Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean of Psychological flexibility scores
研究概览
简要总结
Introduction: emotional and physical alterations frequently appear in cancer patients. In this sense, interventions based on acceptance and commitment therapy (ACT) show their efficacy to improve these symptoms through increased psychological flexibility, however, there is little evidence of the efficacy of ACT using combined modality (face-to-face + app), despite the fact that this application modality may have beneficial effects in this group of patients, who may see their participation in the interventions limited as a consequence of the disease.
Method / design: Cancer patients will be randomly assigned to one of the following groups: (1) face-to-face ACT + app group, (2) face-to-face ACT group, and (3) group receiving usual treatment. The planned interventions last between 8 and 10 weeks and include experiential exercises, metaphors, discussions, and homework assignments to promote awareness and flexibility about thoughts and emotions associated with cancer. In the group that uses the app, exercises (mindfulness, breathing), reminder systems, recording, reinforcement and monitoring will also be provided. It is estimated that a total of 112 participants (38 per group) will be necessary, and four evaluations will be carried out: T0 (pre-treatment), T1 (post-treatment, T2 (follow-up at three months) and T3 (follow-up at six months). months).
Hypothesis : The primary results that are expected to be obtained are a significant increase in the psychological flexibility of patients receiving treatment, with greater flexibility in the group receiving the combined intervention, evaluated with the AAQ-II. Furthermore, as secondary outcomes, it is expected to obtain significant improvements in anxiety and depression (HADS), quality of life (EORTC QLQ C-30), Fatigue (BFI), Insomnia (ISI) and post-traumatic growth (PTGI-SF).
Hypothesis: the efficacy of the ACT-based intervention in cancer patients may be increased if the benefits of using a modality that combines face-to-face and not face-to-face are added to it.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for participants are:
- •Men and women, aged between 18 and 70 years.
- •Cancer diagnosis, stages I-III.
- •Cancer type: Breast / Lung / Colorectal.
- •Eligible for or currently receiving cancer treatment.
- •Ability to be fluent in Spanish.
- •Have a smartphone with daily access and basic smartphone / application management skills.
- •Access to email account and internet.
- •Not currently participating in another clinical trial.
- •Not currently receiving other psychological treatment.
排除标准
- •for participants in the trial:
- •Men and women aged> 70 years.
- •Diagnosis of cancer, stage IV or other types of cancer.
- •Not eligible for treatment.
- •Inability to handle himself fluently in Spanish.
- •Not having a smartphone with daily access and basic smartphone / application skills.
- •Not having access to an email account and the internet.
- •Currently participating in another clinical trial.
- •Currently receiving other psychological treatment.
研究组 & 干预措施
ACT face-to-face + app
Combines face-to-face ACT sessions with non-face-to-face activities and resources (mobile applications)
干预措施: Acceptance and commitment therapy + app (Behavioral)
ACT face-to-face
face-to-face ACT sessions
干预措施: Acceptance and commitment therapy (Behavioral)
Waitlist
Waitlist group. After the second assessment of the two ACT groups (at post-treatment) this group will receive the face to face ACT intervention.
结局指标
主要结局
Mean of Psychological flexibility scores
时间窗: Change of mean scores of psychological flexibility from baseline to immediately after intervention
Acceptance and Action Questionnaire- II (AAQ-II). This instrument is designed to assess experiential avoidance and psychological inflexibility through 7 items that are answered with a Likert-type scale from 1 (never true) to 7 (always true) and a higher score indicates greater experiential avoidance (Bond et al., 2011).
次要结局
- Mean of Fatigue scores(Change of mean scores of fatigue from baseline to immediately after intervention)
- Mean of Anxiety and Depression scores(Change of mean scores of anxiety and depression from baseline to immediately after intervention)
- Mean of Quality of Life scores using EORTC QLQ C-30(Change of mean scores of the different subscales of quality of life from baseline to immediately after intervention)
- Mean of Insomnia scores(Change of mean scores of insomnia from baseline to immediately after intervention)
- Mean in Post-Traumatic growth scores(Change of mean scores of post-traumatic growth from baseline to immediately after intervention)
研究者
Francisco Garcia Torres
Lecturer
Universidad de Córdoba