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

Not Applicable

Completed

• Conditions: Avoidant/Restrictive Food Intake Disorder; Anxiety; Anorexia Nervosa
• Interventions: Other: Weighted blanket

• Registration Number: NCT04191720
• Lead Sponsor: Denver Health and Hospital Authority

Brief 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.

Study Timeline

• Study Start: 2018-11-16
• Primary Completion: 2019-03-19
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-05
• Last Update Submitted: 2019-12-05
• Study First Posted: 2019-12-10
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weighted blanket group	Weighted blanket	In the weighted blanket intervention group, patients will receive usual occupational therapy care in addition to a weighted blanket. The patient will be given an appropriately weighted blanket, within 1 lb +/- of 10% of body weight as measured on day of admission. Further, the occupational therapy will provide education to the patient on the use of the weighted blanket. Patients will be free to use the weighted blanket at their discretion, however, during meals, over the shoulders or head, and during ambulation, weighted blanket use will not be permitted.

Primary Outcome Measures

Name	Time	Method
Anxiety reduction	SUDS are measured during OT evaluation and through study completion, an average of 3 weeks	Subjective Units of Distress Scale (SUDS)

Secondary Outcome Measures

Name	Time	Method
Times weighted blankets are used	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

Trial Locations

Locations (1)

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States