Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 5:19 AM
Study NCT ID:
NCT05219760
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2021-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIVIA 2.0 : A RCT Of Two French Internet Intervention For Adults Struggling With Prolonged Grief Symptoms
Sponsor:
Debrot Anik
Organization:
Study Overview
Official Title:
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)
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Secondary objectives are the following:
* Participants of LIVIA 2.0 will require less guidance (number of people requesting support and number of e-mails exchanged) than participants in LIVIA 1. The investigators will also explore which session triggers more requests of guidance.
* Using a monitoring of participants' state throughout the completion of the programme in LIVIA 2.0, the investigators will explore the short-term efficacy of each module on participants' weekly mood, solitude feelings and grief symptoms.
* The investigators will compare participants' satisfaction in both versions of LIVIA.
* The investigators will also explore the role of attachment style, type of loss, relationship quality with the partner, the interpersonal closeness with the lost person, symptom severity and level of solitude at onset as moderators of the efficacy of the programmes.
* The investigators will explore the semantic content of the exercises included in the programme to see if this is related with the improvement over the assessment period.
* Participants of LIVIA 2.0 will require less guidance (number of people requesting support and number of e-mails exchanged) than participants in LIVIA 1. The investigators will also explore which session triggers more requests of guidance.
* Using a monitoring of participants' state throughout the completion of the programme in LIVIA 2.0, the investigators will explore the short-term efficacy of each module on participants' weekly mood, solitude feelings and grief symptoms.
* The investigators will compare participants' satisfaction in both versions of LIVIA.
* The investigators will also explore the role of attachment style, type of loss, relationship quality with the partner, the interpersonal closeness with the lost person, symptom severity and level of solitude at onset as moderators of the efficacy of the programmes.
* The investigators will explore the semantic content of the exercises included in the programme to see if this is related with the improvement over the assessment period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: