Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): An Open Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in the Inventory of Complicated Grief (ICG) validated in the Spanish population
研究概览
简要总结
The purpose of this study is to investigate the feasibility, acceptability and preliminary efficacy of an internet delivered cognitive behavior treatment (ICBT) for people with prolonged grief disorder (PGD) compared to a face-to-face intervention for PGD.
详细描述
Grief is an intense emotional reaction to the loss of a loved one. It produces feelings of regret and longing that usually decrease over time. However, some people have difficulty adapting to the loss and develop Prolonged Grief Disorder (PGD). An open clinical trial will be conducted to investigate the feasibility [initial efficacy and acceptability] of an Internet delivered cognitive behavior treatment (ICBT) for adult people diagnosed with prolonged grief disorder (PGD). There will be at least 24 participants that will be randomly assigned to experimental group (internet-based treatment for PGD) or active control group (traditional face- to-face intervention for PGD). Four assessment moments will be included (pre-treatment, post-treatment, 3 months follow-up and 12 months follow-up). The present study aims to improve knowledge about the feasibility, acceptability and preliminary efficacy of an ICBT for PGD and conduct a preliminary comparison between two intervention conditions (internet-based intervention vs. traditional face-to-face intervention). Also, the investigators aim to collect information that can help to improve the efficacy and acceptability of Internet-based interventions in general.
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
- 否
入选标准
- •Age ≥ 18 years
- •Meeting diagnostic criteria for PGD
- •Sign an informed consent
- •Ability to understand and read Spanish
- •Ability to use a computer and having access to the Internet
- •Having an e-mail address
排除标准
- •Presence of risk of suicide or self-destructive behaviors
- •Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia o bipolar disorder)
- •Presence of severe personality disorder
- •Presence of a medical condition whose severity or characteristics prevent the performance of treatment
- •Receiving other psychological treatment during the study for PGD
- •An increase and/or change in the medication during the study period
结局指标
主要结局
Change in the Inventory of Complicated Grief (ICG) validated in the Spanish population
时间窗: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
It is a self-applied instrument that assesses grief symptoms in adults. Good psychometric properties; cronbach's alpha of0.94 in the original version and 0.88 in the Spanish adaptation. It consists of 19 items with five response categories (Likert): 0; never 1; rarely 2; sometimes 3; often and 4; forever. The items value the frequency of the symptom explored (emotional, cognitive or behavioral). It is completed in approximately 10 minutes. The total score is calculated by adding the score of the 19 items. The total score ranges from 0 to 76, with highest scores corresponding to a greater probability of suffering complicated grief.
Change in the Beck Depression Inventory - Second Edition validated in the Spanish population
时间窗: immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment
It is a self-applied instrument that assesses characteristic attitudes and symptoms of depression. Psychometric properties; Cronbach's alpha of 0.76 to 0.95 and test-retest reliability of around 0.8. It consists of 21 items that are scored on a scale from 0 to 3. It is calculated by adding the score of the 21 items and the maximum total score is 63.
次要结局
- Change in the Overall Depression Severity and Impairment Scale (ODSIS) validated in the Spanish population(immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in the Work and Social Adjustment Scale (WSAS) validated in Spanish language(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in the Positive and Negative Affect Schedule (PANAS) validated in the Spanish population(immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in Purpose-In-Life Test (PIL- 10)(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in the Overall Anxiety Severity and Impairment Scale (OASIS) validated in the Spanish population(immediately pre-treatment, weekly during treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in the Quality of Life Index (QLI) validated in Spanish language(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in the Posttraumatic Growth Inventory (PTGI) validated in Spanish language(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in Typical Beliefs Questionnaire (TBQ)(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in Five-Facet Mindfulness Questionnaire (FFMQ-15) validated in Spanish population(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)
- Change in Self-Compassion Scale Short Form (SCS-SF) validated in Spanish population(immediately pre-treatment, immediately post-treatment, 3-month post-treatment, 12-month post-treatment)