Cognitive Behavioural Therapy for Insomnia on Sleep in Rheumatoid Arthritis.

NCT03766100 | Completed

• 1 other identifier: H-18016081
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease that attacks peripheral joints and posterior tissues. More than half of patients with RA also have insomnia, which can modify pain, fatigue, quality of life and comorbidities. Traditional treatment of insomnia is often based on pharmacological drugs, however cognitive behavioural therapy for insomnia (CBT-i) have shown effect in insomnia with less side effects. It remains to determine whether CBT-i can be effective in patients with RA. The primary objective of this Sleep-RA trial is to assess the efficacy of CBT-i on sleep efficiency in patients with RA at week seven. Key secondary objectives are to estimate the clinical efficacy of CBT-i on wake after sleep onset, total sleep time, sleep onset latency, insomnia, sleep quality, fatigue, RA impact of disease and depressive symptoms at week 26. Methods \& Analysis: Sleep-RA will be carried out as a randomised controlled trial (RCT) with randomised assignment and two-group parallel design. Patients with RA and insomnia are randomly allocated 1:1 to the intervention group or the control group. The intervention group will once a week for six weeks receive group-based CBT-i, a multi-component intervention of; sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation. The control group will continue treatment as usual (insomnia will remain untreated). Follow-up assessments will be carried out seven and 26 weeks after baseline. The primary outcome is sleep efficiency measured with polysomnography at week seven. Key secondary outcomes are: wake after sleep onset, total sleep time, sleep onset latency, insomnia, sleep quality, fatigue, RA impact of disease and depressive symptoms from baseline to week 26. Polysomnography, actigraphy and Disease Activity Score 28-Joint Count C reactive protein will be assessed by medical staff blinded to group allocation. The project manager will assist the participants with questionnaires and conduct the intervention of CBT-i and will therefore not be blinded to group allocation. With a sample size of 60 patients the trial will have more than 85 % power to detect a mean difference between groups of 6 % points in the primary outcome of sleep efficiency measured at week seven and a reasonable statistical power to explore the clinical efficacy according to the eight key secondary outcome measures at week 26. Ethics and dissemination: Ethics approval has been obtained from The Committee on Health Research Ethics. We plan to submit a manuscript with the content of this protocol, and at least one scientific manuscript on the results of the primary and key secondary outcomes to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital grand rounds.

Conditions

Rheumatoid Arthritis; Insomnia

Keywords

Rheumatoid Arthritis; Insomnia; Sleep; Cognitive Behavioural Therapy for Insomnia; CBT-I; Non-pharmacological treatment; Polysomnography; Actigraphy; Patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• Polysomnography (PSG): Sleep efficiency.

  PSG is a multi-parametric test that is used in the study of sleep and as a diagnostic tool in sleep medicine. PSG is a comprehensive recording of the biophysiological changes that occur in the human body when the person is asleep. In Sleep-RA, 17 electrodes are attached to each participant, monitoring: electroencephalogram (EEG), eye movements electro-oculogram (EOG), electromyogram muscle activity or skeletal muscle activation (EMG), heart rhythm (ECG), respiratory airflow, respiratory effort and peripheral pulse oximetry.

  Assessed at week 7.

Secondary Outcomes (8)

• Polysomnography (PSG): Wake after sleep onset.

  Assessed at week 26.

• Polysomnography (PSG): Total sleep time.

  Assessed at week 26.

• Polysomnography (PSG): Sleep onset latency.

  Assessed at week 26.

• Insomnia Severity Index (ISI): Insomnia.

  Assessed at week 26.

• Pittsburgh Sleep Quality Index (PSQI): Sleep quality.

  Assessed at week 26.

Other Outcomes (45)

• Actigraphy: Sleep efficiency.

  Assessed at week 26.

• Actigraphy: Wake after sleep onset.

  Assessed at week 26.

• Actigraphy: Total sleep time.

  Assessed at week 26.

Study Arms (2)

Intervention group

EXPERIMENTAL

Cognitive Behavioural Therapy for Insomnia (CBT-i).

Behavioral: Cognitive behavioural therapy (CBT-i)

Control group

NO INTERVENTION

Insomnia is untreated.

Interventions

Cognitive behavioural therapy (CBT-i) BEHAVIORAL

CBT-i aims to alter behaviours that sustain or add to insomnia and correct cognitions that drive these behaviours. The behavioural components of CBT-i are stimulus control (SC) and Sleep Restriction Therapy (SRT). SC works through the extinction of a conditioned arousal that emerges when bed and bedroom have become associated with wakefulness. With SRT time in bed is reduced to build up sleep pressure. When wakefulness is decreased, time in bed is gradually increased until optimal sleep is attained. With the cognitive component, insomnia is treated by identifying and changing unhelpful or inaccurate thinking regarding sleep and distressing emotional responses to insomnia. The last component of CBT-i aims to reduce hyperarousal with relaxation techniques, scheduled worry time, creating a time to unwind, and employing cognitive therapy strategies.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with RA according to American College of Rheumatology/European League Against Rheumatism criteria 2010
• years of age or older
• Patients with low-to-moderate disease activity (DAS28-CRP ≤ 5.1)
• Sleep score ≥ 2 (DANBIO)
• Insomnia severity Index (ISI) ≥ 11
• Unchanged medical treatment with anti-rheumatics \> 3 months
• No indication for change of medical treatment with anti-rheumatic drugs the next three months
• Understand and read Danish.

You may not qualify if:

• Glucocorticoid administration (i.m., i.a., i.v.) \< four weeks
• Oral glucocorticoid administration \> 5 mg/day
• Change in oral glucocorticoid dose \< three month
• Prior or current contact with rheumatic sleep outpatient clinic
• Night work during the intervention
• Pregnant or breastfeeding
• Current alcohol or drug use disorder
• Patient related circumstances (physical or mental) that impede the ability to give informed consent or adhere to the trial programme.

Sponsors & Collaborators

• Bente Appel Esbensen: lead
• University of Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator
• Danish Cancer Society: collaborator
• Parker Research Institute: collaborator

Study Sites (1)

Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases

Glostrup Municipality, 2600, Denmark

Location

Related Publications (7)

• Abad VC, Sarinas PS, Guilleminault C. Sleep and rheumatologic disorders. Sleep Med Rev. 2008 Jun;12(3):211-28. doi: 10.1016/j.smrv.2007.09.001.

  PMID: 18486034 BACKGROUND

• Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018 Oct 2;320(13):1360-1372. doi: 10.1001/jama.2018.13103.

  PMID: 30285183 BACKGROUND

• Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001 Apr 11;285(14):1856-64. doi: 10.1001/jama.285.14.1856.

  PMID: 11308399 BACKGROUND

• Davidson JR, Dawson S, Krsmanovic A. Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting. Behav Sleep Med. 2019 Mar-Apr;17(2):191-201. doi: 10.1080/15402002.2017.1318753. Epub 2017 May 2.

  PMID: 28463015 BACKGROUND

• Smith MT, Finan PH, Buenaver LF, Robinson M, Haque U, Quain A, McInrue E, Han D, Leoutsakis J, Haythornthwaite JA. Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. Arthritis Rheumatol. 2015 May;67(5):1221-33. doi: 10.1002/art.39048.

  PMID: 25623343 BACKGROUND

• Latocha KM, Loppenthin KB, Ostergaard M, Jennum PJ, Hetland ML, Rogind H, Lundbak T, Midtgaard J, Christensen R, Esbensen BA. The effect of group-based cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: a randomized controlled trial. Rheumatology (Oxford). 2023 Mar 1;62(3):1097-1107. doi: 10.1093/rheumatology/keac448.

  PMID: 35951745 DERIVED

• Latocha KM, Loppenthin KB, Ostergaard M, Jennum PJ, Christensen R, Hetland M, Rogind H, Lundbak T, Midtgaard J, Esbensen BA. Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial. Trials. 2020 May 29;21(1):440. doi: 10.1186/s13063-020-04282-6.

  PMID: 32471477 DERIVED

Related Links

• Copenhagen Center for Arthritis Research (COPECARE)

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bente Appel Esbensen

  Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Application of PSG equipment prior to monitoring sleep efficiency and subsequent analysis of results will be conducted by neurophysiology assistants at the Danish Center for Sleep Medicine (DCSM) blinded to participants' allocation. Examination of participants' joints related to the secondary outcome of disease activity will be conducted by a project nurse specialized in rheumatology blinded to participants' allocation. Blood samples related to RA and disease activity will be taken and analysed by a medical laboratory technologist blinded to participants' allocation. Patient Reported Outcome Measures (PROMs) will be collected via questionnaires on tablets handed out by the project manager, who will also conduct the intervention of CBT-I, and therefore not able to be blinded to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher Manager, Associate professor

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 6, 2018
• Study Start: December 17, 2018
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

DK (1)