Effects of a community-based multicomponent rehabilitation programme for patients with fibromyalgia: protocol for a randomised controlled trial.
Study Goal
The researchers aimed to investigate the effects of a community-based multicomponent rehabilitation program, including mindfulness-based intervention, on fibromyalgia patients' symptoms and quality of life.
Results Summary
The study design suggests potential benefits of mindfulness combined with physical activity counseling for fibromyalgia patients, but specific results are not yet reported as the trial is ongoing.
Population
Adults aged 20-50 with fibromyalgia, who have been working part-time or full-time in the last 2 years.
Effective Dosage
10 weekly 4-hour group sessions plus a booster session after 6 months.
Duration
10 weeks of intervention plus 12 weeks of physical activity counseling, with follow-up at 12 months.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | Patient Global Impression of Change | People with fibromyalgia (FM) | - | investigate the effects of | #1 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | self-reported pain | People with fibromyalgia (FM) | - | investigate the effects of | #2 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | fatigue | People with fibromyalgia (FM) | - | investigate the effects of | #3 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | sleep quality | People with fibromyalgia (FM) | - | investigate the effects of | #4 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | psychological distress | People with fibromyalgia (FM) | - | investigate the effects of | #5 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | mindfulness | People with fibromyalgia (FM) | - | investigate the effects of | #6 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | health-related quality of life | People with fibromyalgia (FM) | - | investigate the effects of | #7 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | physical activity | People with fibromyalgia (FM) | - | investigate the effects of | #8 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | work ability | People with fibromyalgia (FM) | - | investigate the effects of | #9 |
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling | neutral | exercise beliefs and habits | People with fibromyalgia (FM) | - | investigate the effects of | #10 |
INTRODUCTION: People with fibromyalgia (FM) suffer from symptoms such as widespread pain, non-refreshing sleep, fatigue and reduced quality of life. Effects of pharmacological treatment are questionable and non-pharmacological treatments are recommended as first-line therapy. To date the majority of patients with FM in Norway are not offered any targeted treatment. The aim of this randomised controlled trial is to investigate the effects of a community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling. MATERIALS AND METHODS: General practitioners refer potential participants to a rheumatologist in specialist healthcare for diagnostic clarification and assessment of comorbidities. Inclusion criteria are widespread pain/FM ≥3 months, age 20-50 and work participation (minimum part-time) within the last 2 years. The intervention group attends the VTP comprising 10 weekly 4 hour group sessions plus a booster session after 6 months. Thereafter, they receive 12 weeks of individually tailored physical exercise counselled by physiotherapists at community-based Healthy Life Centers. The control group follows treatment as usual. The primary outcome is Patient Global Impression of Change. Secondary outcomes include self-reported pain, fatigue and sleep quality, psychological distress, mindfulness, health-related quality of life, physical activity, work ability and exercise beliefs and habits. To achieve a power of 80% and allow for 10% dropout, 70 participants are needed in each arm. All analyses will be conducted on intention-to-treat bases and measured as differences between groups at 12 months follow-up. ETHICS AND DISSEMINATION: The study is approved and granted by the Norwegian South-Eastern Regional Health Authority (reference 2016015). Ethics approval was obtained from Regional Committee for Medical and Health Research Ethics (reference 2015/2447/REK sør-øst A). Results will be submitted to appropriate journals and presented in relevant conferences and social media. TRIAL REGISTRATION: ISRCTN 96836577.