Abstract
BackgroundDepression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design.MethodsThis study is a multicentre, randomized crossover trial with planned inclusion of 45 patients. The randomization procedure is permuted-block randomization with varying block sizes. Patients are allocated into either a sequence “AB” or “BA” each lasting 4 weeks (28 nights). Patients randomized to the “AB” sequence receive treatment A (Protac Ball Blanket™) in the first 2 weeks and switch to treatment B (treatment as usual) in the second period, whereas patients who are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period. The participants will serve as their own control in this design. The primary outcome is changes in total sleep time. Secondary outcome measures are changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics. Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia will be measured. A paired, two-sided t test to compare the means of the differences in the outcomes will be performed.DiscussionThis clinical trial will assess the effect of PBB on depression-related insomnia. The outcomes are of high interest as the PBB is a potential non-pharmacological supplement to medical treatment of patients with insomnia due to depression.Trial registrationClinicalTrials.gov Identifier: NCT03730974. Registered on 5 November 2018.
Highlights
Depression affects approx. 4% of the global population and is often accompanied by insomnia
Insomnia occurs in the majority of patients with depression [2] and is characterized as problems with initiating sleep, several wake ups, early morning awakening, reduced total sleep time, and daytime dysfunction [3,4,5], all causing poor sleep quality
Possible reasons for insomnia in depression are anxiety, impaired stress regulation, substance abuse, poor sleep hygiene, or ruminations [4, 10]. In both inpatient and outpatient psychiatry, medicine is often used to treat insomnia, but pharmacological treatment has side effects and, importantly, in case of benzodiazepines, there is a risk of drug tolerance and addiction [11] as well as somnolence during day-time
Summary
Depression affects approx. 4% of the global population and is often accompanied by insomnia. The Protac Ball BlanketTM (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design. Possible reasons for insomnia in depression are anxiety, impaired stress regulation, substance abuse, poor sleep hygiene, or ruminations [4, 10] In both inpatient and outpatient psychiatry, medicine is often used to treat insomnia, but pharmacological treatment has side effects and, importantly, in case of benzodiazepines, there is a risk of drug tolerance and addiction [11] as well as somnolence during day-time.
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