Sleep Optimization to Aid in Recovery Digital Program

NCT07518368 | Not Yet Recruiting

• 1 other identifier: UNLV-2025-634
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Health; Binge Eating; Disordered Eating; Sleep Disturbances

Keywords

Eating disorders; Disordered eating; Binge eating; Sleep health; Sleep disturbances; waitlist; eating disorder treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Acceptability of Intervention Measure (AIM)

  Within 24 hours post-intervention

• Intervention Appropriateness Measure (IAM)

  Within 24 hours post-intervention

• Feasibility of Intervention Measure (FIM)

  Within 24 hours post-intervention

• System Usability Scale (SUS)

  Within 24 hours post-intervention

• Sleep Hygiene Index

  Baseline and one-month follow-up

Other Outcomes (6)

• Sleep Health (RU-SATED)

  Baseline and one-month follow-up

• Eating Disorder-15

  Baseline and one-month follow-up

• Generalized Anxiety Disorder-7

  Baseline and one-month follow-up

Study Arms (2)

SOAR Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

SOAR BEHAVIORAL

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.

SOAR Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

MeSH Terms

Conditions

Bulimia; Parasomnias; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kara Christensen Pacella, Ph.D.

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosha Feizi Lighvan, B.A.

CONTACT

702-895-2099; crest@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available upon reasonable request after the completion of the trial.
• 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.