Sleep Better, Live Better Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorUniversity of Alabama at Birmingham
About this trial
The goal of this clinical trial is to determine the effects of a 12-week sleep behavioral program for adults ages 25-65 with poor sleep and elevated cardiometabolic risk. The main questions it aims to answer are: To evaluate the feasibility of recruitment, enrollment, retention, and data collection; program fidelity; and participant engagement with coaching sessions, text messages, and weekly check-ins; and to assess preliminary pre-post program changes in participant self-reported sleep, sleep self-efficacy, action and coping constructs, and Brain Care Score. Participants will: Complete seven structured sleep coaching sessions by telephone; complete a brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ages 25-65;
Self-reported sleep duration <7 hours per night;
Elevated cardiometabolic risk, i.e., presence of one or more of the following - hypertension, obesity, hyperlipidemia, diabetes;
Sleep is a behavioral target that individual wants to improve;
Disqualifiers
Exceeds eligibility screening thresholds: ISI-7 score ≥22, STOP-BANG score ≥5, ESS score ≥11;
Unable to complete study procedures in English;
No access to mobile phone with text messaging features;
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Sleep Better, Live Better
BehavioralSleep program designed to target modifiable behavioral processes underlying sleep health, including action planning, coping planning, and self-efficacy, to support behavioral change. Participants select one or two sleep behavioral targets to improve and then over 12 weeks, complete seven structured sleep coaching sessions by telephone, complete brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Sleep behavioral programExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Sleep Self-Efficacy From Baseline to 12 Weeks
Sleep self-efficacy will be assessed using the 9-item Sleep Self-Efficacy Scale. Each item is rated on a 5-point scale from 1 (not confident at all) to 5 (very confident) and summed to produce a total score ranging from 9 - 45. Higher scores indicate greater confidence in performing sleep-related behaviors. (Scoring: sum the 9 items: possible total = 9 - 45, higher = greater sleep self-efficacy.) The outcome will be the change in Sleep Self-Efficacy Scale score from baseline to 12 weeks.
Time frame
From baseline to 12 weeks.Secondary outcomes
1
Change in Sleep Action Planning From Baseline to 12 Weeks
Sleep action planning will be assessed using the 5-item Sleep Action Planning Scale. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The mean of the five items is calculated, producing a score ranging from 1 to 5, with higher scores indicating stronger action planning for healthy sleep behaviors. The outcome will be the change in mean score from baseline to 12 weeks.
Time frame
From baseline to 12 weeks2
Change in Sleep Coping Planning From Baseline to 12 Weeks
Sleep coping planning will be assessed using the 5-item Sleep Coping Planning Scale. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The mean of the five items is calculated, producing a score ranging from 1 to 5, with higher scores indicating stronger planning for managing barriers to healthy sleep. The outcome will be the change in mean score from baseline to 12 weeks.
Time frame
From baseline to 12 weeks.3
Change in PROMIS Sleep Disturbance Score From Baseline to 12 Weeks
Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 8a, an 8-item self-report measure assessing sleep quality and sleep-related difficulties during the past 7 days. Item responses are summed and converted to standardized PROMIS T-scores, with higher scores indicating greater sleep disturbance. The outcome will be the change in PROMIS Sleep Disturbance score from baseline to 12 weeks.
Time frame
From baseline to 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov