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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in complicated grief symptoms (score at the Inventory of Complicated Grief)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Change in complicated grief symptoms (score at the Inventory of Complicated Grief)
时间窗: 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.
次要结局
- Change in Anxiety and Depression symptoms (score at the Hospital Anxiety and Depression Scale)(Pretest / 12-week posttest / 3-month Follow-up)
- Change in perceived social support (score at the Social Support Questionnaire)(Pretest / 12-week posttest / 3-month Follow-up)
- Change in physical symptoms (score at the Physical Health Questionnaire)(Pretest / 12-week posttest / 3-month Follow-up)
- Satisfaction with the program (utility, clarity, impact, etc.)(12-week Posttest)
- Change in Coping strategies (score at the Brief-COPE)(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)(Pretest / 12-week posttest / 3-month Follow-up)
- Change in sleep problems (score at the Pittsburgh Sleep Quality Index)(Pretest / 12-week posttest / 3-month Follow-up)
- Change in Psychological Well-Being (score at the Psychological Well-Being Scales)(Pretest / 12-week posttest / 3-month Follow-up)
- Change in Satisfaction with Life (score at the Satisfaction with Life Scale)(Pretest / 12-week posttest / 3-month Follow-up)
- Change in Grief-Related Avoidance (score at the Grief-Related Avoidance Questionnaire)(Pretest / 12-week posttest / 3-month Follow-up)
研究者
Debrot Anik
Principal Investigator
University of Lausanne