The Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Symptoms of prolonged grief disorder
研究概览
简要总结
While most bereaved individuals cope adaptively with the loss of a loved one, a significant minority experiences more severe and complicated grief reactions. Complicated grief reactions is an umbrella term for different types of post-loss complications, including symptoms of Prolonged Grief Disorder (PGD), depression, anxiety, and posttraumatic stress. These post-loss complications may all cause persistent suffering and functional impairment, thus pointing to a need for efficacious treatment.
While Cognitive Behavioural Therapy (CBT) is a relatively well-documented efficacious treatment for symptoms of PGD, depression, anxiety, and posttraumatic stress in the period after a loss, the relative efficacy of a transdiagnostic individually delivered versus group-based CBT for these types of complicated grief reactions (CBTgrief) remain unknown. Furthermore, little evidence exists about the relative cost-effectiveness of individually delivered versus group-based CBTgrief and why and how it works. The theory of CBTgrief proposes that it works by targeting three maintaining mechanisms in PGD: 1) Insufficient integration of the loss, 2) negative loss-related cognitions, and 3) depressive and anxious avoidance. These maintaining mechanisms have also shown to be statistically associated with depression, anxiety, and posttraumatic stress in the period after a loss, suggesting that different types of complicated grief reactions might share some of the same maintaining mechanisms. However, this proposed theory of change has yet to be empirically tested as a whole.
These knowledge gaps are crucial for the understanding of efficacious and cost-effective treatment formats as well as central treatment mechanisms in the psychological treatment of complicated grief reactions. The present study thus aims to examine the relative efficacy of an individually delivered versus group-based CBTgrief by means of a randomized non-inferiority trial. Secondary aims include an investigation of the relative cost-effectiveness of individually delivered versus group-based CBTgrief as well as treatment mediators. Finally, explorative analyses of potential moderators of intervention effects of CBTgrief will be conducted.
详细描述
Aims of the study:
- Evaluate the relative efficacy of an individually delivered versus group-based CBTgrief.
- Evaluate the relative cost-effectiveness of an individually delivered versus group-based CBTgrief.
- Examine the theoretically proposed treatment mediators of CBTgrief.
- Explore loss-related and sociodemographic characteristics as possible moderators of intervention effects.
Primary hypothesis:
Group-based CBTgrief will show non-inferiority (i.e., equal efficacy) in reducing symptoms of PGD compared to individually delivered CBTgrief at six months follow-up.
Secondary hypotheses:
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
盲法说明
However, the investigator, therapists, and participants are masked in terms of not knowing which treatment the participants will be randomized to until after the completion of baseline assessment (T1).
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years (older adult).
- •Lost a loved one (e.g., spouse, partner) ≥ 6 months ago.
- •Clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief (PG-13 ≥ 29), depression (CESD-10 ≥ 10), anxiety (GAD-7 ≥ 10), and/or posttraumatic stress (PCL ≥ 31)).
排除标准
- •No clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief, depression, anxiety and/or posttraumatic stress).
- •No informed consent given.
- •Insufficient Danish proficiency.
- •Inability to transport oneself to the clinic.
- •Severe psychopathology (e.g., schizophrenia).
- •Severe cognitive impairment (e.g., Alzheimer's disease).
- •Substance abuse.
- •Acute suicidal ideation.
结局指标
主要结局
Symptoms of prolonged grief disorder
时间窗: From baseline (T1) to post-intervention (T3; up to one week after the 12th session) and to six months follow-up (T5).
Changes in symptoms of prolonged grief disorder will be measured with Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009). Higher total scores indicate higher symptom level (minimum value: 11; maximum value: 57).
次要结局
- Anxiety symptoms(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Posttraumatic stress symptoms(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Symptoms of ICD-11 prolonged grief disorder(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Depressive symptoms(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Functional impairment(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Symptoms of prolonged grief disorder (at three months follow-up)(From baseline (T1) to three months follow-up (T3).)
- Quality adjusted life years(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Social support(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Well-being(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Loneliness(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)
- Mental and physical function(From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).)