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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anorexia Nervosa, Avoidant/Restrictive Food Intake Disorder, Anxiety

Intervention / Treatment
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* Other: Weighted blanket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group, or usual care group, will receive occupational therapy standard of care. Occupational therapy standard of care provide training, education, and therapeutic activities including relaxation strategies. These coping mechanisms are aimed at reducing the impact of anxiety on a patient's performance and participation in necessary and meaningful activities of daily living, refeeding and medical stabilization. Specifically, these interventions will include diaphragmatic and yogic breathing exercises, mindfulness-based cognitive therapy (MBCT) education and exercises, therapeutic restorative yoga activities, occupational therapy group participation, aromatherapy, identifying and promoting engagement in meaningful leisure activities, client-centered sensory diets to provide patients with consistent preferred sensory experiences, and individualized checklists and schedules to grade the self-initiation of effective coping strategies. | |
| Experimental: Weighted blanket group<br>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. | Other: Weighted blanket<br>* Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety reduction | Beck Anxiety Inventory (BAI) | BAI measured during OT evaluation and through study completion, an average of 1 year | 
| Anxiety reduction | Subjective Units of Distress Scale (SUDS) | SUDS are measured during OT evaluation and through study completion, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexia nervosa, weighted blankets, occupational therapy, anxiety, deep pressure stimulation, randomized control trial