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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anorexia Nervosa
- Sponsor
- Denver Health and Hospital Authority
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Anxiety reduction
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Rachel Ohene
Occupational Therapist
Denver Health and Hospital Authority
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
Outcomes
Primary Outcomes
Anxiety reduction
Time Frame: SUDS are measured during OT evaluation and through study completion, an average of 3 weeks
Subjective Units of Distress Scale (SUDS)
Secondary Outcomes
- 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)