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

Debrot Anik

Status: Completed

Conditions: Prolonged Grief Disorder

Treatments: Device: LIVIA

Study type: Interventional

Funder types: Other

Identifiers

NCT05219760

2021-D0086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

LIVIA 1

Active Comparator group

Description:

LIVIA 1 is a 12-week intervention composed of 10 sessions, whereby we recommend completing one session per week. It includes psychoeducational content and exercises that are based on empirically validated intervention tools, mainly issued from Cognitive-Behavioral Therapy.

Treatment:

Device: LIVIA

LIVIA 2.0

Experimental group

Description:

LIVIA 2.0 is a 12-week intervention composed of 10 sessions, whereby we recommend completing one session per week. It includes psychoeducational content and exercises that are based on empirically validated intervention tools, mainly issued from Cognitive-Behavioral Therapy but also from positive psychology and cognitive psychopathology frame.

Treatment:

Device: LIVIA