NCT04191720

Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol

A Randomized Control Trial to Assess the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa and Avoidant Restrictive Food Intake Disorder: a Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to conduct a randomized control trial (RCT) to assess the efficacy of weighted blankets (WB), on anxiety for patients with severe anorexia nervosa (AN) and avoidant restrictive food intake disorder (ARFID) in an inpatient medical setting. We hypothesize that using weighted blankets will reduce anxiety in these patient populations.

Detailed description

Anorexia nervosa (AN) has one of the highest mortality rates of any psychiatric disorder with anxiety being a common comorbidity. The standard of care for inpatient medical stabilization for patients diagnosed with AN is a multidisciplinary approach with emphasis on nutrition, psychotherapy, and medical management of complaints. Weighted blankets, an example of deep pressure stimulation, have been shown to reduce anxiety. However, not much is known about the effect of weighted blankets in the eating disorder population. Therefore, this randomized control trial (RCT) protocol outlines a study design for assessing the effect of weighted blankets on patients with AN. A two-arm RCT design will be implemented for this study. A convenience sample of 24 patients will be enrolled with 12 patients in the control and intervention groups based on inclusion criteria. The control group will receive Denver Health's standard of care for patients admitted to its well-known medical stabilization unit for patients with extreme form of eating disorders, while the intervention group will receive both the standard of care and a weighted blanket. A mixed-design ANOVA will be performed to explore differences in the Beck's Anxiety Inventory and Subjective Units of Distress Scale between the intervention and control groups.

Conditions

• Anorexia Nervosa
• Avoidant/Restrictive Food Intake Disorder
• Anxiety

Interventions

Type	Name	Description
OTHER	Weighted blanket	Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety

Timeline

• Start date: 2018-11-16
• Primary completion: 2019-03-19
• Completion: 2019-11-30
• First posted: 2019-12-10
• Last updated: 2019-12-10

Locations

1 site across 1 country: United States