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

Sanne Toft Kristiansen, Poul Videbech, Merete Bender Bjerrum, Erik Roj Larsen, Sanne Toft Kristiansen, Poul Videbech, Merete Bender Bjerrum, Erik Roj Larsen

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.

Trial registration: ClinicalTrials.gov Identifier: NCT03730974 . Registered on 5 November 2018.

Keywords: Actigraphy; Crossover studies; Depressive disorder; Insomnia; Outpatients; Weighted blankets.

Conflict of interest statement

This is an industry-supported trial. The company Protac A/S covers 50% of STK’s salary in collaboration with The Innovation Fund Denmark, who covers the remaining 50%. However, trial sponsors and funders have no role in the study design; the collection, management, analysis, and interpretation of data; the writing of the report; and the decision to submit the report for publication.

Figures

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Fig. 1
Participant timeline
Fig. 2
Fig. 2
Study schedule for enrolment, intervention, and assessments

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Source: PubMed

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