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

Anxiety Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04191720
• Other study ID #: 18-0596
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anxiety
• Anxiety Disorders
• Avoidant/Restrictive Food Intake Disorder
• Body Weight

Intervention

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

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Nakai Y, Nin K, Noma S, Teramukai S, Wonderlich SA. Characteristics of Avoidant/Restrictive Food Intake Disorder in a Cohort of Adult Patients. Eur Eat Disord Rev. 2016 Nov;24(6):528-530. doi: 10.1002/erv.2476. Epub 2016 Sep 4. — View Citation

Nicely TA, Lane-Loney S, Masciulli E, Hollenbeak CS, Ornstein RM. Prevalence and characteristics of avoidant/restrictive food intake disorder in a cohort of young patients in day treatment for eating disorders. J Eat Disord. 2014 Aug 2;2(1):21. doi: 10.1186/s40337-014-0021-3. eCollection 2014. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety reduction	Beck Anxiety Inventory (BAI)	BAI measured during OT evaluation and through study completion, an average of 1 year
Primary	Anxiety reduction	Subjective Units of Distress Scale (SUDS)	SUDS are measured during OT evaluation and through study completion, an average of 3 weeks
Secondary	Times weighted blankets are used	Ratio of times weighted blankets were used vs when not in use	Behaviors will be documented every 2 hours over the course of treatment, through study completion, an average of 3 weeks