Background: While normal tinnitus is a short-term sensation of limited duration, in 10–15% of the general population it develops into a chronic condition. For 3–6% it seriously interferes with many aspects of life. Objective: The aim of this trial was to assess effectiveness of a trauma-focused approach, eye movement desensitization and reprocessing (EMDR), in reducing tinnitus distress. Methods: The sample consisted of 35 adults with high levels of chronic tinnitus distress from five general hospitals in the Netherlands. Participants served as their own controls. After pre-assessment (T1), participants waited for a period of 3 months, after which they were assessed again (T2) before they received six 90 min manualized EMDR treatment sessions in which tinnitus-related traumatic or stressful events were the focus of treatment. Standardized self-report measures, the Tinnitus Functional Index (TFI), Mini-Tinnitus Questionnaire (Mini-TQ), Symptom Checklist-90 (SCL-90) and the Self-Rating Inventory List for Post-traumatic Stress Disorder (SRIP), were completed again halfway through treatment (T3), post-treatment (T4) and at 3 months’ follow-up (T5). Results: Repeated measures analysis of variance revealed significant improvement after EMDR treatment on the primary outcome, TFI. Compared to the waiting-list condition, scores significantly decreased in EMDR treatment [t(34) = −4.25, p < .001, Cohen’s dz = .72]. Secondary outcomes, Mini-TQ and SCL-90, also decreased significantly. The treatment effects remained stable at 3 months’ follow-up. No adverse events or side effects were noted in this trial. Conclusions: This is the first study to suggest that EMDR is effective in reducing tinnitus distress. Randomized controlled trials are warranted.

Background Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low-dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial, we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I. Methods/design This study will test if treatment with low-dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12 weeks AM (starting with 10 mg per day, and if ineffective at 3 weeks, doubling this dose) or 12 weeks of CBT-I consisting of 6 weekly sessions and a follow-up session 6 weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12 weeks. Secondary outcomes include sleep quality (e.g., sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning), and symptoms (e.g., fatigue, pain, anxiety) at 12 weeks and 12 months post treatment and relapse of insomnia until 12 months after treatment. Discussion Irrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity. Trial registration Dutch Trial Register NTR NL7971. Registered on 18 August 2019

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Background Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I.Methods / design This study will test if treatment with low dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12 weeks AM (starting with 10 mg per day, and if ineffective at 3 weeks, doubling this dose) or 12 weeks of CBT-I consisting of 6 weekly sessions and a follow up session 6 weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12 weeks. Secondary outcomes include sleep quality (e.g. sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning) and symptoms (e.g. fatigue, pain, anxiety) at 12 weeks and 12 months post treatment and relapse of insomnia until 12 months after treatment. Discussion Irrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity. Trail registration Dutch Trial Register, NTR NL7971, 18 August 2019