Evaluation of a French Unguided Internet-based Intervention for Adults Struggling With Their Partner's Loss (LIVIA-FR)
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| ClinicalTrials.gov Identifier: NCT03714516 |
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Recruitment Status :
Completed
First Posted : October 22, 2018
Last Update Posted : November 24, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Complicated Grief | Behavioral: Psychological internet intervention | Not Applicable |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 47 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | non-controlled evaluation pilot study with pre-, post- and follow-up assessments |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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) |
| Actual Study Start Date : | September 12, 2018 |
| Actual Primary Completion Date : | December 31, 2020 |
| Actual Study Completion Date : | June 4, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Online psychological intervention
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.
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Behavioral: Psychological internet intervention
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. |
- 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.
- Change in Anxiety and Depression symptoms (score at the Hospital Anxiety and Depression Scale) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Change in Psychological Well-Being (score at the Psychological Well-Being Scales) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Change in Satisfaction with Life (score at the Satisfaction with Life Scale) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Change in Grief-Related Avoidance (score at the Grief-Related Avoidance Questionnaire) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Change in Coping strategies (score at the Brief-COPE) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- 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 ]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.
- Change in perceived social support (score at the Social Support Questionnaire) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Change in sleep problems (score at the Pittsburgh Sleep Quality Index) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Change in physical symptoms (score at the Physical Health Questionnaire) [ Time Frame: Pretest / 12-week posttest / 3-month Follow-up ]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.
- Satisfaction with the program (utility, clarity, impact, etc.) [ Time Frame: 12-week Posttest ]Self-designed questionnaire assessing different quantitative and qualitative questions on the satisfaction with the program. These questions will be evaluated separately.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714516
| Switzerland | |
| University of Lausanne - Institute of Psychology | |
| Lausanne, VD, Switzerland, 1015 | |
| Study Director: | Valentino Pomini, Prof. | University of Lausanne |
Publications:
| Responsible Party: | Debrot Anik, Principal Investigator, University of Lausanne |
| ClinicalTrials.gov Identifier: | NCT03714516 |
| Other Study ID Numbers: |
2018-00401 |
| First Posted: | October 22, 2018 Key Record Dates |
| Last Update Posted: | November 24, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | After publishing the results, we will make the codified data available on request. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code |
| Access Criteria: | We demand that the purpose of the request is clearly stated. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |