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

N/ACompletedNCT05219760

Debrot Anik64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Interventions

LIVIADEVICE

The study 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. Both programs are composed of 10 weekly sessions proposing educational material, questionnaires and exercises. They are based on current scientific theories of grief but present their content differently. Compared to LIVIA 1, LIVIA 2.0 is less based on academic readings and participants can choose more freely which topics and exercises they want to do. LIVIA 2.0 also offers a system of reminder messages to maximize adherence as well as more elaborate automated guidance.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in complicated grief symptoms

assessed with a French version (Cherblanc \& Zech, 2021) of The Traumatic Grief Inventory (Boelen et al., 2019), on a scale ranging from 1 = never to 5 = always. The mean score is used as a final score. Higher score represent a higher symptom load.