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

  • STATUS
    Recruiting
  • End date
    Jun 26, 2023
  • participants needed
    234
  • sponsor
    Debrot Anik
Updated on 26 May 2022
Accepts healthy volunteers

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.

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.

Details
Condition Prolonged Grief Disorder
Treatment LIVIA
Clinical Study IdentifierNCT05219760
SponsorDebrot Anik
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
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