Article Text

Original research
Effects of a mindfulness-based and acceptance-based group programme followed by physical activity for patients with fibromyalgia: a randomised controlled trial
  1. Trond Haugmark1,2,
  2. Kåre Birger Hagen1,3,
  3. Sella Aarrestad Provan1,
  4. Geir Smedslund1,3,
  5. Heidi A Zangi1,4
  1. 1Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Oslo, Norway
  2. 2Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway
  3. 3Division of Health Services, Norwegian Institute of Public Health, Oslo, Norway
  4. 4Faculty of Health, VID Specialized University, Oslo, Norway
  1. Correspondence to Trond Haugmark; trond.haugmark{at}


Introduction Non-pharmacological approaches are recommended as first-line treatment for patients with fibromyalgia. This randomised controlled trial investigated the effects of a multicomponent rehabilitation programme for patients with recently diagnosed fibromyalgia in primary and secondary healthcare.

Methods Patients with widespread pain ≥3 months were referred to rheumatologists for diagnostic clarification and assessment of study eligibility. Inclusion criteria were age 20–50 years, engaged in work or studies at present or during the past 2 years, and fibromyalgia diagnosed according to the American College of Rheumatology 2010 criteria. All eligible patients participated in a short patient education programme before inclusion and randomisation. The multicomponent programme, a 10-session mindfulness-based and acceptance-based group programme followed by 12 weeks of physical activity counselling was evaluated in comparison with treatment as usual, that is, no treatment or any other treatment of their choice. The primary outcome was the Patient Global Impression of Change (PGIC). Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life and work ability at 12-month follow-up.

Results In total, 170 patients were randomised, 1:1, intervention:control. Overall, the multicomponent rehabilitation programme was not more effective than treatment as usual; 13% in the intervention group and 8% in the control group reported clinically relevant improvement in PGIC (p=0.28). No statistically significant between-group differences were found in any disease-related secondary outcomes. There were significant between-group differences in patient’s tendency to be mindful (p=0.016) and perceived benefits of exercise (p=0.033) in favour of the intervention group.

Conclusions A multicomponent rehabilitation programme combining patient education with a mindfulness-based and acceptance-based group programme followed by physical activity counselling was not more effective than patient education and treatment as usual for patients with recently diagnosed fibromyalgia at 12-month follow-up.

Trial registration number BMC Registry (ISRCTN96836577).

  • rheumatology
  • rehabilitation medicine
  • primary care

Data availability statement

No data are available.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

No data are available.

View Full Text

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.


  • Contributors KBH and HAZ contributed to the initial design of the project, and all authors contributed to the conception of the study. Material preparation, data collection and analysis were performed by TH, SAP and GS. All authors contributed to the interpretation of the data. The first draft of the manuscript was written by TH and all authors commented and revised previous versions of the manuscript. All authors read and approved the final manuscript.

  • Funding This work was supported by the Norwegian South-Eastern Regional Health Authority (grant number 2016015).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.