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

NCT ID: NCT07317336

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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This project will create I-SLEPT (Integrated Sleep and Life Engagement Program for Transitions), a novel intervention to enhance sleep health and life engagement during the transition period following discharge from VA subacute rehabilitation. The development of I-SLEPT will be informed by both Veterans and experts. Including the Veteran perspective is essential to reflect Veterans' choice, ensure access to timely care, and prioritize effective care solutions to improve Veterans' health and well-being. Veterans are more likely to report poor sleep and medical complexities than non-Veterans which may further complicate their readjustment to their home environment after discharge. The proposed study is a single arm clinical trial. Veterans aged 50+ discharged home from the subacute rehabilitation units at VA Boston's Community Living Center will be recruited to complete surveys and interviews informing I-SLEPT creation (Aim 1; N=20), complete a preliminary trial (Aim 2; N=5) or complete a single-arm Proof-of-Concept trial (Aim 3; N=40). Veterans participating in Aims 2 or 3 will complete assessments of sleep health and life engagement, as well as acceptability measures. Results may also inform future work adapting this intervention to other transitional phases (e.g., discharge from acute hospitalization), support Veterans across the lifespan, and support intervention implementation by staff from multiple disciplines and specialties, including nursing, social work, physical therapy, occupational therapy, and Veteran peer specialists.

Conditions

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Sleep Participation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

I-SLEPT

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia T Boyle, PsyD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Julia T Boyle, PsyD

Role: CONTACT

(617) 963-6391

Jennifer A Moye, PhD

Role: CONTACT

(774) 826-3721

Facility Contacts

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Julia T Boyle, PsyD

Role: primary

617-963-6391

Jennifer A Moye, PhD

Role: backup

(774) 826-3721

Other Identifiers

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1IK2RD000347-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RRD9-010-25M

Identifier Type: -

Identifier Source: org_study_id

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