Sleep Optimization to Aid in Recovery Digital Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nevada, Las Vegas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
SOAR
BehavioralSOAR 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.
Treatment groups
154 Participants
are divided into 2 treatment groupsGroup A: SOAR InterventionExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
PROMIS Sleep Disturbance
Scores range from 8 to 40 with higher scores indicating greater sleep disturbance.
Time frame
Baseline and one-month follow-up2
PROMIS Sleep Impairment
Scores range from 8 to 40 with higher scores indicating greater impairment from sleep problems.
Time frame
Baseline and one-month follow-upSecondary outcomes
1
Acceptability of Intervention Measure (AIM)
Scores range from 1 to 5 with higher scores indicating greater acceptability of the intervention.
Time frame
Within 24 hours post-intervention2
Intervention Appropriateness Measure (IAM)
Scores range from 1 to 5 with higher scores indicating greater appropriateness of the intervention.
Time frame
Within 24 hours post-intervention3
Feasibility of Intervention Measure (FIM)
Scores range from 1 to 5 with higher scores indicating greater feasibility of the intervention.
Time frame
Within 24 hours post-intervention4
System Usability Scale (SUS)
Scores range from 0 to 100 with higher scores indicating greater usability of the intervention.
Time frame
Within 24 hours post-interventionOther outcomes
1
Sleep Health (RU-SATED)
Scores range from 0 to 14 with higher scores indicating better sleep health
Time frame
Baseline and one-month follow-up2
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.
Time frame
Baseline and one-month follow-up3
Generalized Anxiety Disorder-7
Scores range from 0 to 21 with higher scores indicate greater generalized anxiety disorder pathology.
Time frame
Baseline and one-month follow-up4
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.
Time frame
Baseline and one-month follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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