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

Study Overview
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Brief Summary
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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
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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.

Official Title
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LIVIA 2.0: A Randomized Controlled Trial of Two French Internet Intervention for Adults Struggling With Prolonged Grief Symptoms After the Loss of a Close One (by Bereavement or Separation/Divorce)

Conditions
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Prolonged Grief Disorder

Intervention / Treatment
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* Device: LIVIA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LIVIA 1<br>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<br>* 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.<br>|
| Experimental: LIVIA 2.0<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms | assessed with the Generalized Anxiety Scale (Micoulaud-Franchi et al., 2016; Spitzer et al., 2006), 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 grief coping strategies | measured with the Coping with Bereavement Questionnaire (Ryckebosch-Dayez et al., 2016), on a scale ranging from 1 = almost never to 5 = always. Higher scores represent a higher use of the coping strategy. | Pretest; 12-week post-test; 3-month Follow-up | 
| Change in aspects related to identity | Measured with three scales: The Self-Concept Clarity (Brunot et al., 2015; Campbell et al., 1996) has a scale ranging from 1 = I completely disagree to 5 = I completely agree. The mean score is used as a final score. Higher score represent a lesser clarity of the self-concept. The Centrality of Event Scale (Berntsen & Rubin, 2006; Ceschi et al., 2009) has a scale ranging from 1 = I completely disagree to 5 = I completely agree. The mean score is used as a final score. Higher score represent a higher centrality of the event of loss. Questions about self-continuity (Lampraki et al., 2019), on a scale ranging from 1 = does not suit me to 5 = suits me perfectly. The mean score is used as a final score. Higher score represent a higher self-continuity. | 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 | The investigators will measure the satisfaction with the program, by using a translated and adapted version of the Client Satisfaction Questionnaire (CSQ-I; Boß et al., 2016) assessing different quantitative and qualitative questions. These questions will be evaluated separately. | 12-week post-test | 
| Change in the monitoring of the mood, solitude feelings and grief symptoms | The investigators will weekly monitor the mood of the participants of LIVIA 2 using a single item (How would you describe your current mood on a scale ranging from 0 (very bad) to 6 (very good). Moreover, the investigators will weekly monitor the grief and solitude symptoms on a scale ranging from 1 (strongly disagree) to 5 (strongly agree) with the following items: During the past 24 hours: (1) I have felt negative emotions ; (2) I have had negative images or thoughts ; (3) I felt blocked in my behaviour (what I do, my activities) ; (4) I felt lonely ; (5) I felt like I had a clear sense of who I am and what I want in life. | Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 | 
| Indicators of verbal immediacy (use of first-person pronouns and present tense words) and so-called we-talk (first-person plural pronouns) | The investigators will analyse the linguistic behaviours and the semantic content in the exercises where the participants are required to describe a situation related to the loss. The objective is to test if some semantic categories (e.g. we-talk, Bourassa et al., 2018) are associated with the efficacy of the programme. | 12-week Post-test | 
| Degree of required guidance in each group | number of participants requiring guidance and number of e-mails exchanged | 12-week Post-test |