Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05219760
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.
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.
Study:
NCT05219760
Study Brief:
Protocol Section:
NCT05219760