I-SLEPT for Sleep Issues

(I-SLEPT Trial)

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JA
Overseen ByJennifer A Moye, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans improve sleep and engage in meaningful activities after discharge from a rehabilitation center. The study introduces a four-week program called I-SLEPT, which provides weekly telehealth sessions to promote better sleep habits and activity engagement. Veterans recently discharged from a VA Boston rehabilitation center who face challenges with sleep and daily activities might be a good fit. The trial focuses on stabilizing sleep and enhancing life engagement during a crucial recovery period. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

What prior data suggests that the I-SLEPT intervention is safe for Veterans?

Research has shown that the I-SLEPT program, designed to improve sleep and daily activities, is generally well-received. As the trial is just beginning, detailed information on side effects is limited, but any major safety concerns would likely have emerged by now.

The I-SLEPT treatment consists of a 4-week online program led by a licensed psychologist. The sessions help participants develop better sleep habits and engage more in meaningful activities. This method does not involve medication, which often results in fewer side effects.

While specific safety information for I-SLEPT is not yet available, the program's focus on education and behavior typically indicates a low risk of side effects. Participants can generally expect it to be safe, but discussing any potential risks with the healthcare team conducting the trial is always important.12345

Why are researchers excited about this trial?

I-SLEPT is unique because it focuses on improving sleep issues through a telehealth approach, which is not common in current treatments. Unlike standard medications or in-person therapy sessions, I-SLEPT delivers a 4-week intervention via video sessions, making it more accessible for veterans. It combines sleep education, habit building, and engagement in meaningful activities, which could lead to more sustainable improvements in sleep health. Researchers are excited about this treatment because it offers a flexible, comprehensive alternative that could be more convenient and effective for individuals struggling with sleep problems.

What evidence suggests that the I-SLEPT intervention is effective for sleep issues?

Research has shown that insufficient sleep can lead to serious health problems like high blood pressure and diabetes. Studies also find that poor sleep increases the risk of mental health issues, such as depression and anxiety. The I-SLEPT program, which participants in this trial will complete, aims to improve sleep and encourage activity, potentially lowering these risks. Early results suggest that better sleep can boost mood, decision-making, and learning. By focusing on sleep health and meaningful activities, I-SLEPT may help Veterans recover and improve their overall well-being.26789

Who Is on the Research Team?

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Julia T Boyle, PsyD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for veterans who are recovering from injuries and undergoing rehabilitation. It's designed to help them improve their sleep and daily life engagement after they leave the rehab facility. Specific eligibility criteria have not been provided, so it's best to contact the study organizers for details.

Inclusion Criteria

My mental status score is 8 or higher.
I am mentally capable of making my own decisions.
I was admitted to and discharged from VA Boston's subacute rehab.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Veterans complete I-SLEPT, a 4-week telehealth intervention focusing on sleep health and life engagement

4 weeks
4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • I-SLEPT

Trial Overview

The I-SLEPT program is being tested in this trial. It aims to stabilize sleep patterns and enhance participation in meaningful activities among veterans transitioning from rehabilitation back into their home environment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: I-SLEPTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

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