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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:
Secondary objectives are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valentino Pomini | University of Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lausanne - Institute of Psychology | Lausanne | Canton of Vaud | 1015 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39412869 | Derived | 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. | |
| 35737454 | 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. |
| Label | URL |
|---|---|
| Website of the program | View source |
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After publishing the results, the investigators will make the codified data available on request.
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The investigators demand that the purpose of the request is clearly stated.
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| ID | Term |
|---|---|
| D000090382 | Prolonged Grief Disorder |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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.
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|
| 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:
| 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 |