An interventional study of Weighted blanket in Anorexia Nervosa, Avoidant/Restrictive Food Intake Disorder and Anxiety, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Supportive care
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.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 24 is below the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
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Exclusion Criteria:
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.
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
Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety
Anxiety reduction
Beck Anxiety Inventory (BAI)
Time frame: BAI measured during OT evaluation and through study completion, an average of 1 year
Anxiety reduction
Subjective Units of Distress Scale (SUDS)
Time frame: SUDS are measured during OT evaluation and through study completion, an average of 3 weeks
Times weighted blankets are used
Ratio of times weighted blankets were used vs when not in use
Time frame: Behaviors will be documented every 2 hours over the course of treatment, through study completion, an average of 3 weeks
Plan to share: No — If we decide to share the data, we would ask researchers to reach out to the PI
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Denver Health and Hospital Authority