Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) - an Open Case Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ME/CFS Disability Index (changes between assessments)
研究概览
简要总结
The goal of this research project is to evaluate if our well-researched behavior medicine treatment model for chronic pain, based on Acceptance and Commitment Therapy, is safe and effective in increasing quality of life and functioning also in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). To date there are no effective treatments for ME/CFS as the ethology and pathophysiology are unknown, while levels of functioning and quality of life as well as secondary effects such as depressive and anxiety symptoms indicate a highly affected patient population. As such, there is a need for behavior medicine approaches that aim to alleviate suffering and promote increases in quality of life for these patients. The aim of the present study is to do a preliminary evaluation of the safety, acceptability and efficacy of an ACT-based treatment protocol for ME/CFS. An additional aim is to explore potential mediators of change for the effect of treatment on disability.
详细描述
Background Medical strategies alone appear insufficient to increase functioning and quality of life in ME/CFS. Cognitive behavioral therapy (CBT) is the only treatment approach with preliminary evidence of efficacy for improving functioning and quality of life. However, effect sizes are generally modest.
Behavior medicine treatment approaches based on Acceptance & Commitment Therapy (ACT) have gained increasing attention and research support within clinical trials for similar diagnoses (e.g. chronic pain, Fibromyalgia). Results from these areas illustrate the utility of this approach for individuals with somatic symptomatology. To date, the efficacy of ACT has not been evaluated for ME/CFS.
Purpose The aims of this pilot study are to explore the utility of ACT and to evaluate the feasibility of the treatment model for patients with ME/CFS.
Method Treatment program: 13 weekly to bi-weekly individual ACT sessions with a psychologist (10) and a physician (3) respectively.
An open trial design is used, with assessments at pre-, mid- and post-treatment as well as at 3 and 6 months follow-up. Further, yearly follow-ups until 5-year follow-up are planned.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects were included if
- •Referred to a specialist behavior medicine treatment unit for ME/CFS
- •18 years of age or older
- •Fulfilling CDC ME/CFS diagnostic criteria AND 2003 clinical case definition ME/CFS diagnostic criteria
- •Treatment resistent symptomatology
- •Evident ME/CFS-related disability (assessed with self-report questionnaires and clinical interviews)
- •Stabile medication during the last 2 months with no planned changes during active study treatment
排除标准
- •Subjects were excluded if:
- •psychiatric or somatic comorbidity was prevalent and assessed as more primary than ME/CFS illness;
- •non-adherence during assessment phase;
- •they did not speak Swedish;
- •ongoing or recently (less than six months) completed CBT-oriented treatment;
- •other treatment than standard care (pharmacological, psychological or otherwise) planned in the coming six months
研究组 & 干预措施
ACT
Acceptance & Commitment Therapy (ACT)
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
结局指标
主要结局
ME/CFS Disability Index (changes between assessments)
时间窗: Baseline to 6-month follow-up
Self-reported ME/CFS-related disability in 7 life domains (domestic; recreational activities; social activities; occupational; sexual life; daily activities; life-sustaining activities). Each item is scored 0-10 (0= no disability, 10=total disability).
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)
时间窗: Baseline to 6-month follow-up
Self-rated psychological inflexibility related to fatigue
次要结局
- ME/CFS Symptoms (changes between assessments)(Baseline to 6-month follow-up)
研究者
Rikard Wicksell
Associate Professor
Karolinska Institutet