Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: a Protocol Study of a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Meaning in Life Questionnaire (MLQ)
研究概览
简要总结
The aim of this study is to verify the efficacy of the Spanish adaptation of Meaning-Centered Psychotherapy for Spanish participants with cancer in a randomized control trial.
详细描述
Meaning-Centered Psychotherapy (MCP) is effective in improving meaning in life, hope, optimism, self-efficacy, well-being, and quality of life, and in reducing stress in people with cancer. However, all the studies on the application of MCP in cancer patients have been carried out in Anglo-Saxon samples. Therefore, it is necessary to adapt and verify the efficacy of MCP in populations that speak languages other than English, such as Spanish. Moreover, to expand the data supporting the efficacy of MCP for cancer patients, it would be necessary to compare MCP to other active therapies such as Cognitive Behavioral Therapy (CBT). The study has several aims: The first objective is to verify the efficacy of the MCP intervention for Spanish participants with cancer in a randomized control trial (RCT) comparing it to CBT. The second objective is to analyze the feasibility and acceptance of MCP in Spanish participants with cancer. The third objective is to analyze whether the changes produced in the Meaning in Life dimensions (presence, search, comprehension, purpose, and mattering) will predict changes in anxiety, depression, quality of life, etc.
The investigators adapted MCP for Spanish participants with cancer. The Spanish MCP is an adaptation of the MCP developed by Breitbart as an eight-session group therapy for patients with advanced cancer. This paper presents the study protocol. The study design consists of a two-arm RCT with two conditions: MCP and CBT, where participants will be randomized to one of the two groups. Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy). Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy).
- •Participants will have to express a need for psychological care.
- •Participants will have low meaning in life.
排除标准
- •Participants who are currently receiving another psychological or psychiatric treatment.
- •Diagnosis of a serious mental disorder (schizophrenia, substance dependence, dementia, or cognitive impairment).
研究组 & 干预措施
Meaning-Centered Group Psychotherapy (MCP).
The intervention lasts two months and includes eight sessions that follow a two-hour group format on a weekly basis. The investigators will follow the manualized MCP for patients with advanced cancer.
干预措施: Meaning-Centered Group Psychotherapy (MCP). (Behavioral)
Cognitive Behavioral Psychotherapy (CBT).
The intervention lasts two months and includes eight sessions that follow a two-hour group format on a weekly basis, with the following sessions. The investigators will follow the manualized CBT or patients with advanced cancer.
干预措施: Cognitive Behavioral Psychotherapy (CBT). (Behavioral)
结局指标
主要结局
Meaning in Life Questionnaire (MLQ)
时间窗: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
The MLQ is a self-reported questionnaire made up of 10 items, and it was developed to assess the two main dimensions of meaning in life: presence and search for meaning in life. The items are rated on a 7-point scale ranging from 1 (absolutely false) to 7 (absolutely true). The factors of Presence and Search were correlated (r = -.19), and internal consistency was good for Presence (.86) and Search (.87). One-month test-retest reliability coefficients were .70 for Presence and .73 for Search.
The Multidimensional Existential Meaning Scale (MEMS)
时间窗: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
The MEMS assesses the meaning in life dimensions: Comprehension, purpose, and mattering, with a total of 15 items. Likert type responses are given on a 7-point scale (1 = Very strongly disagree; 7 = Very strongly agree). The three MEMS subscales showed adequate internal consistency: Comprehension (ϖ = 91), Purpose (ϖ = 92), and Mattering (ϖ = 86).
次要结局
- Opinion and Expectations of Treatment Scale (OTSM)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Overall Anxiety Severity and Impairment Scale (OASIS)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Overall Depression Severity and Impairment Scale (ODSIS)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Mini-Mental Adjustment to Cancer Scale.(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- The Positive and Negative Affect Schedule (PANAS)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Quality of life index-Spanish version (QLI)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- Hopelessness Scale (HS)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
- The Posttraumatic Growth Inventory (PTGI)(Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.)
研究者
Jose H. Marco
Associate Professor of Phychology
University of Valencia