Evaluation of a French Unguided Internet-based Intervention for Adults Struggling With Their Partner's Loss
NCT ID: NCT03714516
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2018-09-12
2021-06-04
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
Yes
Sponsors
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University of Lausanne
OTHER
Responsible Party
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Debrot Anik
Principal Investigator
Principal Investigators
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Valentino Pomini, Prof.
Role: STUDY_DIRECTOR
University of Lausanne
Locations
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University of Lausanne - Institute of Psychology
Lausanne, Canton of Vaud, Switzerland
Countries
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References
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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
Related Links
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Recruitment page
Other Identifiers
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2018-00401
Identifier Type: -
Identifier Source: org_study_id