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

NCT04191720 | Completed

• 1 other identifier: 18-0596
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Avoidant/Restrictive Food Intake Disorder; Anxiety

Keywords

anorexia nervosa; weighted blankets; occupational therapy; anxiety; deep pressure stimulation; randomized control trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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

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

Interventions

Weighted blanket OTHER

Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety

Weighted blanket group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing mothers

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related Publications (22)

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  BACKGROUND

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MeSH Terms

Conditions

Anorexia Nervosa; Avoidant Restrictive Food Intake Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Rachel Ohene, MOT

  Denver Health Hospital and Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 10, 2019
• Study Start: November 16, 2018
• Primary Completion: March 19, 2019
• Study Completion: November 30, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)