CompletedNot Applicable

LIVIA 2.0 : A RCT Of Two French Internet Intervention For Adults Struggling With Prolonged Grief Symptoms

Switzerland64 participantsStarted 2022-05-06

Plain-language summary

The investigators aim to compare the efficacy of an IBI targeting complicated grief symptoms (LIVIA 2.0) compared to an already investigated IBI (LIVIA 1) using a guidance on demand design in a randomised controlled trial (RCT). More specifically, the investigators will test the following primary hypotheses: * Both interventions will significantly increase participants' well-being and decrease their distress, and those changes will be stable until follow-up. * LIVIA 2.0 will be more efficient than LIVIA 1 on all measure outcomes. * LIVIA 2.0 will have less dropouts than LIVIA 1.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Bereavement or separation/divorce * Either of these events should have happened more than 6 months before participating in the study * Feeling the need for support to cope with the loss (a diagnosis of complicated grief is not necessary) * Age: 18 years or older * Regular Internet access * Mastery of the French language - Approved ICF Exclusion Criteria: * Moderate to acute current suicidality (SIDAS \> 19) * Severe psychological or somatic disorders which need immediate treatment. * Concomitant psychotherapy * Prescription or change in dosage of psychoactive drugs in the month prior or during the self-help intervention. * Inability to follow the procedures of the study, e.g. due to comprehension problems * Enrolment of the investigator, his/her family members, employees, and other dependent persons.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in complicated grief symptoms

Timeframe: Pretest; 12-week post-test; 3-month Follow-up

Change in depression symptoms

Timeframe: Pretest; 12-week post-test; 3-month Follow-up

Change in well-being

Timeframe: Pretest; 12-week post-test; 3-month Follow-up

Trial details

NCT IDNCT05219760

SponsorDebrot Anik

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-31

View on ClinicalTrials.gov More Prolonged Grief Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.