Psychological Treatment for Persistent Fatigue: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Working alliance
研究概览
简要总结
This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue.
详细描述
Previous research indicates that fatigue is a transdiagnostic symptom dimension rather than a disorder-specific pathofysiology. Similar psychosocial mechanisms can contribute to the development and perpetuation of fatigue across medical conditions. Cognitive and behavioral interventions targeting these perpetuating mechanisms have been found effective in reducing fatigue severity and functional impairment in a range of different fatigue-dominated diagnostic groups. Based on these findings, the investigators have developed a transdiagnostic intervention for primary care patients who suffer from persistent fatigue, independent of primary diagnosis. The treatment is a psychological intervention based on cognitive and behavioral principles that is administered over a period of 4-6 months. Treatment material will be delivered via an online treatment platform and therapist support will be given both face-to-face and via written asynchronous text-messages in the online treatment platform.
This initial feasibility study is non-randomized, meaning that all included patients will recieve treatment.
The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions. If the inclusion procedure, the data-collection procedure, and the treatment are feasible, a larger randomized clinical trial (RCT) studying treatment effect is called for. An adequately powered RCT could provide firm scientific support for a novel, scalable, and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group. This would have a desirable impact on patients, families, healthcare units, and society at large, given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe, functionally disabling fatigue as a central symptom for at least 3 months
- •The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication
- •regular access to a computer and to the Internet
- •ability to read and write in Swedish.
排除标准
- •substance abuse disorder in the past 6 months
- •Current or past psychosis or bipolar disorder
- •Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder)
- •elevated risk for suicide
- •anorexia nervosa
- •Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month
- •ongoing chemotherapy
- •intellectual disability (e.g., severe autism) that affects ability to work with the treatment
- •life circumstances that complicate or make treatment impossible (e.g., domestic violence or ongoing legal disputes)
- •ongoing psychological treatment and/or multimodal rehabilitation.
结局指标
主要结局
Working alliance
时间窗: Week 3 and 15 of treatment
Assessed using the Working Alliance Questionnaire (WAI - short version). Scale range is from 6 to 42 with higher scores indicating a better percieved working alliance.
Treatment adherence and completion
时间窗: Post-treatment (6 months)
Treatment adherence will be assessed by evaluating how many sessions (face-to-face and video-based) the patient received, how many modules of the internet-delivered material the patient accessed, and the amount of time the patient spent in the online treatment platform (data extracted from the platform). Further, number of drop-outs (i.e., patients who discontinued treatment before treatment completion) will be analyzed
Patient satisfaction
时间窗: Post-treatment (6 months)
Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction.
Treatment credibility
时间窗: Three weeks after treatment start
Assessed using the Credibility/Expectancy Questionnaire (C-Scale). The C-Scale is a 5-item measure, scale range is 0 to 50 points with higher scores indicating higher treatment credibility.
Negative effects of treatment
时间窗: Post-treatment (6 months)
The Negative Effects of Treatment Questionnaire (NEQ-20). The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0).
Open-ended questions regarding treatment content and presentation
时间窗: Post-treatment (6 months)
Post-treatment, patients will be asked open-ended questions regarding their perception of the different components of the treatment, how much time they spent working with the treatment, and their thoughts about the usability of the digital platform.
次要结局
- Somatic symptoms(Assessed pre- and at post treatment (6 months))
- Perceived Stress(Assessed pre- and at post treatment (6 months))
- Feasibility of study inclusion procedures and data-collection(Data will be collected during the recruitment and inclusion phase of the study.)
- Depressive symptoms(Assessed pre- and at post treatment (6 months). The individual item assessing suicide risk will be administered every 3 weeks during the traetment phase.)
- Fatigue severity, primary self-rated symptom outcome(Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.)
- Reduced physical activity(Assessed pre- and at post treatment (6 months))
- Self-rated health(Assessed pre- and at post treatment (6 months))
- Problems concentrating(Assessed pre- and at post treatment (6 months))
- Reduced motivation(Assessed pre- and at post treatment (6 months))
- Burnout(Assessed pre- and at post treatment (6 months))
- Insomnia(Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.)
- Cognitive and behavioral responses to symptoms(Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.)
- General anxiety(Assessed pre- and at post treatment (6 months))
- General self-efficacy(Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.)
- Functional disability(Assessed pre- and at post treatment (6 months))
- Work and Social Adjustment(Assessed pre- and at post treatment (6 months))
研究者
Elin Lindsäter
clinical psychologist, PhD, Principal Investigator
Karolinska Institutet