Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review


  1. Discontinuation of antidepressants

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. HVAD ER DEPRESSION? - Bliv klogere på årsager, behandling og forebyggelse

    Publikation: Bog/antologi/afhandling/rapportBogFormidling

  3. National Klinisk Retningslinje for Vanskeligt Behandlelig depression

    Publikation: Bidrag til bog/antologi/rapportBidrag til rapportFormidling

  4. Low frequency rTMS, inhibits the antidepressive effect of ECT. A pilot study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Stilheden før stormen - om psykiatrisk sygdom i coronaens tid

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Sanne Toft Kristiansen
  • Poul Videbech
  • Merete Bender Bjerrum
  • Erik Roj Larsen
Vis graf over relationer

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: Identifier: NCT03730974 . Registered on 5 November 2018.

Udgave nummer1
Sider (fra-til)720
StatusUdgivet - 17 aug. 2020

ID: 60733223