Administrative information
Title {1} | Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial |
Trial registration {2a and 2b} | ClinicalTrials.gov: NCT03766100. Registered on 30 November 2018. |
Protocol version {3} | 15 January 2020. Version 1. |
Funding {4} | The Sleep-RA trial is funded by grants from the Danish Rheumatism Association, Rigshospitalet, Lundbeckfonden, the Novo Nordisk Foundation, Danish Nurses Organization and Toyota-Fonden, Denmark. The Parker Institute, Bispebjerg and Frederiksberg Hospital (RC) is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). |
Author details {5a} | 1 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup , Denmark. 2 Research unit for Cancer Late Effect, Department of Oncology, Rigshospitalet, Copenhagen, Denmark. 3 Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. 4 Danish Center for Sleep Medicine, Department of Clinical Neurophysiology, Rigshospitalet, Glostrup, Denmark. 5 Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark. 6 Research Unit of Rheumatology, Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 7 Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark. 8 The University Hospitals Centre for Health Research, Rigshospitalet, Copenhagen, Denmark. 9 Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. |
Name and contact information for the trial sponsor {5b} | This is an investigator-initiated trial that proceeds from: Copenhagen Center for Arthritis Research Center for Rheumatology and Spine Diseases Rigshospitalet Bente Appel Esbensen Valdemar Hansens Vej 17 2600 Glostrup Denmark + 453,863,863 Bente.appel.esbensen@regionh.dk |
Role of sponsor {5c} | This is an investigator-initiated trial solely funded by non-commercial sources. Funding sources have had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. |
Introduction
Background and rationale {6a}
Rheumatoid arthritis
Insomnia
Treatment of insomnia
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Session 1 | Introduction | Presentation |
Goals | ||
Expectations | ||
Sleep education | Normal sleep and its determinants | |
Sleep needs | ||
Consequences of insomnia | ||
Nature of insomnia | ||
Evaluation of participant sleep | ||
Sleep hygiene | ||
Sleep restriction | Introduce sleep diary | |
Session 2 | Follow-up | Since last session |
Sleep education | Sleep hygiene | |
Stimuli control | Rationale; conditioned arousal | |
Instructions | ||
Sleep restriction | Rationale; sleep drive and sleep consolidation | |
Sleep efficiency and sleep window for week 2 | ||
Relaxation | Bed time wind-down | |
Session 3 | Follow-up | Since last session |
Stimuli control | Experiences and challenges | |
Sleep restriction | Experiences and challenges | |
Sleep efficiency and sleep window for week 3 | ||
Cognitive therapy | Cognitions affecting sleep | |
Cognitive techniques to treat insomnia | ||
Session 4 | Follow-up | Since last session |
Sleep restriction | Experiences and challenges | |
Sleep efficiency and sleep window for week 4 | ||
Cognitive therapy | Experiences and challenges | |
Cognitive techniques to treat insomnia | ||
Worry-time | ||
Relaxation | Rationale, break the tension and return to a relaxed state | |
Body scan meditation | ||
Session 5 | Follow-up | Since last session |
Stimuli control | Experiences and challenges | |
Sleep restriction | Experiences and challenges | |
Sleep efficiency and sleep window for week 5 | ||
Cognitive therapy | Experiences and challenges | |
Cognitive techniques to treat insomnia | ||
Relaxation | Experiences and challenges | |
Session 6 | Follow-up | Since last session |
Sleep restriction | Experiences and challenges | |
Sleep efficiency and sleep window for week 6 | ||
Closure | Plan for further work | |
Relapse prevention |