Technology-supported Interventions for Prolonged Grief Disorder in Adults a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Change in the Inventory of Complicated Grief (ICG).
研究概览
简要总结
The main aim of this project is to test the efficacy of two formats of delivering an internet- based treatment(GROw) for Prolonged Grief Disorder (PGD) in order to enhance treatment adherence: in a blended format (that combines self-applied treatment online with face-to face sessions with a therapist by videoconference: BF-GROw) and self-applied online format supported by Ecological Momentary Assessment (EMAs) and Ecological Momentary Interventions (EMIs) (iGROw), compared with a waiting list (WL) control group in a community sample of patients with the diagnosis of PGD. The general initial hypothesis is that both treatment conditions (blended format and self-applied format supported by EMAs and EMIs) will significantly produce an improvement in grief symptoms, compared to the WL control group.
详细描述
The grieving process is defined as a painful response, including cognitive, emotional and behavioural components, following the death of a loved one. This response of unique intensity and duration for each individual may involve symptoms such as intense emotions, worry, memories of the deceased and a decrease in activity, which will diminish over time. However, it is estimated that 10% of the population who experience the death of a loved one eventually develop prolonged grief disorder (PGD). There are now evidence-based psychological treatments that are effective in treating PGD. However, 70% of people who need them do not receive them. According to the scientific literature, self-administered technology-supported interventions have been developed to treat this problem and have demonstrated multiple benefits. This study aims to test the efficacy and efficiency of different treatment options that exist for this disorder through a randomized controlled trial. Participants will be adults with a diagnosis of PGD, according to ICD-11 criteria for PGD (WHO,2018) and will be randomly distributed into three groups: 1) blended intervention (BF-Grow group); 2) self-applied intervention supported by EMAs and EMIs (iGrow group); and 3) waiting-list group (WL control group). Both treatment groups will receive the same treatment (GROw) consisting of 8 modules: 1. Welcoming, 2. Understanding reactions to loss, 3. Coping with loss, 4. Loss integration and restoration (first steps), 5. Deepening integration and restoration of loss, 6. Consolidating loss integration and restoration, 7. Self-care, guilt and forgiveness in the grieving process and 8. Evaluating progress and looking to the future.
On the one hand, group 1 (BF-Grow) will receive a treatment module every 10-12 days and in addition an individual session of approximately 30 minutes with a therapist. On the other hand, group 2 (iGrow) will carry out the entire intervention on a self-applied basis only and will be able to access the next module 7 days after the start of the previous one. In addition, this condition will be supported by an App which contains EMA and EMI tools. Participants will be evaluated at baseline, post-treatment, and 3- and 12-month follow-ups.
This study will follow the Consolidated Standards for Reporting Trials (CONSORT)statement and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials).
Specific objectives of the study include: examine the efficacy of BF-Grow and iGROw intervention formats compared to a WL group in the post-treatment and In addition, post hoc comparisons will be conducted among the adjusted means of the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Being at least 18 years old.
- •Meeting diagnostic criteria for Prolonged Grieft Disorder based on the International Classification of Diseases 11 edition (ICD-11).
- •Sign an informed consent.
- •Ability to understand and read Spanish.
- •Ability to use a computer.
- •Having an e-mail address.
- •Having an internet connection and Access to a Smartphone.
排除标准
- •Presence of high risk of suicide.
- •Presence of axis I severe mental disorder: substance abuse or dependence, psychotic disorder, dementia, bipolar disorder; severe personality disorder or medical illness whose severity or characteristics prevent treatment.
- •Receiving other psychological treatment during the study.
- •An increase and/or change in the medication during the study period, in the case of receiving pharmacological treatment.
结局指标
主要结局
Change in the Inventory of Complicated Grief (ICG).
时间窗: Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment
The Inventory of Complicated Grief (ICG) is a self-administered instrument that assesses grief symptoms in adults. It is a simple instrument that allows distinguishing normal grief reactions from complicated ones.The instrument consists of 19 items written in the first person with five response options (Likert): 0; never 1; rarely 2; sometimes 3; often and 4; always. about the client's thoughts and behaviors related to immediate grief. The items assess the frequency of emotional, cognitive and behavioral symptoms characteristic of the grieving process.
次要结局
- Change in Beck Depression Inventory-II (BDI-II).(Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.)
- Change in Typical Beliefs Questionnaire (TBQ).(Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.)
- Change in Overall Anxiety Severity and Impairment Scale (OASIS).(Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.)
- Change in Overall Depression Severity and Impairment Scale (ODSIS).(Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.)
- Change in Short-Form of the International Positive and Negative Affect Schedule (iPANAS).(Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.)