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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05114577
Collaborator
Society for Health Psychology (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Recovery Sleepers program.
  • Behavioral: Email recommendations
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
Actual Study Start Date :
Oct 24, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with treatment [6 weeks]

    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.

  2. Study participant retention [6 weeks]

    Percent of participants who complete all 6 weeks of the study

  3. Study material completion [6 weeks]

    Percent of participant who complete all of the study materials over the course of the study

  4. Study group attendance [6 weeks]

    Percent of participants who attend all study group meetings

  5. Recruitment success [Baseline]

    Number of participants recruited into the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • Society for Health Psychology

Investigators

  • Principal Investigator: Natalie Dautovich, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05114577
Other Study ID Numbers:
  • HM20022646
First Posted:
Nov 10, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022