TIMELAPSE study—efficacy of low-dose amitriptyline versus cognitive behavioral therapy for chronic insomnia in patients with medical comorbidity: study protocol of a randomized controlled multicenter non-inferiority trial

Trials

Annemieke van Straten¹  Hans Knoop²  Annemarie M. J. Braamse²  Irene Pot³  Nynke L. Rauwerda⁴  Marian E. Rikkert⁵  Anouk Zondervan⁶  H. Myrthe Boss⁷  Thom P. J. Timmerhuis⁸ 

[1] Department of Clinical Psychology & Amsterdam Public Health Research Institute, VU University, Amsterdam, The Netherlands;Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands;Department of Medical Psychology, Hospital Gelderse Vallei, Ede, The Netherlands;Department of Medical Psychology, Hospital Gelderse Vallei, Ede, The Netherlands;Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands;Department of Medical Psychology, Hospital Rivierenland, Tiel, The Netherlands;Department of Medical Psychology, Zaans Medical Center, Zaandam, The Netherlands;Department of Neurology, Hospital Gelderse Vallei, Ede, The Netherlands;Department of Neurology, Jeroen Bosch Ziekenhuis, ‘s-Hertogenbosch, the Netherlands;

关键词: Insomnia;    Medical comorbidity;    Amitriptyline;    Cognitive behavioral therapy;    CBT-I;    Fatigue;    Pain;    Treatment preference;    Non-inferiority;   

DOI  :  10.1186/s13063-021-05868-4

来源: Springer

【 摘 要 】

BackgroundInsomnia 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/designThis 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.DiscussionIrrespective 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 registrationDutch Trial Register NTR NL7971. Registered on 18 August 2019

【 授权许可】

CC BY