Skip to main content
OpenTrials
Completed

NCT Number: NCT04191720

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anorexia Nervosa Anxiety Anxiety Disorders Avoidant Restrictive Food Intake Disorder Avoidant/Restrictive Food Intake Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically diagnosed with AN-R, AN-BP, or ARFID upon admission (per Diagnostic and Statistical Manual-V criteria)
  • Moderate/Major Anxiety per initial evaluation score using BAI
  • OT assessment

Exclusion criteria

  • Pregnant or nursing mothers

Treatment and study plan

Weighted Blanket

Other

Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety

Primary outcomes

  1. Anxiety reduction

    Time frame: BAI measured during OT evaluation and through study completion, an average of 1 year

    Beck Anxiety Inventory (BAI)

  2. Anxiety reduction

    Time frame: SUDS are measured during OT evaluation and through study completion, an average of 3 weeks

    Subjective Units of Distress Scale (SUDS)

Secondary outcomes

  1. Times weighted blankets are used

    Time frame: Behaviors will be documented every 2 hours over the course of treatment, through study completion, an average of 3 weeks

    Ratio of times weighted blankets were used vs when not in use

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.