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

NCT05219760 | Completed DMC

• 1 other identifier: 2021-D0086
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolonged Grief Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  Pretest; 12-week post-test; 3-month Follow-up

• Change in depression symptoms

  assessed with the Patient Health Questionnaire-9 (Kroenke \& Spitzer, 2002; Kroenke, Spitzer \& Williams, 2001), on a scale ranging from 0 = never to 4 = practically every day. The sum of the scores is used as a final score. Higher score represent a higher symptom load.

  Pretest; 12-week post-test; 3-month Follow-up

• Change in well-being

  measured with the French version (Villieux et al., 2016) of the Flourishing Scale (Diener et al., 2010), on a scale ranging from 1 = I completely disagree, to 7 = I completely agree. The mean score is used as a final score. Higher score represent a better psychological well-being.

  Pretest; 12-week post-test; 3-month Follow-up

Secondary Outcomes (7)

• Change in anxiety symptoms

  Pretest; 12-week post-test; 3-month Follow-up

• Change in grief coping strategies

  Pretest; 12-week post-test; 3-month Follow-up

• Change in aspects related to identity

  Pretest; 12-week post-test; 3-month Follow-up

• Satisfaction with the program (utility, clarity, impact, etc.) assessed by an adapted version of the CSQ-I

  12-week post-test

• Change in the monitoring of the mood, solitude feelings and grief symptoms

  Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85

Study Arms (2)

LIVIA 1

ACTIVE COMPARATOR

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.

Device: LIVIA

LIVIA 2.0

EXPERIMENTAL

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.

Device: LIVIA

Interventions

LIVIA DEVICE

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.

LIVIA 1; LIVIA 2.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Debrot Anik: lead

Study Sites (1)

University of Lausanne - Institute of Psychology

Lausanne, Canton of Vaud, 1015, Switzerland

Location

Related Publications (2)

• Debrot A, Efinger L, Kheyar M, Pomini V, Berthoud L. A French-Language Web-Based Intervention Targeting Prolonged Grief Symptoms in People Who Are Bereaved and Separated: Randomized Controlled Trial. JMIR Form Res. 2024 Oct 16;8:e57294. doi: 10.2196/57294.

  PMID: 39412869 DERIVED

• Debrot A, Kheyar M, Efinger L, Berthoud L, Pomini V. Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions. JMIR Res Protoc. 2022 Jun 23;11(6):e39026. doi: 10.2196/39026.

  PMID: 35737454 DERIVED

Related Links

• Website of the program

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Valentino Pomini

  University of Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 2, 2022
• Study Start: May 6, 2022
• Primary Completion: January 31, 2023
• Study Completion: August 10, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Access Criteria: The investigators demand that the purpose of the request is clearly stated.

Locations

CH (1)