Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial

Abstract

BackgroundA significant proportion of patients with chronic tinnitus report clinical levels of sleep disturbance (insomnia). Despite the significant health and functioning implications of this, no rigorous trials have investigated treatments that target tinnitus-related insomnia. This is the first randomised controlled trial evaluating Cognitive Behavioural Therapy for insomnia (CBTi) in tinnitus compared with other psychological treatments.Methods/designThe study will test the efficacy of group CBTi as a treatment for tinnitus-related insomnia in a single-centre randomised controlled trial. Participants will be 102 patients with chronic, clinically significant tinnitus and insomnia in the absence of organic sleep disorders. Participants will be randomised to one of three intervention arms: six sessions of CBTi or six sessions of sleep support group or two sessions of audiologically based care. The primary outcomes will be changes in sleep as measured on the Insomnia Severity Index and key outcomes on a 2-week sleep diary (sleep efficiency and total sleep time). Outcomes will be collected 3, 10, 14 and 34 weeks post-randomisation. Secondary measures include sleep quality, sleep beliefs, tinnitus severity, psychological distress and quality of life. A sub-sample of participants will provide two weeks of actigraphy data at the same time points. Data on satisfaction and treatment experience will be collected at 10 and 34 weeks post-randomisation from all participants.DiscussionFindings from the study will be submitted to a peer-reviewed journal. It is anticipated that findings may inform future clinical practice in the treatment of tinnitus-related insomnia.Trial registrationClinicalTrials.gov, NCT03386123. Retrospectively registered on 29 December 2017.

Prevalence and Related Factors of Insomnia Among Chinese Medical Staff in the Middle and Late Stage of COVID-19

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“…Second, during the COVID-19 epidemic, medical staff with physical diseases may worry about infection, resulting in more serious symptoms of anxiety and insomnia. Moreover, negative thoughts about threatening symptoms may lead to persistent insomnia ( 36 ).…”

The effect of acceptance and commitment therapy on insomnia and sleep quality: A systematic review

“…CBT-I in the short term has the same effect as drug therapy on insomnia. Since the drug treatments pose long-term side effects in people with insomnia, the desire to treat with CBT has increased [14,15]. A meta-analysis study by Geiger-Brown et al (2015) found that sleep quality improves after the CBT-I treatment.…”

Insomnia, Anxiety and Depression in Adult Cochlear Implant Users With Tinnitus

“…There is robust evidence available suggesting that specific types of cognitive behavioral therapy (CBT) can be effective in treating tinnitus and insomnia (Cima et al 2012;Geiger-Brown et al 2015;Martinez-Devesa et al 2010; for a review see McKenna & Daniel 2006), as well as anxiety and depression disorders (Carpenter et al 2018;Twomey et al 2015). Current trials suggest that CBT is an effective intervention for the management of tinnitus-related insomnia (Andersson et al 2005;Beukes et al 2017;Jasper et al 2014;Marks et al 2019;Weise et al 2016). However, it is not clear whether CI users would be willing to undergo new therapies to treat their tinnitus-related sleep problems in addition to the therapies they may already receive to manage any adverse effects associated with their profound hearing loss.…”