Clinical trial NCT04191720: Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Avoidant/Restrictive Food Intake Disorder
Anxiety
Keywords: anorexia nervosa
weighted blankets
occupational therapy
anxiety
deep pressure stimulation
randomized control trial
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety reduction
timeFrame: BAI measured during OT evaluation and through study completion, an average of 1 year
measure: Anxiety reduction
timeFrame: SUDS are measured during OT evaluation and through study completion, an average of 3 weeks
Secondary outcomes:
measure: Times weighted blankets are used
timeFrame: Behaviors will be documented every 2 hours over the course of treatment, through study completion, an average of 3 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: Denver Health Hospital and Authority
name: Rachel Ohene, MOT
role: PRINCIPAL_INVESTIGATOR
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