Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Physical Activity, Psychological Support, and Nature Exposure (NAT-FM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Revised Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
The main objective of this study is to analyse the efficacy of the NAT-FM multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.
In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of NAT-FM treatment in the short- and long-term, the research team will seek to identify relevant moderators and mediators of clinical change.
详细描述
- This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program NAT-FM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone.
- NAT-FM combines Classical Structural Assessment (CSA) and Ecological Momentary Assessment (EMA) to obtain more reliable information about the dynamics of the variables to be evaluated, to record the affective and cognitive impact of each activity, and to explore its potential delivery in real-world clinical practice.
- The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as self-efficacy and pain catastrophizing.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults from 18 to 75 years-old.
- •1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
- •Able to understand Spanish and accept to participate in the study.
排除标准
- •Participating in concurrent or past RCTs (previous year).
- •Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
结局指标
主要结局
Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: Through study completion, an average of 9 months
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.
次要结局
- Tampa Scale for Kinesiophobia (TSK-11)(Through study completion, an average of 9 months)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 9 months)
- Pain Catastrophizing Scale (PCS)(Through study completion, an average of 9 months)
- Personal Perceived Competence Scale (PPCS)(Through study completion, an average of 9 months)
- Perceived Stress Scale (PSS)(Through study completion, an average of 9 months)
- Cognitive Emotion Regulation Questionnaire (CERQ)(Through study completion, an average of 9 months)
- Rosenberg Self-Esteem Scale (RSES)(Through study completion, an average of 9 months)
- Ecological Momentary Assessment (EMA)(Through intervention completion, an average of 3 months)
- Positive and Negative Affect Schedule (PANAS)(Through study completion, an average of 9 months)