and complete the assignments.

LEAVES + usual care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 55 years
• Experience of past marital bereavement (participants do not need to have been legally married)
• Willingness to accept help to cope with grief, psychological distress, or the psychosocial adaptation to a life without the partner
• Internet access and access to a computer or smartphone or tablet
• Fluency in Portuguese
• Registered in ULSBA's primary care services

You may not qualify if:

• Severe psychological/ somatic disorders requiring immediate treatment
• Acute suicidality (assessed in the initial risk assessment)
• Marital bereavement less than one month ago
• Inability to follow the study's procedures due to a psychological or physical impairment (e.g., comprehension problems and visual impairment)
• Absent or incomplete informed consent
• Digital illiteracy and no family member/friend/caregiver to help

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Unidade Local de Saúde do Baixo Alentejo: collaborator
• Fundação para a Ciência e a Tecnologia: collaborator
• European Commission: collaborator

Study Sites (1)

Unidade Local de Saúde do Baixo Alentejo (ULSBA)

Beja, 7801-849, Portugal

Location

Related Publications (18)

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  PMID: 31003114 BACKGROUND

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  PMID: 7802116 BACKGROUND

• Molina N, Viola M, Rogers M, Ouyang D, Gang J, Derry H, Prigerson HG. Suicidal Ideation in Bereavement: A Systematic Review. Behav Sci (Basel). 2019 May 14;9(5):53. doi: 10.3390/bs9050053.

  PMID: 31091772 BACKGROUND

• Stahl ST, Schulz R. Changes in routine health behaviors following late-life bereavement: a systematic review. J Behav Med. 2014 Aug;37(4):736-55. doi: 10.1007/s10865-013-9524-7. Epub 2013 Jul 24.

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• Stroebe M, Schut H, Stroebe W. Health outcomes of bereavement. Lancet. 2007 Dec 8;370(9603):1960-73. doi: 10.1016/S0140-6736(07)61816-9.

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• Parisi A, Sharma A, Howard MO, Blank Wilson A. The relationship between substance misuse and complicated grief: A systematic review. J Subst Abuse Treat. 2019 Aug;103:43-57. doi: 10.1016/j.jsat.2019.05.012. Epub 2019 May 23.

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• Lundorff M, Holmgren H, Zachariae R, Farver-Vestergaard I, O'Connor M. Prevalence of prolonged grief disorder in adult bereavement: A systematic review and meta-analysis. J Affect Disord. 2017 Apr 1;212:138-149. doi: 10.1016/j.jad.2017.01.030. Epub 2017 Jan 23.

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• Aoun SM, Breen LJ, Howting DA, Rumbold B, McNamara B, Hegney D. Who needs bereavement support? A population based survey of bereavement risk and support need. PLoS One. 2015 Mar 26;10(3):e0121101. doi: 10.1371/journal.pone.0121101. eCollection 2015.

  PMID: 25811912 BACKGROUND

• Ott CH, Lueger RJ, Kelber ST, Prigerson HG. Spousal bereavement in older adults: common, resilient, and chronic grief with defining characteristics. J Nerv Ment Dis. 2007 Apr;195(4):332-41. doi: 10.1097/01.nmd.0000243890.93992.1e.

  PMID: 17435484 BACKGROUND

• Eisma MC, Boelen PA, van den Bout J, Stroebe W, Schut HA, Lancee J, Stroebe MS. Internet-Based Exposure and Behavioral Activation for Complicated Grief and Rumination: A Randomized Controlled Trial. Behav Ther. 2015 Nov;46(6):729-48. doi: 10.1016/j.beth.2015.05.007. Epub 2015 May 28.

  PMID: 26520217 BACKGROUND

• Litz BT, Schorr Y, Delaney E, Au T, Papa A, Fox AB, Morris S, Nickerson A, Block S, Prigerson HG. A randomized controlled trial of an internet-based therapist-assisted indicated preventive intervention for prolonged grief disorder. Behav Res Ther. 2014 Oct;61:23-34. doi: 10.1016/j.brat.2014.07.005. Epub 2014 Jul 24.

  PMID: 25113524 BACKGROUND

• van der Houwen K, Schut H, van den Bout J, Stroebe M, Stroebe W. The efficacy of a brief internet-based self-help intervention for the bereaved. Behav Res Ther. 2010 May;48(5):359-67. doi: 10.1016/j.brat.2009.12.009. Epub 2009 Dec 23.

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• Wagner B, Knaevelsrud C, Maercker A. Internet-based cognitive-behavioral therapy for complicated grief: a randomized controlled trial. Death Stud. 2006 Jun;30(5):429-53. doi: 10.1080/07481180600614385.

  PMID: 16610157 BACKGROUND

• DELA Innovation Lab. Before You Leave App [Internet]. 2018. URL: https://beforeyouleave.nl/ [Accessed 10.12.2020]

  BACKGROUND

• van Velsen L, Cabrita M, Op den Akker H, Brandl L, Isaac J, Suarez M, Gouveia A, Dinis de Sousa R, Rodrigues AM, Canhao H, Evans N; DELA Natura- En Levensverzekeringen NV; Blok M, Alcobia C, Brodbeck J. LEAVES (optimizing the mentaL health and resiliencE of older Adults that haVe lost thEir spouSe via blended, online therapy): Proposal for an Online Service Development and Evaluation. JMIR Res Protoc. 2020 Sep 8;9(9):e19344. doi: 10.2196/19344.

  PMID: 32897238 BACKGROUND

• Instituto Nacional de Estatística. Censos 2021 - Resultados preliminares [Internet]. 2021. URL: https://www.ine.pt/scripts/db_censos_2021.html [Accessed 01/11/2021]

  BACKGROUND

• Futterman A, Holland JM, Brown PJ, Thompson LW, Gallagher-Thompson D. Factorial validity of the Texas Revised Inventory of Grief-Present scale among bereaved older adults. Psychol Assess. 2010 Sep;22(3):675-87. doi: 10.1037/a0019914.

  PMID: 20822280 BACKGROUND

• Brodbeck J, Jacinto S, Gouveia A, Mendonca N, Madorin S, Brandl L, Schokking L, Rodrigues AM, Goncalves J, Mooser B, Marques MM, Isaac J, Nogueira V, Matos Pires A, van Velsen L. A Web-Based Self-help Intervention for Coping With the Loss of a Partner: Protocol for Randomized Controlled Trials in 3 Countries. JMIR Res Protoc. 2022 Nov 30;11(11):e37827. doi: 10.2196/37827.

  PMID: 36449341 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ana M Rodrigues, MD

  Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

• Ana M Pires, MD

  Unidade Local de Saúde do Baixo Alentejo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: LEAVES-PT will be an open label trial where both participants and researchers are aware to which arm participants have been assigned to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: LEAVES-PT was planned to be a single-centre, pragmatic randomised two-armed parallel-group controlled trial to evaluate the clinical effectiveness on grief of a 10-week open-label intervention of an internet-based self-help spousal bereavement support service (LEAVES) in Portugal vs. usual care. The plan was for participants registered in ULSBA's primary care services to be invited to participate and randomised to one of two arms: LEAVES support service + usual care or usual care. For ethical purposes, participants allocated to the control group will be offered (but not monitored) the LEAVES support service at no cost after the end of the study if requested. However, due to recruitment barriers, the study became a pre-post study with only 1 intervention arm.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 14, 2021
• Study Start: May 27, 2022
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)