I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions

NCT07317336 | Not Yet Recruiting

• 2 other identifiers: RRD9-010-25M1IK2RD000347-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Participation

Keywords

sleep; participation; rehabilitation; transitions of care; physical function

Outcome Measures

Primary Outcomes (4)

• RuSATED

  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).

  Baseline, Endpoint (30 day), 3 Month

• What Matters Most (WMM) Tool

  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.

  Baseline, Endpoint (30 day), 3 Month

• Acceptability of Intervention Measure (AIM)

  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.

  Endpoint (30 day)

• Feasibility of Intervention Measure (FIM)

  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.

  Endpoint (30 day)

Secondary Outcomes (1)

• Intervention Appropriateness Measure (IAM)

  Endpoint (30 day)

Study Arms (1)

I-SLEPT

EXPERIMENTAL

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.

Behavioral: I-SLEPT

Interventions

I-SLEPT BEHAVIORAL

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.

I-SLEPT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Study Officials

• Julia T Boyle, PsyD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia T Boyle, PsyD

CONTACT

(617) 963-6391; julia.boyle@va.gov

Jennifer A Moye, PhD

CONTACT

(774) 826-3721; Jennifer.Moye@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Assess for feasibility and clinically significant results of I-SLEPT in a proof-of-concept, single-arm trail in Veterans (Enrollment Target; N = 60) age 50 years and older who were recently discharged from VA Boston Subacute Rehabilitation to home. Targeting 40 completers.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)