Prolonged Grief DisorderNCT05219760

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

A study testing LIVIA in people with Prolonged Grief Disorder, run by Debrot Anik at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Prolonged Grief Disorder
What is being tested?: LIVIA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteSwitzerland
Study dates: 6 May 2022to 10 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Switzerland1 site

University of Lausanne - Institute of Psychology
Lausanne, Canton of Vaud, 1015

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Conditions: Prolonged Grief Disorder
Being tested: LIVIA
Medical subject headings: Prolonged Grief Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIVIADevice
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 groups in NCT05219760
Study group	Role	What they receive
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. Receives: 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. Receives: Device: LIVIA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Pretest; 12-week post-test; 3-month Follow-up

Secondary outcomes (7)

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.
Measured: 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.
Measured: Pretest; 12-week post-test; 3-month Follow-up
Change in aspects related to identity
Measured with three scales:
1. 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.
2. 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.
3. 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-week Post-test
Degree of required guidance in each group
number of participants requiring guidance and number of e-mails exchanged
Measured: 12-week Post-test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 202210 Aug 2023

First posted2 Feb 2022
Study start6 May 2022
Primary completion31 Jan 2023
Study completion10 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05219760
Sponsor's protocol ID: 2021-D0086
Status last verified: Sep 2023
First submitted: 23 Dec 2021
Last updated: 8 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After publishing the results, the investigators will make the codified data available on request.

Publications

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.
PubMed 39412869
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.
PubMed 35737454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prolonged Grief Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05219760
Acronym / sponsor ID: 2021-D0086
Conditions: Prolonged Grief Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Debrot AnikUniversity, hospital or other
Study start: 6 May 2022 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: 10 Aug 2023 (actual)
First posted: 2 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
LIVIA 1	Active comparator	Device: LIVIALIVIA 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.
LIVIA 2.0	Experimental	Device: LIVIALIVIA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LIVIAThe 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.	Device	LIVIA 1, LIVIA 2.0

Primary outcome

Change in complicated grief symptoms
Time frame: Pretest; 12-week post-test; 3-month Follow-up
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.
Change in depression symptoms
Time frame: Pretest; 12-week post-test; 3-month Follow-up
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.
Change in well-being
Time frame: Pretest; 12-week post-test; 3-month Follow-up
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.

7 secondary outcomes

Change in anxiety symptoms
Time frame: Pretest; 12-week post-test; 3-month Follow-up
Change in grief coping strategies
Time frame: Pretest; 12-week post-test; 3-month Follow-up
Change in aspects related to identity
Time frame: 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
Time frame: 12-week post-test
Change in the monitoring of the mood, solitude feelings and grief symptoms
Time frame: 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)
Time frame: 12-week Post-test
Degree of required guidance in each group
Time frame: 12-week Post-test

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
Derived from this study: PubMed 39412869Debrot 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.
Derived from this study: PubMed 35737454Debrot 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.
Website of the programLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After publishing the results, the investigators will make the codified data available on request.

Related trials for Prolonged Grief Disorder

Recruiting
Technology-supported Interventions for Prolonged Grief Disorder (PGD)
Prolonged Grief Disorder (PGD)
Active, not recruiting
Iyengar Yoga for Prolonged Grief Disorder
Prolonged Grief Disorder
Not yet recruiting
Mechanisms Underlying Late-Life Prolonged Grief Disorder
Prolonged Grief Disorder
Recruiting
Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder
Prolonged Grief Disorder (PGD)
Recruiting
A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Valentino Pomini principal investigator

University of Lausanne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LIVIA in people with Prolonged Grief Disorder, run by Debrot Anik at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in complicated grief symptoms (time frame: Pretest; 12-week post-test; 3-month Follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219760, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.