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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Addiction
• Intervention / Treatment: Behavioral: Recovery Sleepers program.; Behavioral: Email recommendations

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recovery Sleepers program.	Behavioral: Recovery Sleepers program.; 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.
Placebo Comparator: Email recommendations	Behavioral: Email recommendations; Receive recommendations (via email) to help improve sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
Study participant retention	Percent of participants who complete all 6 weeks of the study	6 weeks
Study material completion	Percent of participant who complete all of the study materials over the course of the study	6 weeks
Study group attendance	Percent of participants who attend all study group meetings	6 weeks
Recruitment success	Number of participants recruited into the study	Baseline

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Society for Health Psychology
• Investigators: Principal Investigator: Natalie Dautovich, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2021
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: HM20022646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No