Clinical trial NCT05219760: LIVIA 2.0 : A RCT Of Two French Internet Intervention For Adults Struggling With Prolonged Grief Symptoms
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Grief Disorder
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in complicated grief symptoms
timeFrame: Pretest; 12-week post-test; 3-month Follow-up
measure: Change in depression symptoms
timeFrame: Pretest; 12-week post-test; 3-month Follow-up
measure: Change in well-being
timeFrame: Pretest; 12-week post-test; 3-month Follow-up
Secondary outcomes:
measure: Change in anxiety symptoms
timeFrame: Pretest; 12-week post-test; 3-month Follow-up
measure: Change in grief coping strategies
timeFrame: Pretest; 12-week post-test; 3-month Follow-up
measure: Change in aspects related to identity
timeFrame: Pretest; 12-week post-test; 3-month Follow-up
measure: Satisfaction with the program (utility, clarity, impact, etc.) assessed by an adapted version of the CSQ-I
timeFrame: 12-week post-test
measure: Change in the monitoring of the mood, solitude feelings and grief symptoms
timeFrame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
measure: Indicators of verbal immediacy (use of first-person pronouns and present tense words) and so-called "we-talk" (first-person plural pronouns)
timeFrame: 12-week Post-test
measure: Degree of required guidance in each group
timeFrame: 12-week Post-test
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne - Institute of Psychology
state: Vaud
Study officials:
affiliation: University of Lausanne
name: Valentino Pomini
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.