Complicated GriefLIVIA-FRNCT03714516
Evaluation of a French Unguided Internet-based Intervention for Adults Struggling With Their Partner's Loss
A study testing Psychological internet intervention in people with Complicated Grief, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of this study is to demonstrate the effectiveness of an unguided self-help program for people struggling with the loss of their partner, either by separation/divorce or death. The self-support program lasts 2 months and a half to 3 months. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complicated Grief
- What is being tested?
- Psychological internet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Sep 2018to 4 Jun 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Romantic bereavement or separation/divorce. Either of these events must have happened more than 6 months before participating in the study.
- Subjective distress and need for support to cope with the loss
- Age: 20 years or older
- Internet access
- Mastery of the French language
- Approved Informed Consent (Appendix Informed Consent Form)
Who cannot join
- Moderate to acute current suicidality (BDI-II item 9 > 1)
- Severe psychological or somatic disorders which need immediate treatment.
- Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
- Prescribed drugs against depression or anxiety, if prescription or dosage has changed 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
About this study
Official title: LIVIA-FR: Non-controlled Evaluation of a French Unguided Internet-based Self-help Intervention for Adults Struggling With Prolonged Grief Symptoms After the Loss of Their Romantic Partner (Bereavement or Separation/Divorce)
The purpose of this study is to demonstrate the effectiveness of an unguided self-help program for people struggling with the loss of their partner, either by separation/divorce or death. The self-support program lasts 2 months and a half to 3 months. It was developed in German by a team from the University of Bern and has already proven its effectiveness. All participants will have direct access to the program (there will be no control group). The results obtained will be compared to those collected by the authors of the original program who administered the same intervention to a German-speaking population, however with support by e-mail.
Participation is open to anyone aged 20 or over who has lost their partner through bereavement, divorce or separation at least 6 months ago, and who has difficulty overcoming this loss. However, it is not possible to participate if the person is on psychotherapeutic therapy, has started or changed psychotropic medication or if the person has any risk of suicide. Alternative possibilities of treatment will be proposed.
Read more
The self-support consists of 10 modules, which contain information about the process of loss, self-reflection tasks, activities, questionnaires and self-observation grids. Participants are free to do the modules as many times as they wish. They will also be asked three times to complete questionnaires taking an average of 40 minutes. This will take place before the start of the program, at the end of the program, and 3 months after the end of the intervention.
At the end of the program, participants will be asked for feedback on the program. These data and remarks will allow to rethink and improve the care of people with difficulties overcoming the loss of a loved one.
Participants will be recruited by contacting various associations dealing with bereavement and / or separation, as well as by posting advertisements or articles in the media (social or conventional) in the French-speaking part of Switzerland.
Read the detailed description
Internet-based self-help interventions have proved to have beneficial effects on a broad range of disorders including complicated grief disorder. Additionally, initial evidence is provided for the effectiveness of a cognitive-behaviorally-oriented online guided intervention for the milder grief symptoms. Unguided online interventions have a favorable cost-benefit ratio . French empirically supported online interventions are scarce, and to our knowledge, no such intervention exists for grieving individuals.
The primary purpose of this study is to evaluate the efficacy of this unguided internet-based self-help intervention on distress and well-being.
The secondary purpose is to assess the effects of the intervention on coping abilities, social integration and physical health after romantic bereavement or separation/divorce in adults. Additionally, the aim is to collect information about the users' perception of the program and their satisfaction with it. This information will be taken into account in order to develop an enhanced version of the program.
The primary outcomes are: distress symptoms (grief, depression, and anxiety) and well-being (satisfaction with life and eudaimonic well-being).
The main secondary outcomes are: coping abilities (grief-related avoidance, coping style), social integration (loneliness and social support), and finally the physical health state (physical symptoms and sleep quality).
Additionally, information about the satisfaction with the program will be collected and taken into account to develop a second, enhanced version of the program.
The design is a non-controlled evaluation pilot study with pre-, post- and follow-up assessments.
Participants fulfilling all the following inclusion criteria are eligible for the study:
- Romantic bereavement or separation/divorce. Either of these events must have happened more than 6 months before participating in the study.
- Subjective distress and need for support to cope with the loss
- Age: 20 years or older
- Regular internet access
- Mastery of the French language
- Approved Informed Consent (Appendix Informed Consent Form)
The presence of any of the following exclusion criteria will lead to exclusion of the participant :
- Moderate to acute current suicidality
- Severe psychological or somatic disorders which need immediate treatment.
- Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
- Prescribed drugs against depression or anxiety, if prescription or dosage has changed in the month prior or during the self-help intervention.
- Inability to follow the procedures of the study, e.g. due to comprehension problems
- Enrollment of the investigator, their family members, employees and other dependent persons.
Measurements: online-questionnaires will be used to assess the effects of the intervention at three measurement points: at baseline, at 12-weeks directly after the intervention and at follow-up 3-months after the end of the intervention.
Procedure: Participants will be recruited by contacting several grief-related associations in the French-speaking area of Switzerland, and by posting ads in the (social) media (see Appendices 9 and 10). First, interested persons will fill in a short questionnaire checking the participation criteria. Then, if eligible, they will approve the online informed consent and complete the baseline measures. Next, participants receive their login details for the internet-based self-help intervention. The 10 sessions will be self-administrated. The recommendation is to spend one week per session. Participants are free to go through the sessions as often as they wish.
The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques.
There will be no control intervention. However, the results (effect sizes) will be compared to the ones of the original authors of the program , who administered the same intervention to a German-speaking population (note however that the original program is an internet-based guided intervention, where weekly e-mail support was offered to the participants). The study will include at least 23 participants.
- Conditions
- Complicated Grief
- Being tested
- Psychological internet intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological internet interventionBehavioural
The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Online psychological intervention | Experimental | The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques. Receives: Behavioral: Psychological internet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in complicated grief symptoms (score at the Inventory of Complicated Grief)
assessed with: Inventory of Complicated Grief (Prigerson et al., 1995; Zech, 2012), on a scale ranging from 0 = never to 4 = always. The mean score is used as a final score. Higher score represent a higher symptom load.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Secondary outcomes (10)
Change in Anxiety and Depression symptoms (score at the Hospital Anxiety and Depression Scale)
assessed with the Hospital Anxiety and Depression Scale (Savard, Laberge, Gauthier, Ivers, \& Bergeron, 1998; Zigmond \& Snaith, 1983). The mean score is used as a final score. Higher score represent a higher symptom load.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in Psychological Well-Being (score at the Psychological Well-Being Scales)
Psychological Well-Being Scales (Bouffard \& Lapierre, 1997; Ryff, 1989; van Dierendonck, 2004) assessed on a scale ranging from 1 = I completely disagree, to 6 = I completely agree. The mean score is used as a final score. Higher score represent a better psychological well-being.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in Satisfaction with Life (score at the Satisfaction with Life Scale)
Satisfaction with Life Scale (Blais, Vallerand, Pelletier, \& Brière, 1989; Diener, Emmons, Larsen, \& Griffin, 1985) assessed on a scale ranging from 1 = I disagree strongly, to 7 = I agree strongly. The mean score is used as a final score. Higher score represent a better satisfaction with one's own life.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in Grief-Related Avoidance (score at the Grief-Related Avoidance Questionnaire)
Grief-Related Avoidance Questionnaire (Shear et al., 2007), assessed on a scale ranging from 0 = never to 4 = always. The mean score is used as a final score. Higher scores represent a higher tendency to avoid situations that could remind of the loss and is associated with worse outcomes.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in Coping strategies (score at the Brief-COPE)
Brief-COPE (Carver, Scheier, \& Weintraub, 1989; Muller \& Spitz, 2003) assesses 14 different typical coping strategies (Active coping, Planning, Suppression of competing activities, Restraint coping, Seeking social support - instrumental, Seeking social support - emotional, Positive reinterpretation \& growth, Acceptance, Turning to religion, Focus on \& venting of emotions, Denial, Behavioral disengagement, Mental disengagement, Alcohol-drug disengagement) on a scale ranging from 1 = not at all, to 4 = always. The average of each dimension is used separately. Higher scores represent a higher use of the coping strategy.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in loneliness (score at the De Jong Gierveld Short Scale for Emotional and Social Loneliness, short version)
Short Version of the De Jong Gierveld Short Scale for Emotional and Social Loneliness (de Jong Gierveld \& van Tilburg, 2010; Vandenbroucke et al, 2012), on a scale ranging from 1 = yes, to 3 = no. The mean score is used as a final score. Higher score represent a higher self-perceived loneliness.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in perceived social support (score at the Social Support Questionnaire)
Social Support Questionnaire (Bruchon-Schweitzer, Rascle, Gelie, Fortier, Sifakis, \& Constant, 2003; Sarason, Sarason, Shearin, \& Pierce, 1987) on a scale ranging from 1 = very unsatisfied, to 6 = very satisfied. The mean score is used as a final score. Higher scores represent a higher satisfaction with the available social support.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in sleep problems (score at the Pittsburgh Sleep Quality Index)
The Pittsburgh Sleep Quality Index (PSQI; Blais, Gendron, Mimeault, \& Morin, 1997; Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989) includes 19 self-rated questions about a variety of factors relating to sleep quality. They are then grouped into 7 components scores, each weighted equally on a 0-3 scale. These scores are then summed in a global PSQI score (range 0-21). A higher score represents more sleep problems.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Change in physical symptoms (score at the Physical Health Questionnaire)
The Physical Health Questionnaire (Kroenke, Spitzer, \& Williams, 2002; Maggiori, 2010) assesses 15 physical symptoms on a scale ranging from 1 = not at all bothered, to 3 = very much bothered. The mean score is used as a final score. Higher scores represent a higher symptom load.
Measured: Pretest / 12-week posttest / 3-month Follow-up
Satisfaction with the program (utility, clarity, impact, etc.)
Self-designed questionnaire assessing different quantitative and qualitative questions on the satisfaction with the program. These questions will be evaluated separately.
Measured: 12-week Posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start12 Sep 2018
- Primary completion31 Dec 2020
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated GriefStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- non-controlled evaluation pilot study with pre-, post- and follow-up assessments
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debrot Anik, University of Lausanne
- Investigators
- Valentino Pomini, Prof., Study director, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714516
- Sponsor's protocol ID
- 2018-00401
- Other IDs
- 2018
- Acronym
- LIVIA-FR
- Status last verified
- Nov 2021
- First submitted
- 21 Sep 2018
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publishing the results, we will make the codified data available on request.
Publications
Efinger, L., Debrot, A., & Pomini, V. (2021). LIVIA-FR : Implémentation et évaluation d'une intervention par Internet pour des personnes francophones peinant à surmonter la perte de leur partenaire. Annales Médico-Psychologiques, Revue Psychiatrique. Advance online publication. https://doi.org/10.1016/j.amp.2021.05.004
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIVIA-FR: Non-controlled Evaluation of a French Unguided Internet-based Self-help Intervention for Adults Struggling With Prolonged Grief Symptoms After the Loss of Their Romantic Partner (Bereavement or Separation/Divorce)
- ClinicalTrials.gov ID
- NCT03714516
- Acronym / sponsor ID
- LIVIA-FR / 2018-00401
- Conditions
- Complicated Grief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 22 Oct 2018 (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.
The purpose of this study is to demonstrate the effectiveness of an unguided self-help program for people struggling with the loss of their partner, either by separation/divorce or death. The self-support program lasts 2 months and a half to 3 months. It was developed in German by a team from the University of Bern and has already proven its effectiveness. All participants will have direct access to the program (there will be no control group). The results obtained will be compared to those collected by the authors of the original program who administered the same intervention to a German-speaking population, however with support by e-mail.
Participation is open to anyone aged 20 or over who has lost their partner through bereavement, divorce or separation at least 6 months ago, and who has difficulty overcoming this loss. However, it is not possible to participate if the person is on psychotherapeutic therapy, has started or changed psychotropic medication or if the person has any risk of suicide. Alternative possibilities of treatment will be proposed.
The self-support consists of 10 modules, which contain information about the process of loss, self-reflection tasks, activities, questionnaires and self-observation grids. Participants are free to do the modules as many times as they wish. They will also be asked three times to complete questionnaires taking an average of 40 minutes. This will take place before the start of the program, at the end of the program, and 3 months after the end of the intervention.
At the end of the program, participants will be asked for feedback on the program. These data and remarks will allow to rethink and improve the care of people with difficulties overcoming the loss of a loved one.
Participants will be recruited by contacting various associations dealing with bereavement and / or separation, as well as by posting advertisements or articles in the media (social or conventional) in the French-speaking part of Switzerland.
Detailed description
Internet-based self-help interventions have proved to have beneficial effects on a broad range of disorders including complicated grief disorder. Additionally, initial evidence is provided for the effectiveness of a cognitive-behaviorally-oriented online guided intervention for the milder grief symptoms. Unguided online interventions have a favorable cost-benefit ratio . French empirically supported online interventions are scarce, and to our knowledge, no such intervention exists for grieving individuals.
The primary purpose of this study is to evaluate the efficacy of this unguided internet-based self-help intervention on distress and well-being.
The secondary purpose is to assess the effects of the intervention on coping abilities, social integration and physical health after romantic bereavement or separation/divorce in adults. Additionally, the aim is to collect information about the users' perception of the program and their satisfaction with it. This information will be taken into account in order to develop an enhanced version of the program.
The primary outcomes are: distress symptoms (grief, depression, and anxiety) and well-being (satisfaction with life and eudaimonic well-being).
The main secondary outcomes are: coping abilities (grief-related avoidance, coping style), social integration (loneliness and social support), and finally the physical health state (physical symptoms and sleep quality).
Additionally, information about the satisfaction with the program will be collected and taken into account to develop a second, enhanced version of the program.
The design is a non-controlled evaluation pilot study with pre-, post- and follow-up assessments.
Participants fulfilling all the following inclusion criteria are eligible for the study:
- Romantic bereavement or separation/divorce. Either of these events must have happened more than 6 months before participating in the study.
- Subjective distress and need for support to cope with the loss
- Age: 20 years or older
- Regular internet access
- Mastery of the French language
- Approved Informed Consent (Appendix Informed Consent Form)
The presence of any of the following exclusion criteria will lead to exclusion of the participant :
- Moderate to acute current suicidality
- Severe psychological or somatic disorders which need immediate treatment.
- Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
- Prescribed drugs against depression or anxiety, if prescription or dosage has changed in the month prior or during the self-help intervention.
- Inability to follow the procedures of the study, e.g. due to comprehension problems
- Enrollment of the investigator, their family members, employees and other dependent persons.
Measurements: online-questionnaires will be used to assess the effects of the intervention at three measurement points: at baseline, at 12-weeks directly after the intervention and at follow-up 3-months after the end of the intervention.
Procedure: Participants will be recruited by contacting several grief-related associations in the French-speaking area of Switzerland, and by posting ads in the (social) media (see Appendices 9 and 10). First, interested persons will fill in a short questionnaire checking the participation criteria. Then, if eligible, they will approve the online informed consent and complete the baseline measures. Next, participants receive their login details for the internet-based self-help intervention. The 10 sessions will be self-administrated. The recommendation is to spend one week per session. Participants are free to go through the sessions as often as they wish.
The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques.
There will be no control intervention. However, the results (effect sizes) will be compared to the ones of the original authors of the program , who administered the same intervention to a German-speaking population (note however that the original program is an internet-based guided intervention, where weekly e-mail support was offered to the participants). The study will include at least 23 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-controlled evaluation pilot study with pre-, post- and follow-up assessments
| Arm | Type | Receives |
|---|---|---|
| Online psychological intervention | Experimental | Behavioral: Psychological internet interventionThe intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Romantic bereavement or separation/divorce. Either of these events must have happened more than 6 months before participating in the study.
- Subjective distress and need for support to cope with the loss
- Age: 20 years or older
- Internet access
- Mastery of the French language
Key exclusion criteria (6 listed)
- Moderate to acute current suicidality (BDI-II item 9 > 1)
- Severe psychological or somatic disorders which need immediate treatment.
- Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
- Prescribed drugs against depression or anxiety, if prescription or dosage has changed 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 |
|---|---|---|
| Psychological internet interventionThe intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques. | Behavioural | Online psychological intervention |
Primary outcome
Change in complicated grief symptoms (score at the Inventory of Complicated Grief)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
assessed with: Inventory of Complicated Grief (Prigerson et al., 1995; Zech, 2012), on a scale ranging from 0 = never to 4 = always. The mean score is used as a final score. Higher score represent a higher symptom load.
10 secondary outcomes
Change in Anxiety and Depression symptoms (score at the Hospital Anxiety and Depression Scale)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in Psychological Well-Being (score at the Psychological Well-Being Scales)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in Satisfaction with Life (score at the Satisfaction with Life Scale)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in Grief-Related Avoidance (score at the Grief-Related Avoidance Questionnaire)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in Coping strategies (score at the Brief-COPE)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in loneliness (score at the De Jong Gierveld Short Scale for Emotional and Social Loneliness, short version)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in perceived social support (score at the Social Support Questionnaire)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in sleep problems (score at the Pittsburgh Sleep Quality Index)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Change in physical symptoms (score at the Physical Health Questionnaire)
Time frame: Pretest / 12-week posttest / 3-month Follow-up
Satisfaction with the program (utility, clarity, impact, etc.)
Time frame: 12-week Posttest
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 24 Nov 2021.
- BackgroundEfinger, L., Debrot, A., & Pomini, V. (2021). LIVIA-FR : Implémentation et évaluation d'une intervention par Internet pour des personnes francophones peinant à surmonter la perte de leur partenaire. Annales Médico-Psychologiques, Revue Psychiatrique. Advance online publication. https://doi.org/10.1016/j.amp.2021.05.004
- Recruitment pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After publishing the results, we will make the codified data available on request.
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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, Prof. study director
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 Psychological internet intervention in people with Complicated Grief, run by University of Lausanne 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 24 Nov 2021. 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 (score at the Inventory of Complicated Grief) (time frame: Pretest / 12-week posttest / 3-month Follow-up). 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 NCT03714516, which also lists 1 linked publication.
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 24 Nov 2021.