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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in complicated grief symptoms
研究概览
简要总结
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).
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in complicated grief symptoms
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in the monitoring of the mood, solitude feelings and grief symptoms(Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Change in grief coping strategies(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(12-week post-test)
- Indicators of verbal immediacy (use of first-person pronouns and present tense words) and so-called "we-talk" (first-person plural pronouns)(12-week Post-test)
- Change in anxiety symptoms(Pretest; 12-week post-test; 3-month Follow-up)
- Change in aspects related to identity(Pretest; 12-week post-test; 3-month Follow-up)
- Degree of required guidance in each group(12-week Post-test)
研究者
Debrot Anik
Sponsor-Investigator
University of Lausanne