Adaptation of a Psychological Therapy for Patients With ALS - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Patient adherence
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is a disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. This pilot study will test a manualized, individual psychotherapeutic intervention to relieve distress and promote psychological well-being in ALS patients. A total of 5 patients will receive the intervention. The investigators will gather important information regarding the feasibility of the intervention (i.e., response rate, patient and therapist adherence, and patient satisfaction), which may be used for conducting a future randomized controlled trial. Various domains of quality of life will be assessed before the intervention (T0), after the intervention (T1) and at 3-months-follow-up (T2) in order to test for preliminary efficacy of the intervention.
详细描述
Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. ALS patients have to face a rapidly debilitating physical decline which restrains mobility and impairs all activities of daily living. In addition, they are confronted with their own mortality. This progressive loss of autonomy and fears about the future may lead to a sense of hopelessness and loss of quality of life, which in turn may even result in thoughts about physician-assisted suicide.
Concrete aims: Given the high emotional strain in this patient group, this study aims to apply a manualized psychotherapeutic intervention to relieve distress and promote psychological well-being on ALS patients. This short-term intervention (up to six sessions) was originally developed for advanced cancer patients. "Managing Cancer and Living Meaningfully (CALM)" focuses on the four dimensions: (i) symptom management and communication with healthcare providers, (ii) changes in self and relations with close others, (iii) spirituality, sense of meaning and purpose and (iv) thinking of the future, hope, and mortality.
Methodology: For these aims mentioned above, the investigators will conduct a feasibility study, i.e., a pilot study before a future randomized controlled trial can be planned in detail. The design of this pilot intervention will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group (n = 5) that receives the intervention (IG). No control group will be recruited. Assessments will be conducted on the three measurement points: before the therapy (T0), after the intervention (T1) and 3 months after the intervention (T2).This study is intended to test out the standard operating procedures, evaluate the feasibility, acceptance and adherence to the study protocol as well as preliminary efficacy of the intervention.
Recruitment: Patients will be consecutively recruited in the Clinic of Neurology at the University Medical Center of Leipzig.
Duration: The duration for patients will be about 9 months (6 months intervention, 3 month-follow-up assessment). The duration of the whole study will be 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •confirmed diagnosis of Amyotrophic Lateral Sclerosis
- •minimum age of 18 years
- •fluent in German language
- •ability to visit the institution providing the intervention at the start of therapy (in the course of treatment, telephone-sessions may be offered)
- •ability to report on thoughts and feelings (by speaking, writing or via communication devices)
- •cognitive ability to give written informed consent
- •expected remaining lifetime of at least 9 months
排除标准
- •inability for communicate (neither via speaking, writing or communication devices)
- •currently in psychotherapeutic treatment
结局指标
主要结局
Patient adherence
时间窗: During the intervention phase for each patient, which will be about sixth months.
Patient adherence will be assessed via documentation of patient drop-outs. In detail, we will document whether patients leave the study during the treatment (and if yes, at what stage).
Patient satisfaction
时间窗: Assessed only once for each patient, immediately after the patient has completed the intervention.
Assessed by a questionnaire (Working Alliance Inventory - short form revised). The total sum score across the 12 items, rated on a five-point Likert scale, will be presented (ranging from 12 to 60). Higher values present higher satisfaction.
Response rate
时间窗: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
次要结局
- Level of depressive symptomatology(Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention)
- Level of functioning(Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention)
- Level of quality of life(Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention)
研究者
Anja Mehnert
Head of the Department of Medical Psychology and Medical Sociology
University of Leipzig