NCT02871414

Brief Summary

The purpose of the project is to improve the sleep quality and sleep duration of post 9/11 veterans seeking college degrees. Preliminary research findings within CSU's New Start for Student Veterans program indicate veterans with service-related injuries report difficulties with sleep quality and duration. The REST program will recruit 24 college veterans and engage them in a seven-week multi component sleep improvement program using evidence-based educational and behavioral change supports that are considered best practice for improving sleep quality. The investigators' scientific objectives in this application are to establish the efficacy of a group-based sleep education and sleep-skills intervention to improve sleep quality and duration, and to advance understanding of relationships between participants' sleep-related knowledge and behaviors associated with improved sleep quality and duration in veterans with service-related injuries in college. The investigators will initially engage 8 participants to establish treatment fidelity and participant satisfaction of the 7-week group intervention. This will be followed by engaging 16 additional participants in the 7-week group intervention, 8 will be randomly placed as wait-list controls and then receive the intervention. The 7-week group intervention will take place within the CSU Occupational Therapy Department, and all assessments will be completed using a web-based survey.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

August 2, 2016

Last Update Submit

February 16, 2017

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (4)

  • Medical Outcomes Study Sleep Measure

    Measuring sleep quality and quantity.

    Change from Baseline Medical Outcomes Study Sleep Measure at 7 weeks

  • PROMIS Sleep Disturbances Scale (short form)

    Measuring sleep quality and quantity.

    Change from Baseline PROMIS Sleep Disturbances Scale (short form) at 7 weeks

  • Pittsburgh Sleep Quality Index Addendum for PTSD

    Measuring sleep quality and quantity.

    Change from Baseline Pittsburgh Sleep Quality Index Addendum for PTSD at 7 weeks

  • Insomnia Severity Index

    Measures severity of sleep-onset, sleep maintenance, early morning awakening, satisfaction with current sleep, interference with daily function, noticeability of impairments related to sleep problems, and level of distress caused by sleep problems.

    Change from Baseline Insomnia Severity Index at 7 weeks

Study Arms (2)

REST - Early Group

EXPERIMENTAL

Intervention - 7 weeks of sleep skills education provided in group and one-on-one format

Behavioral: REST - Early Group

REST - Late Group

EXPERIMENTAL

Control - No treatment for 7 weeks, then provided 7 weeks of sleep skills education provided in group and one-on-one format

Behavioral: REST - Late Group

Interventions

REST - Early GroupBEHAVIORAL

Intervention - 7 weeks of sleep skills education provided in group and one-on-one format

REST - Early Group
REST - Late GroupBEHAVIORAL

Control for REST - Early Group, then provided group and one-on-one sleep education and sleep skills intervention

REST - Late Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • enrolled in university classes
  • age 18 or older
  • self-report a service-related injury
  • present a U.S. Military DD-214 form indicating honorable separation from service
  • or higher on the Insomnia Severity Index

You may not qualify if:

  • Unstable bipolar disorder
  • active seizure disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80521, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 18, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

US(1)