Comparing the Effectiveness of Acceptance and Commitment Therapy and Cognitive Behavioral Stress Management on Fear of Recurrence, Quality of Life, Psychological Distress, and Fatigue of Caregivers of Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Fear of Cancer Recurrence Inventory-caregiver (FCRI-c)
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of cognitive-behavioral stress management (CBSM) and acceptance and commitment therapy (ACT) on the fear of recurrence, quality of life, psychological distress, and fatigue of caregivers of cancer patients.
Researchers compare the effectiveness of CBSM and ACT to a Control(without receiving intervention) to see if treatment works to improve the health of caregivers of cancer patients. A comparison between the two treatments was also conducted to determine if there was a difference in their effectiveness.
Participants:
In this study, 66 participants were randomly assigned to one of three groups: the CBSM group, the ACT group, or the control group.
The CBSM and ACT groups each attended eight 90-minute, in-person sessions twice a week.
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
- •To be included in the study, caregivers had to be 18 years or older, literate, and provide informed consent. A key requirement was that participants either lived with the patient or visited them at least twice a week.
排除标准
- •Exclusion criteria were applied to ensure the integrity of the study. Participants were excluded if they missed more than two sessions, were currently receiving other psychological interventions, had a major psychiatric or cognitive disorder that would prevent them from providing informed consent, or if the patient passed away.
研究组 & 干预措施
Cognitive Behavioral Stress Management (CBSM)
Participants in this group receive Cognitive Behavioral Stress Management (CBSM)
干预措施: Cognitive Behavioral Stress Management (CBSM) (Behavioral)
Acceptance and Commitment Therapy (ACT)
Participants in this group receive Acceptance and Commitment Therapy (ACT)
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Control
The control group receives no intervention.
结局指标
主要结局
Fear of Cancer Recurrence Inventory-caregiver (FCRI-c)
时间窗: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.
This scale, developed by Lin et al., (2018), consists of 42 items measured on a 5-point Likert scale, encompassing seven subscales related to triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping Strategy.
Depression Anxiety and Stress (DASS)
时间窗: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.
This scale, developed by Lovibond and Lovibond (1995), consists of 21 items measured on a 4-point Likert scale, encompassing three subscales for depression, anxiety, and stress.
Caregiver Quality of Life-Cancer (CQOLC)
时间窗: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.
This scale, developed by Weitzner et al., (1999), consists of 35 items measured on a 5-point Likert scale, encompassing four subscales for burden, disruptiveness, positive adaptation, and financial concern, along with eight additional items.
Multidimensional Fatigue Inventory (MFI)
时间窗: assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up.
This scale, developed by Smets et al., (1995), consists of 20 items measured on a 5-point Likert scale, encompassing five subscales: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
次要结局
未报告次要终点
研究者
Fatemeh Al-Sadat Hosseini
Msc Psychology
Ardakan University