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VR+TAU for Grief (DIANE Trial)
N/A
Waitlist Available
Research Sponsored by Universite du Quebec en Outaouais
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mothers who had recently experienced a perinatal death, including: having lost a child during pregnancy because of miscarriage (i.e., embryo or fetus death prior the 28th week of gestation); termination due to medical indications; stillbirth (i.e., fetus death after 28 completed weeks of gestation); or neonatal death (i.e., infant death within the first 7 days of life).
Women who have experienced perinatal death while pregnant within no more than 1 year before the enrollment will be invited to participate to the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Awards & highlights
DIANE Trial Summary
This trial is looking at whether a VR intervention can help mothers who experienced a perinatal loss. The investigators hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group.
Eligible Conditions
- Grief
- Perinatal
DIANE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDIANE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beck Depression Inventory-II (change)
Clinical Global Impression rated by the therapist (change)
Edinburgh Postnatal Depression Scale (change)
+4 moreSecondary outcome measures
Client Satisfaction Questionnaire
DIANE Trial Design
2Treatment groups
Active Control
Group I: VR+TAUActive Control2 Interventions
Participants will participate first to a VR-based intervention and then to the TAU condition. The TAU condition is a homogenous standard program proposed by the Centre d'études et de recherché en intervention familiale (CERIF) at Université du Québec en Outaouais (UQO) based on group counseling offered to women and men who experienced a perinatal loss.
Group II: TAU+VRActive Control2 Interventions
Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.
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Who is running the clinical trial?
Universite du Quebec en OutaouaisLead Sponsor
12 Previous Clinical Trials
870 Total Patients Enrolled
Fonds de la Recherche en Santé du QuébecOTHER_GOV
80 Previous Clinical Trials
46,508 Total Patients Enrolled
Canadian Research Chair in Family Psychosocial HealthUNKNOWN
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