The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial

Abstract

Background: Depression 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. Methods: This 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. Discussion: This 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.

Insomnia and Depression - Bidirectional Cause and Effect: A Literature Review

“…Whether insomnia is part of depression or is something completely separate is still very difficult to trace. 18 Depression is one of the most common mental disorders and can vary from mild symptoms to severe symptoms. Insomnia is said to increase the risk of developing depression through several mechanisms.…”

“…(CBT) 15. CBT can be in the form of sleep restriction, stimulus control, cognitive therapy, sleep hygiene, and relaxation training18 It should be noted that some drugs can cause118 disturbances in sleep patterns. For example, desipramine and protriptyline reduce sleep time and increase wake time, clomipramine, amitriptyline, doxepin can induce sleep, tricyclic antidepressants can cause blockade of histamine H1, alpha1 adrenergic and muscarinic cholinergic receptors, and suppression of the REM cycle and may lead to daytime sleepiness.…”