Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Penn State Worry Questionnaire
研究概览
简要总结
Informal caregivers of cancer patients report high levels of psychological distress as evidenced in markedly increased levels of anxiety and depression. High levels of psychological distress in caregivers have also been found to be associated with poorer health and increased levels of pro-inflammatory cytokines that are well-established risk factors for physical illness and stress-related mortality. Previous psychological interventions using cognitive methods have only produced small effect sizes and more research on how to effectively alleviate caregiver burden is needed. The proposed project will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel approach specifically targeting emotion regulation with the aim of improving mental and physical health. The effect of ERT will be examined in a randomized controlled trial comparing ERT to usual medical care (UMC).
详细描述
PURPOSE:
The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT) for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and consists of 8 weekly sessions.
AIMS AND HYPOTHESES:
Intervention and mediation effects. In an RCT, the investigators will investigate the efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a) significant reductions in psychological distress and perceived caregiving burden, 1b) improvements in quality of life; and 1c) improvements in pro-inflammatory markers of stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report 2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic inflammation. Due to the design, these effects will be considered following the acute treatment period (pre, mid and post therapy). In addition to this, gains are expected to be maintained over the follow-up-period. In addition, 3) improvements are exptected to be maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of ERT.
PARTICIPANTS AND PROCEDURES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medium levels of distress (distress thermometer > 3) and at least moderate levels of worry or rumination
- •Caregiver of patient with cancer
排除标准
- •an expected survival of the patient of <6 months,
- •active substance abuse (alcohol or drugs), and
- •participation in other psychosocial trials.
结局指标
主要结局
Change in Penn State Worry Questionnaire
时间窗: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring worry
Change in Rumination Response Scale - Brooding subscale only
时间窗: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring brooding
Change in The Caregiver Reaction Assessment and EORTC-QLQ-30
时间窗: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring burden in ICs and quality of life cancer patients, respectively
Change in Hospital Anxiety and Depression Scale (HADS)
时间窗: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring anxiety and depression
次要结局
- Change in Experiences Questionnaire(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Change in Difficulty in Emotion Regulation Scale(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Change in Emotion Regulation Questionnaire(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Emotional closeness(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Change in Five Facet Mindfulness Questionnaire(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Change in The Pittsburgh Sleep Quality Index(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Change in Pro-inflammatory markers: CRP, TNFalpha, IL-1, IL-6(Between-group effect at post, based on the whole treatment duration (pre-, and post-therapy).)
- Change in quality of life - WHO-5(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)
- Emotional attention coping (EAC)(Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).)