Anorexia Nervosa, Anxiety, Avoidant/Restrictive Food Intake Disorder
Conditions
Keywords
anorexia nervosa, weighted blankets, occupational therapy, anxiety, deep pressure stimulation, randomized control trial
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.
Interventions
OTHERWeighted blanket
Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety
Sponsors
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety reduction | BAI measured during OT evaluation and through study completion, an average of 1 year | Beck Anxiety Inventory (BAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Times weighted blankets are used | Behaviors will be documented every 2 hours over the course of treatment, through study completion, an average of 3 weeks | Ratio of times weighted blankets were used vs when not in use |
Countries
United States
Outcome results
None listed