Trial reportJMIR formative research2024
A French-Language Web-Based Intervention Targeting Prolonged Grief Symptoms in People Who Are Bereaved and Separated: Randomized Controlled Trial.
Trial report in JMIR formative research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05219760 (LIVIA 2.0), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
LIVIA 2.0: A Randomized Controlled Trial of Two French Internet Intervention for Adults Struggling With Prolonged Grief Symptoms After the Loss of a Close One (by Bereavement or Separation/Divorce)
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLosing a loved one, through death or separation, counts among the most stressful life events and is detrimental to health and well-being. About 15% of people show clinically significant difficulties coping with such an event. Web-based interventions (WBIs) are effective for a variety of mental health disorders, including prolonged grief. However, no validated WBI is available in French for treating prolonged grief symptoms.
objectiveThis study aimed to compare the efficacy and adherence rates of 2 WBIs for prolonged grief symptoms following the loss of a loved one through death or romantic separation.
methodsLIVIA 2.0 was developed relying on theoretical and empirical findings on bereavement processes and WBIs, and is compared with LIVIA 1, which has already demonstrated its efficacy. We conducted a randomized controlled trial and provided on-demand guidance to participants. Outcomes were assessed through web-based questionnaires before the intervention, after the intervention (12 weeks later), and at follow-up (24 weeks later). Primary outcomes were grief symptoms, depressive symptoms, and well-being. Secondary outcomes were anxiety symptoms, grief coping strategies, aspects related to self-identity, and program satisfaction.
resultsIn total, 62 participants were randomized (intent-to-treat [ITT] sample), 29 (47%) in LIVIA 2.0 (active arm) and 33 (53%) in LIVIA 1 (control arm). The dropout rate was 40% (37/62), and 10 participants were removed due to exclusion criteria, leading to a final per-protocol sample of 27 (44%) completers who differed from noncompleters only based on reporting fewer anxiety symptoms (t
conclusionsThe 2 grief-related WBIs were effective in reducing grief, depressive and anxiety symptoms for participants who are bereaved or separated. The analyses did not reveal any pre-post between-group differences, suggesting that the innovations brought to LIVIA 2.0 did not significantly affect the outcome. However, caution is warranted with the interpretation of the results given the limited power of the sample, which only allows the detection of medium effect sizes.
trial registrationClinicalTrials.gov NCT05219760; https://clinicaltrials.gov/study/NCT05219760. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/39026.
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