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

Denver Health and Hospital Authority

Status: Completed

Conditions: Anorexia Nervosa; Anxiety; Avoidant/Restrictive Food Intake Disorder

Treatments: Other: Weighted blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT04191720

18-0596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Weighted blanket group

Experimental group

Description:

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.

Treatment:

Other: Weighted blanket