Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in the Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.
详细描述
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of Fibromyalgia symptoms and impact. Secondary objectives are to 1) investigate the treatment's ability to reduce degree of a) quality of life b) function c) insomnia and fatigue d) pain-related fear and negative thoughts e) depression and anxiety, cost-effectiveness of this treatment; and 2) to study if any variables could moderate/mediate the treatment outcome, such as a) degree of covert avoidance, b) degree of reactivity to inner sensations
Trial Design: Randomized controlled trial with waitlist control, who also will receive treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in Fibromyalgia symptoms and impact from baseline to Week 10. Long term follow-up is also investigated (potential changes from post-treatment to 6- and 12 months after treatment completion)
Efficacy Parameters: the Fibromyalgia Impact Questionnaire (FIQ)
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia diagnosis
- •Swedish resident
- •Internet connection before, under and after treatment
- •Willing to refrain from other concurrent psychological treatment during the study
- •Agreement to keep psychotrophic medication constant during the study
排除标准
- •Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
- •Ongoing alcohol or substance abuse
- •Psychosis
- •Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; >29 weeks gestation
- •Illiteracy or poor skills in Swedish language
- •Insufficient computer or language skills to manage a text-based treatment.
- •Other concurrent psychological treatment
- •Recent changes in psychotrophic medication (<6 weeks prior to randomization)
结局指标
主要结局
Change in the Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
次要结局
- Fatigue Severity Scale (FSS)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- WHO Disability Assessment Schedule 2.0 (WHODAS 2)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- The Psychological Inflexibility in Pain Scale (PIPS)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Pain Reactivity Scale (PRS)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Insomnia Severity Index (ISI)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Brunnsviken Brief Quality of Life Inventory (BBQ)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Patient Health Questionnaire-9 (PHQ-9)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- EQ5D(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
研究者
Erik Andersson
Med Dr.
Karolinska Institutet