NCT07317336 · VA Office of Research and Development
I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
(I-SLEPT)
What this study is about
Sleep is essential to functional recovery in rehabilitation settings; however, sleep is likely to be disrupted during rehabilitation admissions. Adverse effects of these disruptions do not subside after discharge, leading to additional consequences such as poor physical function.
View original scientific description
Sleep is essential to functional recovery in rehabilitation settings; however, sleep is likely to be disrupted during rehabilitation admissions. Adverse effects of these disruptions do not subside after discharge, leading to additional consequences such as poor physical function. Veterans are particularly impacted by poor sleep and medical complexities that can lead to injuries requiring rehabilitative care to support their recovery. This may be more apparent in older Veteran populations. After discharge, Veterans must re-acclimate to their home environment while facing potential changes in their sleep, life engagement (e.g., pleasant activities, physical function), and health. This study will create the I-SLEPT (Integrated Sleep and Life Engagement Program for Transitions) intervention, which will support Veterans by stabilizing their sleep and by maximizing participation in meaningful activities during a critical and vulnerable period of recovery.
Interventions
BEHAVIORAL
I-SLEPT
Veterans in Aim 3 will complete I-SLEPT, a 4-week telehealth intervention, delivered by a licensed clinical psychologist. Sessions will take place once a week for 60 minutes primarily using VA Video Connect. Sessions will include components focused on 1) promoting sleep health through education and habits and 2) increase engagement in meaningful activities.
Primary outcome measures
RuSATED
Time frame: Baseline, Endpoint (30 day), 3 Month
A brief 6-item measure encompassing the dimensions of sleep health: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Scores range from 0 to 12 with higher total scores suggesting better sleep health. Items are rated on a 3-point scale from 0 to 2 (with 0 = Rarely/Never; 1 = Sometimes; and 2 = Usually/Always).
What Matters Most (WMM) Tool
Time frame: Baseline, Endpoint (30 day), 3 Month
A one-page brief tool presenting 3 domains (Staying Independent, Enjoying Life, and Connecting), each containing a list of 9 items with the option of adding a 10th item of their own. Veterans will be asked to identify up to 3 items within each domain that matters most to them. After up to 9 items total have been identified, Veterans will be asked to "pick the most important thing" and describe what this would look like for them "day to day or week to week." Veterans will be encouraged to pick up to 3 things that matter most above all. Finally, Veterans are asked to rate how well they are achieving their life engagement goals and what matters most to them, employing a 5-point Likert-style goal attainment scale (+2 = much better than expected; +1 = a little better than expected; 0 = as expected; -1 = a little worse than expected; -2 = much worse than expected). A score of 0-2 indicate satisfactory goal attainment in the area of life engagement.
Acceptability of Intervention Measure (AIM)
Time frame: Endpoint (30 day)
A 4-item measure that assess acceptability, defined here as the perception that I-SLEPT is acceptable, palatable, or satisfactory. Items are scored as follows: 1 - completely disagree; 2 - disagree; 3 - neither agree nor disagree; 4 - agree; 5 - completely agree. Total scores are from 4 to 20 with higher scores indicating better acceptability of the intervention.
Feasibility of Intervention Measure (FIM)
Time frame: Endpoint (30 day)
A 4-item measure that assesses feasibility defined here as the extent to which the session material can be successfully used - defined as from the Veteran's perspective of applying what is learned after the session. Items are scored as follows: 1 - completely disagree; 2 - disagree; 3 - neither agree nor disagree; 4 - agree; 5 - completely agree. Total scores are from 4 to 20 with higher scores indicating better feasibility of the intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Admitted to and discharged from VA Boston Community Living Center subacute rehabilitation
- English-speaking
- Discharged to a home setting
- Has capacity and does not have severe cognitive impairment
- Obtains a score \>= 8 on the Brief Interview for Mental Status (BIMS)
- Endorses at least 2 items as "Rarely/Never" or "Sometimes" on the RuSATED measure AND/OR endorses they are achieving their goals at a "much worse" or "a little worse" level on the What Matters Most Tool.
Exclusion criteria
- Discharged from Long-Term Care, Hospice and Palliative Care, or Spinal Cord Injury bed specialty
- Moderate to severe dementia diagnosis, delirium, or active psychosis
- Healthcare proxy is activated in electronic health record
- A diagnosis of a disorder of hypersomnolence, non-REM parasomnia, or Nightmare Disorder as indicated in electronic health record
- High acute risk for suicide
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations