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Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery

Primary Purpose

Sleep, Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Sleepers program.
Email recommendations
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • More than 18 years of age
  • Enrolled (full- or part-time) at a college or university
  • Have struggled with substance addiction in the past
  • More than 3 months of self-reported continuous abstinence from alcohol and all illegal drugs
  • Have an Internet-enabled device with audio capabilities.

Exclusion Criteria:

  • Younger than 18 years of age
  • Not enrolled at VCU
  • Have not struggled with substance addiction in the past
  • Have not had at least 3 months of self-reported continuous abstinence from alcohol and all
  • illegal drugs
  • In active treatment for a sleep disorder (seen a health provider specifically regarding sleep within the last 6 months)
  • Unable to communicate in English both orally and in writing
  • Do not have an Internet-enabled device with audio capabilities.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Recovery Sleepers program.

Email recommendations

Arm Description

Outcomes

Primary Outcome Measures

Satisfaction with treatment
Participants will rate their experiences in the study using a scale from 1 (Strongly disagree) to 5 (Strongly agree). Treatment and placebo groups will answer a different number of questions. Scores will be averaged to yield a single score between 1 and 5.
Study participant retention
Percent of participants who complete all 6 weeks of the study
Study material completion
Percent of participant who complete all of the study materials over the course of the study
Study group attendance
Percent of participants who attend all study group meetings
Recruitment success
Number of participants recruited into the study

Secondary Outcome Measures

Full Information

First Posted
October 29, 2021
Last Updated
December 12, 2022
Sponsor
Virginia Commonwealth University
Collaborators
Society for Health Psychology
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1. Study Identification

Unique Protocol Identification Number
NCT05114577
Brief Title
Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
Official Title
Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2021 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Society for Health Psychology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this research study is to examine how to improve sleep in college students in recovery from substance use disorder(s). This study is a pilot test of an experimental program called Recovery Sleepers (RS) to explore its feasibility and how well it works to improve sleep, wellbeing, and cravings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Addiction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery Sleepers program.
Arm Type
Experimental
Arm Title
Email recommendations
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Recovery Sleepers program.
Intervention Description
Attend two, 90-minute remote discussion groups (~10 other participants and 2 study team members) via Zoom. During these groups, participants will receive educational materials about how to improve sleep. They will also discuss sleep and sleep-related behaviors, including how active substance use and recovery may have changed sleep, with a small group of other participants.
Intervention Type
Behavioral
Intervention Name(s)
Email recommendations
Intervention Description
Receive recommendations (via email) to help improve sleep
Primary Outcome Measure Information:
Title
Satisfaction with treatment
Description
Participants will rate their experiences in the study using a scale from 1 (Strongly disagree) to 5 (Strongly agree). Treatment and placebo groups will answer a different number of questions. Scores will be averaged to yield a single score between 1 and 5.
Time Frame
6 weeks
Title
Study participant retention
Description
Percent of participants who complete all 6 weeks of the study
Time Frame
6 weeks
Title
Study material completion
Description
Percent of participant who complete all of the study materials over the course of the study
Time Frame
6 weeks
Title
Study group attendance
Description
Percent of participants who attend all study group meetings
Time Frame
6 weeks
Title
Recruitment success
Description
Number of participants recruited into the study
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than 18 years of age Enrolled (full- or part-time) at a college or university Have struggled with substance addiction in the past More than 3 months of self-reported continuous abstinence from alcohol and all illegal drugs Have an Internet-enabled device with audio capabilities. Exclusion Criteria: Younger than 18 years of age Not enrolled at VCU Have not struggled with substance addiction in the past Have not had at least 3 months of self-reported continuous abstinence from alcohol and all illegal drugs In active treatment for a sleep disorder (seen a health provider specifically regarding sleep within the last 6 months) Unable to communicate in English both orally and in writing Do not have an Internet-enabled device with audio capabilities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Dautovich, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery

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