Sleep Optimization to Aid in Recovery Digital Program (SOARPilot)

The purpose of this pilot study is to evaluate the usability and feasibility of SOAR (Sleep Optimization to Aid Recovery), a brief and self-guided digital program designed to share evidence-based sleep hygiene information with individuals seeking treatment for an eating disorder. The SOAR program delivers well-established recommendations promoted by the National Sleep Foundation and other professional sleep health organizations. The purpose of this study is not to test a new treatment or intervention per se, but rather to examine how effectively this existing information can be delivered through a digital platform to people preparing for or engaged in eating disorder treatment. By providing these evidence-based strategies in a user-friendly and accessible format, SOAR aims to support healthy sleep habits that may enhance overall well-being and facilitate recovery.

The investigators will compare SOAR against a control condition, which would be no intervention (treatment-as-usual). Participants randomized to the control will receive access to SOAR after the follow-up period has ended, if they wish to use it.

Study Overview

• Status: Not yet recruiting
• Conditions: Binge Eating; Sleep Health; Sleep Disturbances; Disordered Eating
• Intervention / Treatment: Behavioral: SOAR

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosha Feizi Lighvan, B.A.; Phone Number: 702-895-2099; Email: crest@unlv.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older,
• Initiating treatment for an eating disorder (e.g., currently on a waitlist for eating disorder treatment, scheduled to start treatment, completed an intake, or started treatment within the past two weeks for an eating disorder),
• Able to access the internet

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOAR Intervention; The SOAR program is designed to help improve sleep health for people beginning eating disorder treatment. The packaging of the SOAR intervention (e.g., videos) and the targeting of these materials to an eating disorder treatment context represent the novel experimental contributions of this program.	Behavioral: SOAR; SOAR is administered using the REDCap platform. It consists of a series of videos about the science behind the link between eating disorders and sleep and best practices and tips for sleep health recommended by leading sleep health organizations. SOAR includes sleep hygiene information, videos on stimulus control (a best practices intervention for insomnia), and instructions for setting a regular sleep/wake time. At the end of the program, users will create a sleep action plan using the information they learned from SOAR.
No Intervention: Control Group; The current standard of care is no intervention. The no intervention condition thus is treatment-as-usual. Participants will receive the option to access the active intervention at the conclusion of their study participation. These participants will complete the baseline session and the follow-up survey only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Sleep Disturbance	Scores range from 8 to 40 with higher scores indicating greater sleep disturbance.	Baseline and one-month follow-up
PROMIS Sleep Impairment	Scores range from 8 to 40 with higher scores indicating greater impairment from sleep problems.	Baseline and one-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	Scores range from 1 to 5 with higher scores indicating greater acceptability of the intervention.	Within 24 hours post-intervention
Intervention Appropriateness Measure (IAM)	Scores range from 1 to 5 with higher scores indicating greater appropriateness of the intervention.	Within 24 hours post-intervention
Feasibility of Intervention Measure (FIM)	Scores range from 1 to 5 with higher scores indicating greater feasibility of the intervention.	Within 24 hours post-intervention
System Usability Scale (SUS)	Scores range from 0 to 100 with higher scores indicating greater usability of the intervention.	Within 24 hours post-intervention
Sleep Hygiene Index	Scores range from 13-65 with higher global scores indicative of more maladaptive sleep hygiene practices.	Baseline and one-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Health (RU-SATED)	Scores range from 0 to 14 with higher scores indicating better sleep health	Baseline and one-month follow-up
Eating Disorder-15	Scores for the two factors (Weight & Shape Concerns and Eating Concerns) and the total score are presented as an average score (between 0 to 6) with a higher score indicating more eating-disordered cognitions and behaviors.	Baseline and one-month follow-up
Generalized Anxiety Disorder-7	Scores range from 0 to 21 with higher scores indicate greater generalized anxiety disorder pathology.	Baseline and one-month follow-up
Patient Health Questionnaire-8	Scores range from 0 to 24 with higher scores indicating greater depressive pathology. The suicidality question from the PHQ-9 will not be administered.	Baseline and one-month follow-up
Self-Efficacy Scale	Scores range from 10 to 40 with higher scores indicating greater self-efficacy.	Baseline and one-month follow-up
Clinical Impairment Asssessment	Scores range from 0 to 48 with higher scores indicating greater impairment from eating disorder symptoms.	Baseline and one-month follow-up

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Investigators: Principal Investigator: Kara Christensen Pacella, Ph.D., University of Nevada, Las Vegas

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sleep disturbances; Eating disorders; Binge eating; eating disorder treatment; Disordered eating; waitlist; Sleep health
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Sleep Wake Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bulimia; Parasomnias; Feeding and Eating Disorders
• Other Study ID Numbers: UNLV-2025-634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial will be included; however, any personal information that could identify participants will be removed or recoded prior to sharing.
• IPD Sharing Time Frame: IPD will be available upon reasonable request after the completion of the trial.
• IPD Sharing Access Criteria: Researchers at public or private institutions may email the study team to request access to the IPD. A data dictionary of variable names will be publicly posted to the study's OSF page.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No